Evaluating MK-6837 for advanced solid tumors
A Phase 1 Open-label, Multicenter Study of MK-6837 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors
PHASE1 · Merck Sharp & Dohme LLC · NCT06460961
This study is testing a new drug called MK-6837, alone and with another treatment, to see if it can help people with advanced solid tumors that haven't improved with standard therapies.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Drugs / interventions | immunotherapy, radiation, pembrolizumab |
| Locations | 6 sites (Morristown, New Jersey and 5 other locations) |
| Trial ID | NCT06460961 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of MK-6837, both as a standalone treatment and in combination with pembrolizumab, for patients with advanced or metastatic solid tumors that have not responded to standard therapies. Participants will be closely monitored for adverse effects and treatment responses. The study does not involve hypothesis testing, focusing instead on gathering data on the drug's performance in this patient population.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically or cytologically confirmed advanced or metastatic solid tumors who have not responded to conventional therapies.
Not a fit: Patients with a history of second malignancies or those who have not recovered from previous treatment-related adverse events may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat advanced solid tumors.
How similar studies have performed: Other studies involving PD-1 and PD-L1 inhibitors have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic * Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on Antiretroviral Therapy (ART) * Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before allocation * Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any Adverse Events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * Has clinically significant cardiovascular disease * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention * Known additional malignancy that is progressing or has required active treatment within the past 2 years * Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Active infection requiring systemic therapy * History of allogeneic tissue/solid organ transplant * Participants who have not adequately recovered from major surgery or have ongoing surgical complications
Where this trial is running
Morristown, New Jersey and 5 other locations
- Atlantic Health System Morristown Medical Center ( Site 4001) — Morristown, New Jersey, United States (RECRUITING)
- Providence Portland Medical Center ( Site 4002) — Portland, Oregon, United States (RECRUITING)
- Westmead Hospital ( Site 1002) — Westmead, New South Wales, Australia (RECRUITING)
- The Alfred Hospital ( Site 1001) — Melbourne, Victoria, Australia (RECRUITING)
- Princess Margaret Cancer Centre ( Site 2001) — Toronto, Ontario, Canada (RECRUITING)
- Sheba Medical Center-ONCOLOGY ( Site 3001) — Ramat Gan, Israel (RECRUITING)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.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.
Conditions: Neoplasm Metastasis, Programmed Cell Death-1, Programmed Cell Death 1 Ligand 1, Programmed Cell Death 1 Ligand 2