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

Purpose

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.

Condition

  • Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit. - 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

  • Participant is not eligible for study treatment per the parent study eligibility criteria. - 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. - Participants not receiving clinical benefit from parent study drug as assessed by the investigator. Other protocol defined inclusion/exclusion criteria applies.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A1
  • Drug: Adagrasib
    Specified dose on specified days
    Other names:
    • BMS-986503
Experimental
Arm A2
  • Drug: Adagrasib
    Specified dose on specified days
    Other names:
    • BMS-986503
Experimental
Arm B1
  • Drug: Adagrasib
    Specified dose on specified days
    Other names:
    • BMS-986503
  • Drug: Pembrolizumab
    Specified dose on specified days
Experimental
Arm B2
  • Drug: Adagrasib
    Specified dose on specified days
    Other names:
    • BMS-986503
  • Drug: Pembrolizumab
    Specified dose on specified days
Experimental
Arm B3
  • Drug: Adagrasib
    Specified dose on specified days
    Other names:
    • BMS-986503
  • Drug: Cetuximab
    Specified dose on specified days
Experimental
Arm B4
  • Drug: Adagrasib
    Specified dose on specified days
    Other names:
    • BMS-986503
  • Drug: Pembrolizumab
    Specified dose on specified days
  • Drug: Pemetrexed
    Specified dose on specified days
Experimental
Arm C1
  • Drug: Pembrolizumab
    Specified dose on specified days
Experimental
Arm C2
  • Drug: Docetaxel
    Specified dose on specified days
Experimental
Arm C3
  • Drug: Irinotecan
    Specified dose on specified days
  • Drug: Leucovorin
    Specified dose on specified days
    Other names:
    • Folinic acid
  • Drug: Fluorouracil
    Specified dose on specified days
Experimental
Arm C4
  • Drug: Leucovorin
    Specified dose on specified days
    Other names:
    • Folinic acid
  • Drug: Oxaliplatin
    Specified dose on specified days
  • Drug: Fluorouracil
    Specified dose on specified days

Recruiting Locations

Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
Contact:
Konstantinos Leventakos, Site 0017
507-284-2511

More Details

Status
Recruiting
Sponsor
Mirati Therapeutics Inc.

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com