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

Recruiting · NCT06792695 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

BevacizumabFOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)Volrustomig

What this trial is about

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).

Who can take part

Age range

18 Years to 130 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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.
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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.

Where it is running

60 locations listed across 14 US states.

Research Site - Scottsdale, Arizona, United States
Research Site - Los Angeles, California, United States
Research Site - Washington D.C., District of Columbia, United States
Research Site - Chicago, Illinois, United States
Research Site - Baltimore, Maryland, United States
Research Site - Boston, Massachusetts, United States
Research Site - Rochester, Minnesota, United States
Research Site - Trenton, New Jersey, United States
Research Site - Rochester, New York, United States
Research Site - Cleveland, Ohio, United States
Research Site - Portland, Oregon, United States
Research Site - Philadelphia, Pennsylvania, United States
Research Site - Nashville, Tennessee, United States
Research Site - Houston, Texas, United States
Research Site - Amsterdam, Netherlands
Research Site - Barcelona, Spain
Research Site - Barcelona, Spain
Research Site - Beijing, China
Research Site - Berlin, Germany
Research Site - Bologna, Italy
Research Site - Bordeaux, France
Research Site - Cambridge, United Kingdom
Research Site - Castelfranco Veneto, Italy
Research Site - Chengdu, China
Research Site - Dresden, Germany
Research Site - East Melbourne, Australia
Research Site - Essen, Germany
Research Site - Florence, Italy
Research Site - Hamburg, Germany
Research Site - Harbin, China
Research Site - Kaohsiung City, Taiwan
Research Site - London, United Kingdom
Research Site - London, United Kingdom
Research Site - Maastricht, Netherlands
Research Site - Madrid, Spain
Research Site - Madrid, Spain
Research Site - Madrid, Spain
Research Site - Manchester, United Kingdom
Research Site - Marburg, Germany
Research Site - Marseille, France
Research Site - Metropolitan Borough of Wirral, United Kingdom
Research Site - Milan, Italy
Research Site - Milan, Italy
Research Site - Montpellier, France
Research Site - Montpellier, France
Research Site - Málaga, Spain
Research Site - Naples, Italy
Research Site - Pamplona, Spain
Research Site - Pavia, Italy
Research Site - Pisa, Italy
Research Site - Poitiers, France
Research Site - Roma, Italy
Research Site - Saint-Priez En Jarez, France
Research Site - Santander, Spain
Research Site - Seoul, South Korea
Research Site - Seoul, South Korea
Research Site - Seoul, South Korea
Research Site - Seoul, South Korea
Research Site - Shanghai, China
Research Site - Shanghai, China

Showing 60 of 76 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →