A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

Launched by ASTRAZENECA · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring new treatment options for people with metastatic colorectal cancer, which means the cancer has spread beyond its original site. The main goal is to see how safe and effective these new treatments and combinations are for patients. The study is currently looking for participants aged between 65 and 80, regardless of gender, who have been diagnosed with colorectal adenocarcinoma and have measurable disease. To be eligible, participants need to have a good performance status, meaning they can carry out daily activities with little trouble, and must expect to live for at least 12 weeks.

If you or a loved one are considering joining this trial, you can expect to receive close medical supervision and regular assessments during the study. It's important to note that participants should not have certain health conditions, such as central nervous system metastases or severe allergies to study medications, and should not have received specific prior treatments for their cancer. This trial offers an opportunity to access potentially promising new therapies while contributing to research that could benefit future patients.

Gender

ALL

Eligibility criteria

• 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.