A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and in Combination With Pembrolizumab in Subjects With KRASG12C Mutant Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Feb 4, 2026
  • participants needed
    264
  • sponsor
    Merck Sharp & Dohme LLC
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Updated on 21 October 2022
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Summary

This is a study evaluating the efficacy, safety, and pharmacokinetics of MK-1084 in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRASG12C) mutation and MK-1084 plus pembrolizumab in participants with first line (1L) non-small cell lung cancer (NSCLSC) with identified KRASG12C mutation.

Details
Condition Advanced Solid Tumors
Treatment Pembrolizumab, MK-1084
Clinical Study IdentifierNCT05067283
SponsorMerck Sharp & Dohme LLC
Last Modified on21 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

For treatment with MK-1084 - Has locally advanced unresectable or metastatic solid-tumor
malignancy with histologically OR blood-based confirmation of KRASG12C mutation who has
received at least 1 line of therapy for systemic disease
For treatment with pembrolizumab plus MK-1084
Has an untreated metastatic NSCLC with histological OR blood-based confirmation of
KRASG12C mutation and histologic confirmation of tumor proportion score (TPS) ≥1%
For all participants
Has measurable disease by RECIST 1.1 criteria
Has adequate organ function
Male participants must be abstinent from heterosexual intercourse as their preferred
and usual lifestyle (abstinent on a long-term and persistent basis) and agree to
remain abstinent OR must agree to use contraception unless confirmed to be
azoospermic
Female participants must not be pregnant or breastfeeding, and at least one of the
following conditions applies: is not a woman of child-bearing potential (WOCBP); is a
WOCBP and uses a contraceptive method that is highly effective, with low user
dependency, or be abstinent from heterosexual intercourse as their preferred and usual
lifestyle and must have a negative highly sensitive pregnancy test within 24 hours
before the first dose of study intervention

Exclusion Criteria

Has received chemotherapy, definitive radiation, or biological cancer therapy within 4
weeks (2 weeks for palliative radiation)
Has a history of second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 5 years
Has clinically active central nervous system (CNS) metastases and/or carcinomatous
meningitis
Has an active infection requiring systemic therapy
Has a history of human immunodeficiency virus (HIV) and/or hepatitis B or C
infections
Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has a history of interstitial lung disease, noninfectious pneumonitis requiring active
steroid therapy, or ongoing pneumonitis
Has an active autoimmune disease requiring systemic therapy
Has not fully recovered from any effects of major surgical procedure without
significant detectable infection
Has one or more of the following ophthalmological findings/conditions: intraocular
pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous
retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of
retinal degenerative disease
Has received live or live-attenuated vaccine within 4 weeks of study start
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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