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

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

CRC-directed Trial

Yes

Tags

MSS/ MMRp

Comments

No liver mets allowed, no prior tx in the mestastatic setting. Bispecific immunotherapy MEDI5752 (anti PD-1 plus anti CTLA4)

Randomized. Volrustomig + FOLFIRI+ Bevacizumab vs FOLFIRI+ Bevacizumab (SOC)

Helpful Links

Location	Location Status
United States
Research Site Scottsdale, Arizona 85259	Recruiting
Research Site Los Angeles, California 90089	Recruiting
Research Site Washington D.C., District of Columbia 20007	Not yet recruiting
Research Site Chicago, Illinois 60637	Not yet recruiting
Research Site Baltimore, Maryland 21224	Recruiting
Research Site Boston, Massachusetts 02114	Not yet recruiting
Research Site Rochester, Minnesota 55905	Recruiting
Research Site Trenton, New Jersey 08690	Not yet recruiting
Research Site Rochester, New York 14618	Not yet recruiting
Research Site Cleveland, Ohio 44106	Withdrawn
Research Site Portland, Oregon 97239	Not yet recruiting
Research Site Philadelphia, Pennsylvania 19104	Withdrawn
Research Site Nashville, Tennessee 37232	Not yet recruiting
Research Site Houston, Texas 77030	Not yet recruiting
Australia
Research Site East Melbourne 3002	Recruiting
Research Site Wollongong 2500	Recruiting
Research Site Woodville South 5011	Recruiting
Canada
Research Site Victoria, British Columbia V8R 6V5	Not yet recruiting
Research Site Barrie, Ontario L4M 6M2	Not yet recruiting
Research Site Toronto, Ontario M5G 1X6	Recruiting
Research Site Montreal, Quebec H3T 1E2	Not yet recruiting
China
Research Site Beijing 100142	Not yet recruiting
Research Site Chengdu 610041	Not yet recruiting
Research Site Harbin 150081	Not yet recruiting
Research Site Shanghai 200003	Not yet recruiting
Research Site Shanghai 200032	Not yet recruiting
Research Site Shanghai 201114	Not yet recruiting
Research Site Wuhan 430079	Not yet recruiting
Research Site Zhengzhou 450000	Not yet recruiting
France
Research Site Bordeaux 33076	Not yet recruiting
Research Site Marseille 13273	Not yet recruiting
Research Site Montpellier 34090	Not yet recruiting
Research Site Montpellier 34298	Not yet recruiting
Research Site Poitiers 86021	Not yet recruiting
Research Site Saint-Priez En Jarez 42270	Not yet recruiting
Research Site Villejuif 94805	Recruiting
Germany
Research Site Berlin 10117	Not yet recruiting
Research Site Dresden 01307	Not yet recruiting
Research Site Essen 45147	Not yet recruiting
Research Site Hamburg 22763	Recruiting
Research Site Marburg 35043	Not yet recruiting
Italy
Research Site Bologna 40133	Not yet recruiting
Research Site Castelfranco Veneto 31033	Not yet recruiting
Research Site Florence 50134	Recruiting
Research Site Milan 20133	Not yet recruiting
Research Site Milan 20162	Not yet recruiting
Research Site Napoli 80131	Not yet recruiting
Research Site Pavia 27100	Not yet recruiting
Research Site Pisa 56100	Not yet recruiting
Research Site Roma 00168	Not yet recruiting
Netherlands
Research Site Amsterdam 1066 CX	Not yet recruiting
Research Site Maastricht 6202 AZ	Not yet recruiting
Research Site Zwolle 8025 AB	Recruiting
South Korea
Research Site Seoul 03080	Recruiting
Research Site Seoul 06351	Recruiting
Research Site Seoul 06591	Recruiting
Research Site Seoul 5505	Recruiting
Research Site Yongin-si 16995	Recruiting
Spain
Research Site Barcelona 08035	Recruiting
Research Site Barcelona 8003	Recruiting
Research Site Madrid 28007	Not yet recruiting
Research Site Madrid 28034	Not yet recruiting
Research Site Madrid 28041	Not yet recruiting
Research Site Málaga 29010	Not yet recruiting
Research Site Pamplona 31005	Recruiting
Research Site Santander 39008	Not yet recruiting
Research Site Valencia 46010	Recruiting
Taiwan
Research Site Kaohsiung City 80756	Recruiting
Research Site Taipei 10002	Recruiting
Research Site Taoyuan District 333	Recruiting
Research Site Yung Kang City 71044	Recruiting
United Kingdom
Research Site Cambridge CB2 0XY	Recruiting
Research Site London NW1 2PG	Recruiting
Research Site London W12 0HS	Recruiting
Research Site Manchester M20 4GJ	Recruiting
Research Site Metropolitan Borough of Wirral CH63 4JY	Recruiting

Contacts

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479 information.center@astrazeneca.com

Inclusion 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

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.

NCT ID

NCT06792695

Date Trial Added

2025-01-27

Updated Date

2025-10-07