NCT lookup

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.

• Scottsdale, Arizona, United States
• Los Angeles, California, United States
• Washington D.C., District of Columbia, United States
• Chicago, Illinois, United States
• Baltimore, Maryland, United States
• Boston, Massachusetts, United States
• Rochester, Minnesota, United States
• Trenton, New Jersey, United States
• Rochester, New York, United States
• Cleveland, Ohio, United States
• Portland, Oregon, United States
• Philadelphia, Pennsylvania, United States
• Nashville, Tennessee, United States
• Houston, Texas, United States
• East Melbourne, Australia
• Wollongong, Australia
• Woodville South, Australia
• Victoria, British Columbia, Canada
• Barrie, Ontario, Canada
• Toronto, Ontario, Canada
• Montreal, Quebec, Canada
• Beijing, China
• Chengdu, China
• Harbin, China
• Shanghai, China
• Shanghai, China
• Shanghai, China
• Wuhan, China
• Zhengzhou, China
• Bordeaux, France
• + 46 more on CT.gov