Recruiting
Phase 2

Colorectal Cancer

Sponsor:

AstraZeneca

Code:

NCT06792695

Conditions

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Volrustomig

FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)

Bevacizumab

Study Details

Brief 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).

Conditions

Metastatic Colorectal Cancer

Study ID

NCT06792695

Start date

Mar 12, 2025

Status verified date

Aug, 2026

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)

Participants will receive FOLFIRI and bevacizumab together with volrustomig.

active comparator: FOLFIRI+ BEVACIZUMAB group (Arm B)

Partcipants will receive FOLFIRI and bevacizumab.

Interventions

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.

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: Approximately 3 years ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 3 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Scottsdale, Arizona, United States, 85259

Research Site

Recruiting

Los Angeles, California, United States, 90089

Research Site

Recruiting

Washington D.C., District of Columbia, United States, 20007

Research Site

Recruiting

Baltimore, Maryland, United States, 21224

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

Research Site

Recruiting

Trenton, New Jersey, United States, 08690

Research Site

Recruiting

Rochester, New York, United States, 14618

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Research Site

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 1X6

Research Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

AstraZeneca

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Metastatic disease
  • Immunotherapy
  • Liver metastasis
  • Mismatch-repair-proficient
  • Antibody targeting
  • Colorectal Cancer
  • CANTOR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-18.