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NCT06460961 · ClinicalTrials.gov registry record · Phase 1
A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)
A Phase 1 study of Neoplasm Metastasis, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 1
- Development phase
- 168
- Enrollment target
- 7
- Study locations
NCT06460961: Active Phase 1 study of Neoplasm Metastasis, sponsored by Merck Sharp & Dohme.
NCT06460961 is a Phase 1 study of Neoplasm Metastasis that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 168 participants, below the 412-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (59% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06460961, a Phase 1 study of Neoplasm Metastasis, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 168 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of MK-6837, administered as a monotherapy and in combination with pembrolizumab (MK-3475), in participants with histologically or cytologically confirmed advanced/metastatic solid tumors that have not responded to conventional therapy. There will not be any hypothesis testing in the study. As of Amendment 04 (effective date: 18-Dec-2025), there are no pharmacokinetic (PK) secondary outcome measures in this study.
Primary Outcome
The following events will be considered a DLT unless clearly due to underlying disease or extraneous causes: Grade 4 neutropenia lasting \>7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding, regardless of duration; All Grade 3 or higher nonhematologic toxicities (with exceptions); Any abnormality that results in a drug induced liver injury; Febrile neutropenia Grade 3 or 4; Prolonged delay (\>2 weeks) in initiating treatment after the first 21 days due to
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Rescue Medications
- BIOLOGICAL MK-6837
Study Locations (7)
New Jersey
- Atlantic Health System Morristown Medical Center ( Site 4001) - Morristown
Oregon
- Providence Portland Medical Center ( Site 4002) - Portland
Texas
- South Texas Accelerated Research Therapeutics (START) ( Site 4003) - San Antonio
New South Wales
- Westmead Hospital ( Site 1002) - Westmead
Victoria
- The Alfred Hospital ( Site 1001) - Melbourne
Ontario
- Princess Margaret Cancer Centre ( Site 2001) - Toronto
Other
- Sheba Medical Center-ONCOLOGY ( Site 3001) - Ramat Gan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2024-07-14 |
| Est. Completion | 2027-07-13 |
| Phase | Phase 1 |
What the registry record for NCT06460961 still lists
NCT06460961 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 412-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Neoplasm Metastasis appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06460961 lists 7 locations in 7 states (New Jersey, Oregon, Texas).
Frequently Asked Questions
What is clinical trial NCT06460961 about?
NCT06460961 is a clinical study titled "A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)". The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of MK-6837, administered as a monotherapy and in combination with pembrolizumab (MK-3475), in participants with histologically or cytologically confirmed advanced/metastatic solid tumors that have not respond...
What is the current status of trial NCT06460961?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 168 participants. The study started on 2024-07-14. Estimated completion is 2027-07-13.
What conditions does trial NCT06460961 study?
This clinical trial studies the following conditions: Neoplasm Metastasis.
What interventions are being tested in trial NCT06460961?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Rescue Medications (DRUG), MK-6837 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06460961?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06460961 being conducted?
This trial has 7 study locations across New Jersey, Oregon, Texas, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06460961's enrollment target sits among peer trials
168 19th of 41 higher than 23 of 41 other Neoplasm Metastasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasm Metastasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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