A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
NCT ID: NCT06792695
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-03-12
2028-06-07
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)
Participants will receive FOLFIRI and bevacizumab together with volrustomig.
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.
FOLFIRI+ BEVACIZUMAB group (Arm B)
Partcipants will receive FOLFIRI and bevacizumab.
FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
FOLFIRI will be administered as IV infusion.
Bevacizumab
Bevacizumab will be administered as IV infusion.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
130 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Scottsdale, Arizona, United States
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Los Angeles, California, United States
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Washington D.C., District of Columbia, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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Trenton, New Jersey, United States
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Rochester, New York, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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East Melbourne, , Australia
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Wollongong, , Australia
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Woodville South, , Australia
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Victoria, British Columbia, Canada
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Barrie, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Chengdu, , China
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Harbin, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Wuhan, , China
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Zhengzhou, , China
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Bordeaux, , France
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Marseille, , France
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Montpellier, , France
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Montpellier, , France
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Poitiers, , France
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Saint-Priez En Jarez, , France
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Villejuif, , France
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Berlin, , Germany
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Dresden, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Marburg, , Germany
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Bologna, , Italy
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Castelfranco Veneto, , Italy
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Amsterdam, , Netherlands
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Maastricht, , Netherlands
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Zwolle, , Netherlands
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Yongin-si, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Pamplona, , Spain
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Santander, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Yung Kang City, , Taiwan
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Cambridge, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2024-518469-84
Identifier Type: REGISTRY
Identifier Source: secondary_id
D798VC00001
Identifier Type: -
Identifier Source: org_study_id