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NCT06792695PHASE2Recruiting

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

AstraZeneca

Start Date

3/12/2025

Completion Date

9/29/2028

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).

Detailed Description

This is a Phase II, platform, open-label, multi-drug, multicenter, global study. This is a modular study, that includes a master protocol and substudies. Partcipants will be randomised to one of the following intervention groups: * Volrustomig + FOLFIRI + bevacizumab group (Arm A) * FOLFIRI + bevacizumab group (Arm B) The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.

Eligibility Criteria

Age Range: 18 years to 130 years

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.

Interventions

DRUG

Volrustomig

DRUG

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

DRUG

Bevacizumab

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Conditions

Metastatic Colorectal Cancer

Locations

Research Site

Scottsdale, Arizona 85259

United States

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Los Angeles, California 90089

United States

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Washington D.C., District of Columbia 20007

United States

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Chicago, Illinois 60637

United States

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Baltimore, Maryland 21224

United States

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Boston, Massachusetts 02114

United States

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Rochester, Minnesota 55905

United States

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Trenton, New Jersey 08690

United States

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Rochester, New York 14618

United States

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Cleveland, Ohio 44106

United States

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Portland, Oregon 97239

United States

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Philadelphia, Pennsylvania 19104

United States

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Nashville, Tennessee 37232

United States

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Houston, Texas 77030

United States

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East Melbourne, 3002

Australia

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Wollongong, 2500

Australia

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Woodville South, 5011

Australia

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Victoria, British Columbia V8R 6V5

Canada

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Barrie, Ontario L4M 6M2

Canada

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Toronto, Ontario M5G 1X6

Canada

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Montreal, Quebec H3T 1E2

Canada

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Beijing, 100142

China

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Chengdu, 610041

China

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Harbin, 150081

China

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Shanghai, 200003

China

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Shanghai, 200032

China

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Shanghai, 201114

China

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Wuhan, 430079

China

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Zhengzhou, 450000

China

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Bordeaux, 33076

France

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Marseille, 13273

France

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Montpellier, 34090

France

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Montpellier, 34298

France

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Poitiers, 86021

France

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Saint-Priez En Jarez, 42270

France

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Villejuif, 94805

France

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Berlin, 10117

Germany

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Dresden, 01307

Germany

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Essen, 45147

Germany

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Hamburg, 22763

Germany

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Marburg, 35043

Germany

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Bologna, 40133

Italy

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Castelfranco Veneto, 31033

Italy

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Florence, 50134

Italy

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Milan, 20133

Italy

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Milan, 20162

Italy

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Naples, 80131

Italy

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Pavia, 27100

Italy

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Pisa, 56100

Italy

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Roma, 00168

Italy

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Amsterdam, 1066 CX

Netherlands

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Maastricht, 6202 AZ

Netherlands

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Zwolle, 8025 AB

Netherlands

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Seoul, 03080

South Korea

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Seoul, 06351

South Korea

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Seoul, 06591

South Korea

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Seoul, 5505

South Korea

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Yongin-si, 16995

South Korea

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Barcelona, 08035

Spain

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Barcelona, 8003

Spain

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Madrid, 28007

Spain

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Madrid, 28034

Spain

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Madrid, 28041

Spain

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Málaga, 29010

Spain

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Pamplona, 31005

Spain

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Santander, 39008

Spain

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Valencia, 46010

Spain

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Kaohsiung City, 80756

Taiwan

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Taipei, 10002

Taiwan

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Taoyuan, 333

Taiwan

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Yung Kang City, 71044

Taiwan

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Cambridge, CB2 0XY

United Kingdom

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London, NW1 2PG

United Kingdom

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London, W12 0HS

United Kingdom

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Manchester, M20 4GJ

United Kingdom

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Metropolitan Borough of Wirral, CH63 4JY

United Kingdom