Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 7:15 PM
Study NCT ID:
NCT03815058
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-23', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization', 'timeFrame': 'The time from randomization to disease progression/death (up to approximately 24 months)'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Overall Survival (OS) After Randomization', 'timeFrame': 'The time from randomization to death from any cause (up to approximately 24 months).'}, {'measure': 'Duration of Response (DOR) According to RECISTv.1.1 After Randomization', 'timeFrame': 'The time from randomization up to approximately 24 months.'}, {'measure': 'Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization', 'timeFrame': 'From randomization up to approximately 24 months.', 'description': 'The 2-item GHS/HRQoL questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) uses a 7-point scale from 1=very poor to 7= excellent. Score range for GHS/HRQoL is 2-14. A negative change from baseline indicates deterioration in GHS.'}, {'measure': 'Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over', 'timeFrame': 'Up to 12 months from the time of cross-over'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to 90 days after the final dose of study drug (up to approximately 27 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Melanoma']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n* Life expectancy \\>/= 12 weeks;\n* Adequate hematologic and end-organ function;\n* Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions;\n* Tumor specimen availability;\n* Measurable disease per RECIST v1.1.\n\nExclusion criteria:\n\n* Ocular/uveal melanoma;\n* Any anti-cancer therapy with the exceptions as specified in the protocol;\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;\n* Previous splenectomy;\n* History of autoimmune disease;\n* Prior allogeneic bone marrow transplantation or prior solid organ transplantation;\n* Positive test for Human Immunodeficiency Virus (HIV) infection;\n* Active hepatitis B or C or tuberculosis;\n* Significant cardiovascular disease;\n* Known clinically significant liver disease.'}, 'identificationModule': {'nctId': 'NCT03815058', 'acronym': 'IMCODE001', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced Melanoma', 'orgStudyIdInfo': {'id': 'GO40558'}, 'secondaryIdInfos': [{'id': '2018-001773-24', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-507389-15-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety Run-in Period: Autogene Cevumeran + Pembrolizumab', 'description': 'Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of autogene cevumeran.', 'interventionNames': ['Biological: Autogene cevumeran', 'Drug: Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized Period: Arm A: Pembrolizumab', 'description': 'Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with autogene cevumeran plus pembrolizumab (Arm B) after confirmed disease progression.', 'interventionNames': ['Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab', 'description': 'Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of autogene cevumeran.', 'interventionNames': ['Biological: Autogene cevumeran', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'Autogene cevumeran', 'type': 'BIOLOGICAL', 'otherNames': ['RO7198457'], 'description': 'Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.', 'armGroupLabels': ['Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab', 'Safety Run-in Period: Autogene Cevumeran + Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['Keytruda'], 'description': 'Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.', 'armGroupLabels': ['Randomized Period: Arm A: Pembrolizumab', 'Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab', 'Safety Run-in Period: Autogene Cevumeran + Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Specialists', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt McKinley Outpatient Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Cancer Care', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital.', 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'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22906', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '5011', 'city': 'Woodville South', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.88186, 'lon': 138.53477}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum 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Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioNTech SE', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}