MK-4716 for certain advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rutgers Cancer Institute of New Jersey ( Site 0052)
  New Brunswick, New Jersey, United States Recruiting
• NEXT Oncology ( Site 0051)
  Irving, Texas, United States Recruiting
• NEXT Virginia ( Site 0054)
  Fairfax, Virginia, United States Recruiting
• Blacktown Hospital ( Site 0455)
  Sydney, New South Wales, Australia Recruiting
• Monash Health ( Site 0452)
  Clayton, Victoria, Australia Recruiting
• The Alfred Hospital ( Site 0453)
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.