Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-31 @ 10:00 AM
Study NCT ID:
NCT06792695
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Approximately 3 years', 'description': 'PFS is defined as the time from randomization until progression per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) or death due to any cause.'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Approximately 3 years', 'description': 'Number of participants who received at least one dose of study treatment will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Approximately 3 years', 'description': 'OS is defined as the time from randomization until the date of death due to any cause.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Approximately 3 years', 'description': 'ORR is defined as the proportion of participants who have a confirmed complete response or confirmed partial response as per RECIST 1.1.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Approximately 3 years', 'description': 'DCR is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1 after randomization.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Approximately 3 years', 'description': 'DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 or death due to any cause.'}, {'measure': 'Time to second progression or death (PFS2)', 'timeFrame': 'Approximately 3 years', 'description': 'PFS2 is defined as the time from randomization to the earliest of the progression event, after first subsequent therapy, or death.'}, {'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': 'Approximately 3 years', 'description': 'Concentration of novel study intervention in serum and PK parameters as data allow (such as peak and trough concentrations) will be assessed.'}, {'measure': 'Observed lowest concentration before the next dose is administered (Ctrough)', 'timeFrame': 'Approximately 3 years', 'description': 'Concentration of novel study intervention in serum and PK parameters as data allow (such as peak and trough concentrations) will be assessed.'}, {'measure': 'Number of patients with positive Antidrug Antibodies (ADAs)', 'timeFrame': 'Approximately 3 years', 'description': 'The immunogenicity (ADAs) of novel study intervention in participants with CRC in the absence of liver metastases is investigated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic disease', 'Immunotherapy', 'Liver metastasis', 'Mismatch-repair-proficient', 'Antibody targeting', 'Colorectal Cancer', 'CANTOR'], 'conditions': ['Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).', 'detailedDescription': 'This is a Phase II, platform, open-label, multi-drug, multicenter, global study.\n\nThis is a modular study, that includes a master protocol and substudies.\n\nPartcipants will be randomised to one of the following intervention groups:\n\n* Volrustomig + FOLFIRI + bevacizumab group (Arm A)\n* FOLFIRI + bevacizumab group (Arm B)\n\nThe substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Overall Inclusion Criteria:\n\n* Histopathologically confirmed colorectal adenocarcinoma.\n* Provision of FFPE tumor sample collected as per SoC.\n* Presence of measurable disease by RECIST 1.1 criteria.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks at the time of screening.\n\nSubstudy Inclusion Criteria:\n\n* No radiological evidence of liver metastasis.\n* No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, \\> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease.\n* Known pMMR/MSS status (only pMMR/MSS mCRC allowed).\n* Adequate organ and bone marrow function\n* Body weight \\> 35 kg at screening and at randomization.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nOverall Exclusion Criteria:\n\n* Central nervous system metastases or spinal cord compression\n* Known history of severe allergy to any monoclonal antibody or study intervention.\n* Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.\n* History of another primary malignancy.\n\nSubstudy Exclusion Criteria:\n\n* Potentially resectable disease with multidisciplinary plan for radical surgery.\n* Active or prior documented autoimmune or inflammatory disorders or cardiac conditions.\n* Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks.\n* Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident.\n* History of abdominal or tracheoesophageal fistula, GI perforation and/or fistulae, or intraabdominal abscess within 6 months prior to randomization.\n* Prior exposure to immune mediated therapy.'}, 'identificationModule': {'nctId': 'NCT06792695', 'acronym': 'CANTOR', 'briefTitle': 'A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)', 'orgStudyIdInfo': {'id': 'D798VC00001'}, 'secondaryIdInfos': [{'id': '2024-518469-84', 'type': 'REGISTRY', 'domain': 'EU (CTIS)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)', 'description': 'Participants will receive FOLFIRI and bevacizumab together with volrustomig.', 'interventionNames': ['Drug: Volrustomig', 'Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)', 'Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFIRI+ BEVACIZUMAB group (Arm B)', 'description': 'Partcipants will receive FOLFIRI and bevacizumab.', 'interventionNames': ['Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Volrustomig', 'type': 'DRUG', 'otherNames': ['MEDI5752'], 'description': 'Volrustomig will be administered as intravenous (IV) infusion.', 'armGroupLabels': ['Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)']}, {'name': 'FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)', 'type': 'DRUG', 'description': 'FOLFIRI will be administered as IV infusion.', 'armGroupLabels': ['FOLFIRI+ BEVACIZUMAB group (Arm B)', 'Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab will be administered as IV infusion.', 'armGroupLabels': ['FOLFIRI+ BEVACIZUMAB group (Arm B)', 'Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'status': 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