Testing MK-4700 alone or with Pembrolizumab for advanced cancers
A Phase 1 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-4700 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
This study is testing a new cancer treatment called MK-4700, both by itself and with another drug called pembrolizumab, to see how well it works and how safe it is for people with advanced cancers that haven’t responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 3 sites (Haifa and 2 other locations) |
| Trial ID | NCT06894771 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and tolerability of different doses of MK-4700, both alone and in combination with pembrolizumab, in patients with advanced or metastatic solid tumors. Participants will be monitored over time to assess how their bodies respond to the treatment. The study focuses on patients who have experienced disease progression after prior cancer therapies or who have not been able to tolerate them. The goal is to identify a safe and effective dose for treating specific types of cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors who have not responded to or cannot tolerate previous treatments.
Not a fit: Patients with progressing additional malignancies or those with specific HIV-related complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers that have limited effective therapies.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but the specific combination of MK-4700 and pembrolizumab is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report who have experienced disease progression on or after prior anti-cancer treatments, or been intolerant to, or refused all treatment known to confer clinical benefit * Has head and neck squamous cell carcinoma (HNSCC), melanoma (cutaneous), non-small cell lung cancer (NSCLC), cervical cancer, triple negative breast cancer (TNBC), urothelial carcinoma (UC), or renal cell carcinoma (RCC; clear cell, papillary) * If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART) * Has normal cardiac function Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * If HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has known additional malignancy that is progressing or has required active treatment within the past 2 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids * Has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus infection * Has had an allogeneic tissue/solid organ transplant in the last 5 years
Where this trial is running
Haifa and 2 other locations
- Rambam Health Care Campus ( Site 0201) — Haifa, Israel (Recruiting)
- Rabin Medical Center ( Site 0202) — Petah Tikva, Israel (Recruiting)
- Sheba Medical Center ( Site 0200) — Ramat Gan, Israel (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@merck.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.