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Trial ID CA239-0071  |   NCT07415031

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 45
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit.
    1. Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.

      Exclusion Criteria

      Exclusion Criteria Icon
      :
      • Participant is not eligible for study treatment per the parent study eligibility criteria.
        1. Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study.
          1. Participants not receiving clinical benefit from parent study drug as assessed by the investigator. Other protocol defined inclusion/exclusion criteria applies.
            Additional Information *

            Treatment Options

            Study Arms

            ASSIGNED INTERVENTION

            Study Arms

            Experimental: Arm A1

            ASSIGNED INTERVENTION
            • Drug: Adagrasib

            Study Arms

            Experimental: Arm A2

            ASSIGNED INTERVENTION
            • Drug: Adagrasib

            Study Arms

            Experimental: Arm B1

            ASSIGNED INTERVENTION
            • Drug: Adagrasib, Pembrolizumab

            Study Arms

            Experimental: Arm B2

            ASSIGNED INTERVENTION
            • Drug: Adagrasib, Pembrolizumab

            Study Arms

            Experimental: Arm B3

            ASSIGNED INTERVENTION
            • Drug: Adagrasib, Cetuximab

            Study Arms

            Experimental: Arm B4

            ASSIGNED INTERVENTION
            • Drug: Adagrasib, Pembrolizumab, Pemetrexed

            Study Arms

            Experimental: Arm C1

            ASSIGNED INTERVENTION
            • Drug: Pembrolizumab

            Study Arms

            Experimental: Arm C2

            ASSIGNED INTERVENTION
            • Drug: Docetaxel

            Study Arms

            Experimental: Arm C3

            ASSIGNED INTERVENTION
            • Drug: Irinotecan, Leucovorin, Fluorouracil

            Study Arms

            Experimental: Arm C4

            ASSIGNED INTERVENTION
            • Drug: Leucovorin, Oxaliplatin, Fluorouracil
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