Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-11
120
Participants Needed
76
Research Sites
53 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new treatments and combinations for people with metastatic colorectal cancer mCRC in this Phase II, global study. The study focuses on participants with Mismatch-repair-proficient pMMR and Microsatellite stable MSS mCRC who have not received previous systemic treatment for advanced disease and do not have liver metastases. The goal is to assess the safety and effectiveness of these treatments in this specific group. Participants are randomly assigned to one of two groups one group receives the study drug volrustomig combined with FOLFIRI a chemotherapy regimen including irinotecan, 5-fluorouracil, and leucovorin and bevacizumab, while the other group receives only FOLFIRI and bevacizumab. All drugs are administered by intravenous infusion. This master protocol includes multiple substudies and will compare the treatment effects over approximately three years. During the study, participants will undergo regular assessments including scans to measure disease progression, safety monitoring for adverse events, and laboratory tests to track drug levels and immune responses. Researchers will measure progression-free survival and record any side effects throughout about three years of follow-up. Additional outcomes like overall survival, response rates, and duration of response will also be evaluated. Participants health status and organ functions will be monitored to ensure ongoing safety.
CONDITIONS
Brief Title
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed colorectal adenocarcinoma.
- Provision of formalin-fixed paraffin-embedded tumor sample collected as per standard of care.
- Presence of measurable disease by RECIST 1.1 criteria.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks at screening.
- No radiological evidence of liver metastasis.
- No prior systemic therapy for metastatic colorectal cancer, except adjuvant/neoadjuvant chemotherapy completed over 6 months ago.
- Known mismatch-repair-proficient/microsatellite stable status.
- Adequate organ and bone marrow function.
- Body weight over 35 kg at screening and randomization.
- Use of contraception consistent with local regulations during the study.
You will not qualify if you...
- Central nervous system metastases or spinal cord compression.
- History of severe allergy to any monoclonal antibody or study drug.
- Unresolved toxicity Grade 2 or higher from previous anticancer therapy.
- History of another primary cancer.
- Potentially resectable disease planned for radical surgery.
- Active or prior autoimmune, inflammatory, or cardiac conditions.
- History of hypertensive crisis, encephalopathy, or bleeding risks.
- History of blood clots or cerebrovascular events.
- History of abdominal or tracheoesophageal fistula, gastrointestinal perforation, fistulae, or intraabdominal abscess within 6 months.
- Prior exposure to immune-mediated therapy.
Research Team
A
AstraZeneca Clinical Study Information Center
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