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NCT03564691 · ClinicalTrials.gov registry record · Phase 1
Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 470
- Enrollment target
NCT03564691: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT03564691 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 470 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (683% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03564691, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 470 participants
- Enrollment target
Study Summary
This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combination with pembrolizumab (Arm C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab (Arms A-F); evaluate the safety and tolerability of MK-4830 administered in combination with pembrolizumab, carboplatin, and pemetrexed (Arm G) and of MK-4830 administered in combination with pembrolizumab and lenvatinib (Arm H); evaluate the safety, tolerability and ORR of MK-4830 in combination with pembrolizumab plus chemotherapy (Arms I-L); and evaluate the safety and tolerability of MK-4830 in combination with pembrolizumab in Chinese participants from China (Arm M). The coformulation part (Arm N) evaluates the safety and tolerability of MK-4830A (coformulation of MK-4830 800 mg + pembrolizumab 200 mg). There is no formal hypothesis testing in this study.
Primary Outcome
The occurrence of the following toxicities, if assessed by the investigator to be possibly, probably, or definitely related to study treatment administration: * Grade 4 nonhematologic toxicity (not laboratory) * Grade 4 hematologic toxicity lasting \>=7 days, except thrombocytopenia: * Any nonhematologic AE \>=Grade 3 in severity, with exceptions * Any Grade 3 or Grade 4 alanine aminotransferase, aspartate aminotransferase, and/or bilirubin laboratory value * Any other nonhematologic laboratory
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Lenvatinib
- DRUG MK-4830
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2018-07-11 |
| Est. Completion | 2025-09-26 |
| Phase | Phase 1 |
What the finished NCT03564691 record still lists
NCT03564691 is an interventional study that assigns participants to a tested intervention. The registered 470 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (683% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03564691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03564691 about?
NCT03564691 is a clinical study titled "Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)". This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combinatio...
What is the current status of trial NCT03564691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 470 participants. The study started on 2018-07-11. Estimated completion is 2025-09-26.
What interventions are being tested in trial NCT03564691?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Pemetrexed (DRUG), Lenvatinib (DRUG), MK-4830 (DRUG).
Who is sponsoring clinical trial NCT03564691?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03564691's enrollment target sits among peer trials
470 52nd of 2000 higher than 1,949 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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