Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectalrelating to the colon or rectum in the large bowel/intestine Cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (CRC).
Intervention / Treatment
- Drug: Volrustomig
- Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
- Drug: Bevacizumab
Inclusion Criteria:
- Histopathologically confirmed colorectal adenocarcinomacancer arising from mucus-producing glands in organs.
- 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
Substudy Inclusion Criteria:
- No radiological evidence of liver metastasiswhen the cancer has spread to other parts of the body, also known as mets.
- No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells where, > 6 months have elapsed between completion of therapy and documented date of diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of recurrent or metastatic disease.
- Known pMMR/MSS status (only pMMR/MSS mCRC allowed).
- Adequate organ and bone marrowsoft, spongy tissue found in bones that makes blood cells 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.