A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
Purpose
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).
Condition
- Metastatic Colorectal Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 130 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histopathologically confirmed colorectal adenocarcinoma. - Provision of FFPE tumor sample collected as per SoC. - Presence of measurable disease by RECIST 1.1 criteria. - ECOG performance status of 0 or 1. - Life expectancy ≥ 12 weeks at the time of screening. Substudy Inclusion Criteria: - No radiological evidence of liver metastasis. - 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. - Known pMMR/MSS status (only pMMR/MSS mCRC allowed). - Adequate organ and bone marrow function - Body weight > 35 kg at screening and at randomization. - Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Overall
Exclusion Criteria
- Central nervous system metastases or spinal cord compression - Known history of severe allergy to any monoclonal antibody or study intervention. - Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy. - History of another primary malignancy. Substudy Exclusion Criteria: - Potentially resectable disease with multidisciplinary plan for radical surgery. - Active or prior documented autoimmune or inflammatory disorders or cardiac conditions. - Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks. - Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident. - History of abdominal or tracheoesophageal fistula, GI perforation and/or fistulae, or intraabdominal abscess within 6 months prior to randomization. - Prior exposure to immune mediated therapy.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Volrustomig + FOLFIRI+ Bevacizumab group (Arm A) |
Participants will receive FOLFIRI and bevacizumab together with volrustomig. |
|
|
Active Comparator FOLFIRI+ BEVACIZUMAB group (Arm B) |
Partcipants will receive FOLFIRI and bevacizumab. |
|
Recruiting Locations
Research Site
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
Research Site
Los Angeles, California 90089
Los Angeles, California 90089
Research Site
Baltimore, Maryland 21224
Baltimore, Maryland 21224
Research Site
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Research Site
Rochester, New York 14618
Rochester, New York 14618
Research Site
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed Description
This is a Phase II, platform, open-label, multi-drug, multicenter, global study. This is a modular study, that includes a master protocol and substudies. Partcipants will be randomised to one of the following intervention groups: - Volrustomig + FOLFIRI + bevacizumab group (Arm A) - FOLFIRI + bevacizumab group (Arm B) The 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.