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MK-4716 for certain advanced solid tumors

A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors

Phase 1 Interventional Merck Sharp & Dohme LLC · NCT07247110

This trial will test whether the oral drug MK-4716, given alone or with pembrolizumab or cetuximab, is safe and tolerable for people with advanced or metastatic solid tumors that have KRAS gene changes.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsCetuximab, Pembrolizumab, immunotherapy, prednisone
Locations16 sites (New Brunswick, New Jersey and 15 other locations)
Trial IDNCT07247110 on ClinicalTrials.gov

What this trial studies

This Phase 1 dose‑escalation study tests MK-4716 as monotherapy and in combination with pembrolizumab or cetuximab to define safety, tolerability, and a recommended dose. Participants are assigned to arms based on tumor type and prior treatment, with the pembrolizumab arm enrolling untreated metastatic non‑small cell lung cancer and other arms enrolling previously treated KRAS‑altered solid tumors. Primary outcomes include dose‑limiting toxicities, adverse events, and pharmacokinetics, while investigators will also record preliminary anti‑tumor activity. The trial is sponsored by Merck and conducted at three U.S. clinical sites.

Who should consider this trial

Good fit: Ideal candidates are adults with measurable, locally advanced or metastatic solid tumors harboring KRAS alterations—untreated metastatic non‑small cell lung cancer for the pembrolizumab arm or previously treated disease for the dose‑escalation and cetuximab arms—who can take oral medication.

Not a fit: Patients without KRAS alterations, those with significant immunodeficiency or on chronic high‑dose steroids (for the pembrolizumab arm), or those unable to swallow oral medication are unlikely to be eligible or receive benefit.

Why it matters

Potential benefit: If successful, MK-4716 could provide a new targeted treatment option for patients with KRAS‑altered advanced tumors and potentially control disease with manageable side effects.

How similar studies have performed: Other drugs targeting specific KRAS mutations (such as G12C inhibitors) have shown clinical benefit, but MK-4716 and its combinations represent a newer approach with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor
* Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration
* Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease
* Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer
* Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration
* Arm MK-4716 + Pembrolizumab: Must be untreated
* Has measurable disease
* Has the ability to swallow and retain oral medication

Exclusion Criteria:

* Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment
* Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* History of human immunodeficiency virus infection
* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has a known active central nervous system metastases and/or carcinomatous meningitis
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* Has Hepatitis B or Hepatitis C virus infection
* History of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications

Where this trial is running

New Brunswick, New Jersey and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions Malignant Neoplasm
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.