Ireland
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Active, not 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
Phase
Phase 2
Started
2025-03-12
Last updated
2026-10-22

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

Volrustomig →FOLFIRI (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, prior neoadjuvant/adjuvant chemotherapy is permitted only when given for resected (M0) disease and only after at least 6 months have elapsed since completion of that therapy and 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. * History of active primary immunodeficiency.

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 (56)

FacilityCityRegionStatus
Research Site Scottsdale Arizona
Research Site Los Angeles California
Research Site Washington D.C. District of Columbia
Research Site Baltimore Maryland
Research Site Boston Massachusetts
Research Site Rochester Minnesota
Research Site Trenton New Jersey
Research Site Rochester New York
Research Site Nashville Tennessee
Research Site Houston Texas
Research Site East Melbourne Australia
Research Site Wollongong Australia
Research Site Woodville South Australia
Research Site Victoria British Columbia
Research Site Barrie Ontario
Research Site Toronto Ontario
Research Site Montreal Quebec
Research Site Beijing China
Research Site Montpellier France
Research Site Poitiers France
Research Site Saint-Priez En Jarez France
Research Site Villejuif France
Research Site Berlin Germany
Research Site Dresden Germany
Research Site Essen Germany
Research Site Hamburg Germany
Research Site Marburg Germany
Research Site Bologna Italy
Research Site Florence Italy
Research Site Milan Italy
Research Site Naples Italy
Research Site Amsterdam Netherlands
Research Site Maastricht Netherlands
Research Site Zwolle Netherlands
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Yongin-si South Korea
Research Site Barcelona Spain

+ 16 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