KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)

Part of paid clinical trials in Clermont, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07252739
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-1084 — DRUG
    Oral Administration
  • Pembrolizumab — BIOLOGICAL
    Intravenous administration
  • Cetuximab — BIOLOGICAL
    Intravenous administration
  • Sacituzumab tirumotecan (sac-TMT) — BIOLOGICAL
    Injection powder for intravenous infusion
  • Rescue medication — DRUG
    Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[Hl\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, and granulocyte colony-stimulating factor (G-CSF). A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

Study Details

Researchers want to learn if using a study medicine called MK-1084 can help treat Non-Small Cell Lung Cancer (NSCLC). MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change. The goal of this study is to learn about the safety of MK-1084 and to learn how many people have the cancer get smaller or go away during the study treatment.

Key Dates

First listed
Nov 28, 2025
Start date
Dec 19, 2025
Status verified
Jul 2026
Primary completion
Jan 14, 2033
Completion
Jan 14, 2033

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A- Pembrolizumab + MK-1084
    Participants receive 400 mg of Pembrolizumab every 6 weeks and MK-1084 dose regimen.
  • Experimental: Arm B- Pembrolizumab + MK-1084 + Cetuximab
    Participants receive 400 mg of Pembrolizumab every 6 weeks, MK-1084 dose regimen, and Cetuximab 500 mg/m\^2 every 2 weeks.
  • Experimental: Arm C- Pembrolizumab + MK-1084 + sacituzumab tirumotecan (sac-TMT)
    Participants receive 400 mg of Pembrolizumab every 6 weeks, MK-1084 dose regimen, and 4 mg/kg sacituzumab tirumotecan (sac-TMT) every 2 weeks.

Primary Outcome Measure

Percentage of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: Up to approximately 21 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Clermont Oncology Center ( Site 0041)ClermontFlorida34711
Study Coordinator
386-538-3169
Sanford Health Roger Maris Cancer Center ( Site 0039)FargoNorth Dakota58102
Study Coordinator
701-234-2000
Sanford Cancer Center Oncology Clinic ( Site 0038)Sioux FallsSouth Dakota57104
Study Coordinator
605-328-8000

Find similar trials in Clermont, FL

By research site
Clermont Oncology Center· Clermont, FLSanford Health Roger Maris Cancer Center· Fargo, NDSanford Cancer Center Oncology Clinic· Sioux Falls, SD

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