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ID del estudio CA266-0003  |   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

Ícono de advertencia
Lo sentimos, este estudio aún no acepta participantes.
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Resumen

  • Phase 2/Phase 3
  • Ícono de género masculino y femenino
  • 18+
  • 113
  • Ícono de BMS, estudio No reclutando aún
    Not Yet Recruiting

Descripción general

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

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
  • Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
    1. 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).
      1. Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
        1. Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

          Criterios de exclusión

          Criterios de exclusión Icon
          • Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
            1. 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.
              1. 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.
                1. 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.
                  Información Adicional *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Opciones de tratamiento

                    Brazos del estudio

                    INTERVENCIÓN ASIGNADA

                    Brazos del estudio

                    Experimental: Arm A1

                    INTERVENCIÓN ASIGNADA
                    • Drug: Pumitamig, FOLFOX, FOLFIRI

                    Brazos del estudio

                    Experimental: Arm A2

                    INTERVENCIÓN ASIGNADA
                    • Drug: Pumitamig, FOLFOX, FOLFIRI

                    Brazos del estudio

                    Other: Arm B

                    INTERVENCIÓN ASIGNADA
                    • Drug: FOLFOX, FOLFIRI, Bevacizumab

                    Brazos del estudio

                    Experimental: Arm C

                    INTERVENCIÓN ASIGNADA
                    • Drug: Pumitamig, FOLFOX, FOLFIRI, CAPOX

                    Brazos del estudio

                    Other: Arm D

                    INTERVENCIÓN ASIGNADA
                    • Drug: FOLFOX, FOLFIRI, Bevacizumab, CAPOX
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