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Study to Evaluate SOC Chemo and Bevacizumab w/ or w/o INCA33890 in 1st line tx of MSS mCRC Cancer

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.

Details

Full study title A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
Protocol number OCR49605
ClinicalTrials.gov ID NCT07284849
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Stage IV colorectal adenocarcinoma not amenable to curative resection.

  • No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.

  • Measurable disease per RECIST v1.1.

  • ECOG performance status of 0 or 1.

  • Adequate organ function determined by laboratory results.

Exclusion Criteria:

  • MSI-H/dMMR per historical data in the medical record.

  • BRAF V600E mutation per historical data in the medical record.

  • Untreated and/or progressing CNS metastases.

  • History of other malignancy within 2 years.

  • Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.

  • Active autoimmune disease that has required systemic treatment in the past 2 years.

  • Significant concurrent and/or uncontrolled medical condition.

  • History of organ transplant, including allogeneic stem cell transplantation.

Other protocol-defined inclusion/exclusion criteria apply.

Lead researcher

  • Mina Shenouda, MD
    Cancer Specialist (Oncologist), Hematology and Oncology Specialist, Oncologist (Cancer Specialist)
    Languages: Arabic

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  2. Step
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    Get screened to confirm eligibility

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