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Recruiting Phase 2/3 NCT07221357

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Phase 2/3 – combined trial
Conditions: Untreated, Unresectable, or Metastatic Colorectal Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
Who can participate
Inclusion Criteria * Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery. * Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used). * Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing. * Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression. * Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence. * Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome. * Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy. * Other protocol-defined Inclusion/Exclusion criteria apply.
Locations 25
Argentina (1)
Local Institution - 0071
ABB , Buenos Aires F.D.
NOT_YET_RECRUITING
Australia (1)
Local Institution - 0277
Liverpool , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Local Institution - 0622
Bonheiden , Antwerpen
NOT_YET_RECRUITING
Brazil (1)
Local Institution - 0267
Curitiba , Paraná
NOT_YET_RECRUITING
Canada (1)
Local Institution - 0550
Calgary , Alberta
NOT_YET_RECRUITING
Chile (1)
Local Institution - 0171
Recoleta , Santiago Metropolitan
NOT_YET_RECRUITING
China (1)
Local Institution - 0595
Hefei , Anhui
NOT_YET_RECRUITING
Czech Republic (1)
Local Institution - 0489
Prague , Praha 10
NOT_YET_RECRUITING
France (1)
Local Institution - 0202
Marseille , Bouches-du-Rhône
NOT_YET_RECRUITING
Germany (1)
Local Institution - 0591
Erlangen , Bavaria
NOT_YET_RECRUITING
Hungary (1)
Local Institution - 0203
Veszprém
NOT_YET_RECRUITING
India (1)
Local Institution - 0010
Nashik , Dādra and Nagar Haveli and Damān and Diu
NOT_YET_RECRUITING
Italy (1)
Local Institution - 0617
Castellana Grotte , Bari
NOT_YET_RECRUITING
Japan (1)
Local Institution - 0053
Chiba , Chiba
NOT_YET_RECRUITING
Netherlands (1)
Local Institution - 0173
Eindhoven , North Brabant
NOT_YET_RECRUITING
Poland (1)
Local Institution - 0364
Krakow , Lesser Poland Voivodeship
NOT_YET_RECRUITING
Romania (1)
Local Institution - 0282
Cluj-Napoca , Cluj
NOT_YET_RECRUITING
Singapore (1)
Local Institution - 0145
Singapore , Central Singapore
NOT_YET_RECRUITING
South Korea (1)
Local Institution - 0406
Seongnam , Gyeonggido
NOT_YET_RECRUITING
Spain (1)
Local Institution - 0163
Badalona , Barcelona [Barcelona]
NOT_YET_RECRUITING
Sweden (1)
Local Institution - 0074
Stockholm , Stockholm County
NOT_YET_RECRUITING
Taiwan (1)
Local Institution - 0301
Kaohsiung Niao Sung Dist , Kaohsiung
NOT_YET_RECRUITING
Turkey (1)
Local Institution - 0020
Adana
NOT_YET_RECRUITING
United Kingdom (1)
The Christie NHS Foundation Trust
Manchester , Lancashire
United States (1)
Local Institution - 0428
Tucson , Arizona
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
31.12.2025
Completion date
11.03.2034
Registry ID
NCT07221357
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.