Clinical Trial 23967

• Overview

  Study Title:

  ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

  Summary:

  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

  Objective:

  Phase 2 Primary Objective: * To evaluate the OR of pumitamig in combination with FOLFOX/FOLFIRI vs bevacizumab + FOLFOX/FOLFIRI in participants with 1L mCRC. Secondary Objectives: * To further evaluate the efficacy of pumitamig in combination with FOLFOX/FOLFIRI vs bevacizumab + FOLFOX/FOLFIRI in participants with 1L mCRC. * To inform the dose of pumitamig to continue in Phase 3 of the study. Phase 3 Primary Objective: * To compare PFS of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC. Secondary Objectives: * To compare OS of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC. * To further evaluate the efficacy of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC.

• Treatments

  Therapies:

  Bispecific antibody targeting PD-L1 and VEGF-A; Chemotherapy (NOS); Immunotherapy

  Medications:

  5-fluorouracil (); CPT-11 (irinotecan); Camptosar (irinotecan); Oxaliplatin (); Pumitamig / Bevacizumab (); Xeloda (capecitabine); capecitabine (); eloxatin (Oxaliplatin); irinotecan (); leucovorin ()

• Inclusion Criteria

  Key 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

  Key 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.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.