Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT01507103
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2012-01-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tecemotide (L-BLP25) in Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518273', 'term': 'L-BLP25'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Serono, a division of Merck KGaA'}, 'certainAgreement': {'otherDetails': 'The Investigator will inform the Sponsor in advance about any plans to publish or present data from the trial. Any publications and presentations of the results (abstracts in journals or newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their representatives will require pre-submission review by the Sponsor.\n\nThe Sponsor will not suppress or veto publications, but maintains the right to delay publication in order to protect intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Not all efficacy data were analyzed as no acceptable ELISpot assay is available. The Sponsor decided to discontinue the development of tecemotide (L-BLP25) in September 2014'}}, 'adverseEventsModule': {'timeFrame': 'Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18).', 'description': "TEAEs: AE's during treatment; absent pre-treatment (PT)/worsened relative to PT \\& onset dates occurring from first trial treatment till the Follow-up/EOT. Safety Analysis Set included all randomized subjects; received at least 1 dose of treatment (arm A:one dose of CPA, arm B:one s.c. injection of tecemotide, arm C:neo-adjuvant chemoradiotherapy).", 'eventGroups': [{'id': 'EG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+CPA', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.', 'otherNumAtRisk': 39, 'otherNumAffected': 38, 'seriousNumAtRisk': 39, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.', 'otherNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.', 'otherNumAtRisk': 42, 'otherNumAffected': 41, 'seriousNumAtRisk': 42, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Defaecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Painful defaecation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Rectal tenesmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Antinuclear antibody increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 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{'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Aortic thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version17.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.'}], 'classes': [{'title': 'CD8+ (n=23, 27, 26)', 'categories': [{'measurements': [{'value': '0.609', 'spread': '5.4241', 'groupId': 'OG000'}, {'value': '0.543', 'spread': '4.5009', 'groupId': 'OG001'}, {'value': '1.538', 'spread': '3.9509', 'groupId': 'OG002'}]}]}, {'title': 'CD8+/GrB+ (n=23, 27, 26)', 'categories': [{'measurements': [{'value': '0.565', 'spread': '3.1646', 'groupId': 'OG000'}, {'value': '0.216', 'spread': '2.4187', 'groupId': 'OG001'}, {'value': '0.936', 'spread': '2.7649', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.794', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Effect estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.65', 'pValueComment': 'Arm effect', 'groupDescription': 'Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an analysis of covariance (ANCOVA) model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.794', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Effect estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.43', 'pValueComment': 'Arm effect', 'groupDescription': 'Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.794', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Effect estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.82', 'pValueComment': 'Arm effect', 'groupDescription': 'Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.654', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Effect estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.57', 'pValueComment': 'Arm effect', 'groupDescription': 'Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.654', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Effect estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.31', 'pValueComment': 'Arm effect', 'groupDescription': 'Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Effect estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.74', 'pValueComment': 'Arm effect', 'groupDescription': 'Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 14 (post-surgery)', 'description': 'Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.', 'unitOfMeasure': 'TILs per 100 tumor cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analyzed for each category.'}, {'type': 'PRIMARY', 'title': 'Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.921', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.67', 'estimateComment': 'Difference between Means adjusted on covariates baseline value and MSI category.', 'groupDescription': 'Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.921', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Means estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.44', 'estimateComment': 'Difference between Means adjusted on covariates baseline value and MSI category.', 'groupDescription': 'Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.83', 'estimateComment': 'Difference between Means adjusted on covariates baseline value and MSI category.', 'groupDescription': 'Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.890', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.58', 'estimateComment': 'Difference between Means adjusted on covariates baseline value and MSI category.', 'groupDescription': 'Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.890', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Means estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.31', 'estimateComment': 'Difference between Means adjusted on covariates baseline value and MSI category.', 'groupDescription': 'Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.890', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.74', 'estimateComment': 'Difference between Means adjusted on covariates baseline value and MSI category.', 'groupDescription': 'Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.', 'statisticalMethod': 'type III SS F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks', 'description': 'A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.'}], 'timeFrame': 'Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)', 'description': 'IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not analyzed as no acceptable ELISpot assay is available'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.'}], 'timeFrame': 'Baseline and Week 14 (post-surgery)', 'description': 'Immunological changes in the tumor microenvironment were evaluated based on IHC expression of CD3+, CD4+, and Ki67+CD3+ T cells; regulatory T cells (FOXP3+) and myeloid-derived suppressor cells (CD33+CD14-); other immune cells such as NK cells (CD3-CD57+), B cells (CD20+), macrophages (CD68+), and dendritic cells (S100+). Peritumoral immune response was calculated as number of lymphoid cells at the margin of the tumor or in the tumor bed (if there is complete pathological response).', 'reportingStatus': 'POSTED', 'populationDescription': 'The pre-specified statistical threshold for reporting of results of planned analysis for either arm or interaction effect was not met in the analysis population. Hence the data was not assessed for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.'}], 'classes': [{'title': 'CD3-CD56+CD16+GranzymeB+ (n=26,30,24)', 'categories': [{'measurements': [{'value': '-0.013', 'spread': '0.1051', 'groupId': 'OG000'}, {'value': '-0.046', 'spread': '0.1259', 'groupId': 'OG001'}, {'value': '-0.081', 'spread': '0.2238', 'groupId': 'OG002'}]}]}, {'title': 'CD3-CD56+CD16+Perforin+ (n=26,30,24)', 'categories': [{'measurements': [{'value': '-0.050', 'spread': '0.0769', 'groupId': 'OG000'}, {'value': '-0.033', 'spread': '0.1868', 'groupId': 'OG001'}, {'value': '-0.088', 'spread': '0.2282', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD4+CD27+ (n=26,30,24)', 'categories': [{'measurements': [{'value': '-0.181', 'spread': '0.1848', 'groupId': 'OG000'}, {'value': '-0.135', 'spread': '0.1521', 'groupId': 'OG001'}, {'value': '-0.099', 'spread': '0.1913', 'groupId': 'OG002'}]}]}, {'title': 'CD3-CD56+CD16+Granzyme B+/LY (n=26,30,24)', 'categories': [{'measurements': [{'value': '0.264', 'spread': '0.5885', 'groupId': 'OG000'}, {'value': '0.047', 'spread': '1.2787', 'groupId': 'OG001'}, {'value': '0.415', 'spread': '0.6040', 'groupId': 'OG002'}]}]}, {'title': 'CD3-CD56+CD16+Perforin+/LY (n=26,30,24)', 'categories': [{'measurements': [{'value': '0.226', 'spread': '0.5669', 'groupId': 'OG000'}, {'value': '0.058', 'spread': '1.2902', 'groupId': 'OG001'}, {'value': '0.411', 'spread': '0.6019', 'groupId': 'OG002'}]}]}, {'title': 'CD3-CD56+CD16-CD107a+ (n=26,30,24)', 'categories': [{'measurements': [{'value': '0.216', 'spread': '1.2010', 'groupId': 'OG000'}, {'value': '-0.318', 'spread': '1.5863', 'groupId': 'OG001'}, {'value': '0.037', 'spread': '1.0191', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD8+CD127-FoxP3-CD45RA-CD25+CTLA4+(n=27,29,24)', 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.3933', 'groupId': 'OG000'}, {'value': '0.152', 'spread': '0.5386', 'groupId': 'OG001'}, {'value': '-0.012', 'spread': '0.5202', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD56+CD16-Granzyme B+ (n=26,30,24)', 'categories': [{'measurements': [{'value': '0.479', 'spread': '1.6943', 'groupId': 'OG000'}, {'value': '-0.241', 'spread': '0.9628', 'groupId': 'OG001'}, {'value': '-0.024', 'spread': '0.6623', 'groupId': 'OG002'}]}]}, {'title': 'CD3-CD56+CD16+/LY (n=26,30,24)', 'categories': [{'measurements': [{'value': '0.277', 'spread': '0.5448', 'groupId': 'OG000'}, {'value': '0.090', 'spread': '1.2968', 'groupId': 'OG001'}, {'value': '0.497', 'spread': '0.6119', 'groupId': 'OG002'}]}]}, {'title': 'CD3-CD19+BTLA4+ (n=27,29,23)', 'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.0489', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.0550', 'groupId': 'OG001'}, {'value': '-0.017', 'spread': '0.0352', 'groupId': 'OG002'}]}]}, {'title': 'Lymphs Tube 2 (n=27,30,25)', 'categories': [{'measurements': [{'value': '-1.024', 'spread': '0.4392', 'groupId': 'OG000'}, {'value': '-0.941', 'spread': '0.6080', 'groupId': 'OG001'}, {'value': '-0.952', 'spread': '0.4761', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD56+CD16+CD107a+ (n=26,30,24)', 'categories': [{'measurements': [{'value': '-1.216', 'spread': '4.5484', 'groupId': 'OG000'}, {'value': '1.966', 'spread': '6.6322', 'groupId': 'OG001'}, {'value': '-2.752', 'spread': '6.4790', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD4+BTLA4+ (n=26,30,24)', 'categories': [{'measurements': [{'value': '0.063', 'spread': '1.4413', 'groupId': 'OG000'}, {'value': '0.122', 'spread': '0.4833', 'groupId': 'OG001'}, {'value': '-0.035', 'spread': '0.4117', 'groupId': 'OG002'}]}]}, {'title': 'Lymphs Tube 3 (n=27,30,25)', 'categories': [{'measurements': [{'value': '-0.994', 'spread': '0.4545', 'groupId': 'OG000'}, {'value': '-0.920', 'spread': '0.5923', 'groupId': 'OG001'}, {'value': '-0.936', 'spread': '0.4746', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD56+CD16+CCR7+ (n=26,30,24)', 'categories': [{'measurements': [{'value': '-1.341', 'spread': '4.1442', 'groupId': 'OG000'}, {'value': '0.541', 'spread': '6.3502', 'groupId': 'OG001'}, {'value': '-3.390', 'spread': '5.1877', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD8+CD127+FoxP3-CD25-CD45RA+CTLA4-(n=27,29,24)', 'categories': [{'measurements': [{'value': '-0.604', 'spread': '0.8102', 'groupId': 'OG000'}, {'value': '-1.062', 'spread': '1.1436', 'groupId': 'OG001'}, {'value': '-0.940', 'spread': '1.2678', 'groupId': 'OG002'}]}]}, {'title': 'Background corrected CD3+CD4+IFNg+ (n=21,27,21)', 'categories': [{'measurements': [{'value': '0.058', 'spread': '0.9767', 'groupId': 'OG000'}, {'value': '0.544', 'spread': '0.9521', 'groupId': 'OG001'}, {'value': '0.359', 'spread': '1.3187', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD56+CD16+Granzyme B+/LY (n=26,30,24)', 'categories': [{'measurements': [{'value': '0.243', 'spread': '0.6969', 'groupId': 'OG000'}, {'value': '-0.201', 'spread': '1.0731', 'groupId': 'OG001'}, {'value': '0.131', 'spread': '0.7652', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD56+CD16+Perforin+/LY (n=26,30,24)', 'categories': [{'measurements': [{'value': '0.240', 'spread': '0.6997', 'groupId': 'OG000'}, {'value': '-0.177', 'spread': '0.9920', 'groupId': 'OG001'}, {'value': '0.101', 'spread': '0.7617', 'groupId': 'OG002'}]}]}, {'title': 'CD3+CD4+CD127+FoxP3-CD45RA-CD25+CTLA4+(n=27,29,24)', 'categories': [{'measurements': [{'value': '0.711', 'spread': '1.3825', 'groupId': 'OG000'}, {'value': '0.674', 'spread': '1.2689', 'groupId': 'OG001'}, {'value': '1.035', 'spread': '1.4996', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 18 (follow-up / end-of trial)', 'description': 'Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale.', 'unitOfMeasure': 'log2 (percentage of T cells)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analysed for each category.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'OG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.'}], 'timeFrame': 'Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)', 'description': 'IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not analyzed as no acceptable ELISpot assay is available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+CPA', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'FG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'FG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First/last participant (informed consent): Feb 2012/Dec 2013. Study completion date: Jun 2014.', 'preAssignmentDetails': 'Enrolled: 140 screened for eligibility; 16 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria), 124 subjects randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)+CPA', 'description': 'Single dose of cyclophosphamide (300 mg/m\\^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'BG001', 'title': 'Chemoradiotherapy+Tecemotide (L-BLP25)', 'description': 'Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.'}, {'id': 'BG002', 'title': 'Chemoradiotherapy', 'description': 'Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '10.74', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '10.12', 'groupId': 'BG001'}, {'value': '60.3', 'spread': '8.77', 'groupId': 'BG002'}, {'value': '61.3', 'spread': '9.84', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all subjects who received at least one dose of study treatment (tecemotide \\[L-BLP25\\] or CPA).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2012-01-06', 'resultsFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2012-01-06', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-26', 'studyFirstPostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)', 'timeFrame': 'Baseline and Week 14 (post-surgery)', 'description': 'Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.'}, {'measure': 'Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category', 'timeFrame': '18 weeks', 'description': 'A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).'}, {'measure': 'Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline', 'timeFrame': 'Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)', 'description': 'IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.'}, {'measure': 'Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline', 'timeFrame': 'Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)', 'description': 'IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)', 'timeFrame': 'Baseline and Week 14 (post-surgery)', 'description': 'Immunological changes in the tumor microenvironment were evaluated based on IHC expression of CD3+, CD4+, and Ki67+CD3+ T cells; regulatory T cells (FOXP3+) and myeloid-derived suppressor cells (CD33+CD14-); other immune cells such as NK cells (CD3-CD57+), B cells (CD20+), macrophages (CD68+), and dendritic cells (S100+). Peritumoral immune response was calculated as number of lymphoid cells at the margin of the tumor or in the tumor bed (if there is complete pathological response).'}, {'measure': 'Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)', 'timeFrame': 'Baseline and Week 18 (follow-up / end-of trial)', 'description': 'Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tecemotide (L-BLP25)', 'Cyclophosphamide (CPA)', 'Mode of action', 'Neoplasms', 'Neoplasms by Site', 'Carcinomas', 'Antineoplastic Agents', 'Neoadjuvant', 'Radiotherapy Pharmacologic Actions', 'Immunosuppressive Agents', 'Immunologic Function', 'Therapeutic Uses', 'Molecular Mechanisms of Pharmacological Action'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy.\n\nTecemotide (L-BLP25) is designed to induce an immune response that may lead to immune rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in all colorectal cancers and since the adaptive immune system plays a role in the prognosis of rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might boost the tumor-specific immune response and increase the number of tumor-infiltrating lymphocytes (TILs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects with histologically documented resectable rectal adenocarcinoma in Stage 2-4\n2. Availability of tumor biopsy sufficient for immunological analysis\n3. Indication to receive neoadjuvant concomitant chemoradiotherapy consisting of a radiation dose of 45-52 Gy and capecitabine 825 mg/m\\^2 orally twice daily. The use of an equivalent schedule based on 5-FU is acceptable\n4. Magnetic resonance imaging small pelvis / computed tomography thorax/abdomen (or X-ray thorax) to document absence of metastatic disease. Imaging must not be older than 6 weeks prior to randomization\n5. Eastern Cooperative Oncology Group performance status of 0 or 1\n6. Written informed consent\n7. Greater than or equal to (\\>=) 18 years of age\n\nExclusion Criteria:\n\n1. Previous chemotherapy and/or previous radiotherapy of the pelvic region\n2. Relapsing disease\n3. Previous vaccination with any MUC1 vaccine and other therapeutic cancer vaccines\n4. Previous organ transplantation (bone marrow or solid organs)\n5. Subjects with metastatic disease (except for solitary, resectable liver or lung metastases)\n6. Inadequate hematological function (that is, platelet count less than 140\\*10\\^9 per liter \\[/L\\], or white blood cell less than 2.5\\*10\\^9/L, or hemoglobin less than 90 gram per liter). Clinically significant hepatic dysfunction (that is alanine aminotransferase greater than 2.5\\*upper limit of normal \\[ULN\\], or aspartate aminotransferase greater than 2.5\\*ULN, or bilirubin greater than 1.5\\*ULN). Inadequate renal function (that is serum creatinine greater than 1.5\\*ULN)\n7. Autoimmune diseases\n8. Recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies\n9. Clinically significant cardiac disease, for example, New York Heart Association Classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by medical history and an electrocardiogram\n10. Other protocol defined exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT01507103', 'acronym': 'SPRINT', 'briefTitle': 'Tecemotide (L-BLP25) in Rectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Multi-center, Randomized, Open-label, Mechanism of Action Trial on the Biological Effects of the Therapeutic Cancer Vaccine Stimuvax® (L-BLP25) in Rectal Cancer Subjects Undergoing Neoadjuvant Chemoradiotherapy', 'orgStudyIdInfo': {'id': 'EMR 63325-013'}, 'secondaryIdInfos': [{'id': '2011-000847-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemoradiotherapy+tecemotide (L-BLP25)+CPA', 'interventionNames': ['Biological: Tecemotide (L-BLP25)', 'Drug: cyclophosphamide (CPA)', 'Other: Chemoradiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Chemoradiotherapy+tecemotide (L-BLP25)', 'interventionNames': ['Biological: Tecemotide (L-BLP25)', 'Other: Chemoradiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemoradiotherapy', 'interventionNames': ['Other: Chemoradiotherapy']}], 'interventions': [{'name': 'Tecemotide (L-BLP25)', 'type': 'BIOLOGICAL', 'otherNames': ['EMD531444'], 'description': 'Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8, which will be administered concomitantly with the chemoradiotherapy, followed by a 9th subcutaneous injection 7 to 11 days prior to surgery.', 'armGroupLabels': ['Chemoradiotherapy+tecemotide (L-BLP25)', 'Chemoradiotherapy+tecemotide (L-BLP25)+CPA']}, {'name': 'cyclophosphamide (CPA)', 'type': 'DRUG', 'otherNames': ['L01AA01', 'Endoxana'], 'description': 'A single intravenous infusion of 300 milligram per square meter (mg/m\\^2) (to a maximum 600 mg) of CPA will be given 3 days before the first tecemotide (L-BLP25) administration.', 'armGroupLabels': ['Chemoradiotherapy+tecemotide (L-BLP25)+CPA']}, {'name': 'Chemoradiotherapy', 'type': 'OTHER', 'description': 'Radiotherapy of 45-52 grays (Gy) will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\\^2, twice daily or equivalent dose of 5-fluorouracil (5-FU) will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.', 'armGroupLabels': ['Chemoradiotherapy', 'Chemoradiotherapy+tecemotide (L-BLP25)', 'Chemoradiotherapy+tecemotide (L-BLP25)+CPA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'NKI (Nederlands Kanker Instituut)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Barbara Guenther', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}