Volrustomig: Volrustomig will be administered as intravenous (IV) infusion.
FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan): FOLFIRI will be administered as IV infusion.
Bevacizumab: Bevacizumab will be administered as IV infusion.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Overall 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.
Primary outcome measure(s)
Progression Free Survival (PFS) — Approximately 3 years 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.
Number of Participants with Adverse Events (AEs) — Approximately 3 years Number of participants who received at least one dose of study treatment will be assessed.
Trial sites (76)
Facility
City
Region
Status
Research Site
Scottsdale
Arizona
Recruiting
Research Site
Los Angeles
California
Recruiting
Research Site
Washington D.C.
District of Columbia
Recruiting
Research Site
Chicago
Illinois
Not Yet Recruiting
Research Site
Baltimore
Maryland
Recruiting
Research Site
Boston
Massachusetts
Completed
Research Site
Rochester
Minnesota
Recruiting
Research Site
Trenton
New Jersey
Recruiting
Research Site
Rochester
New York
Recruiting
Research Site
Cleveland
Ohio
Withdrawn
Research Site
Portland
Oregon
Not Yet Recruiting
Research Site
Philadelphia
Pennsylvania
Withdrawn
Research Site
Nashville
Tennessee
Not Yet Recruiting
Research Site
Houston
Texas
Recruiting
Research Site
East Melbourne
Australia
Recruiting
Research Site
Wollongong
Australia
Recruiting
Research Site
Woodville South
Australia
Recruiting
Research Site
Victoria
British Columbia
Recruiting
Research Site
Barrie
Ontario
Recruiting
Research Site
Toronto
Ontario
Recruiting
Research Site
Montreal
Quebec
Recruiting
Research Site
Beijing
China
Not Yet Recruiting
Research Site
Chengdu
China
Suspended
Research Site
Harbin
China
Not Yet Recruiting
Research Site
Shanghai
China
Not Yet Recruiting
Research Site
Shanghai
China
Suspended
Research Site
Shanghai
China
Not Yet Recruiting
Research Site
Wuhan
China
Suspended
Research Site
Zhengzhou
China
Suspended
Research Site
Bordeaux
France
Suspended
Research Site
Marseille
France
Withdrawn
Research Site
Montpellier
France
Recruiting
Research Site
Montpellier
France
Suspended
Research Site
Poitiers
France
Recruiting
Research Site
Saint-Priez En Jarez
France
Recruiting
Research Site
Villejuif
France
Recruiting
Research Site
Berlin
Germany
Recruiting
Research Site
Dresden
Germany
Recruiting
Research Site
Essen
Germany
Recruiting
Research Site
Hamburg
Germany
Recruiting
+ 36 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.