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Clinical Trials in the USA / NCT06792695
Recruiting Phase 2

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

NCT06792695 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2025-03-12
Last updated
2026-08-18

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

VolrustomigFOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)Bevacizumab

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)

Trial sites (76)

FacilityCityRegionStatus
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.

Official registry record

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.

View NCT06792695 on ClinicalTrials.gov ↗ ← All trials in the USA