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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 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 470 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03564691
The ClinicalTrials.gov registry entry for NCT03564691 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 470 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03564691 reports 0 study locations.
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.
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