Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)
Public ClinicalTrials.gov record NCT03564691. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03564691
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 470 participants
Conditions and interventions
Conditions
Interventions
- MK-4830 Drug
- Pembrolizumab Drug
- Carboplatin Drug
- Pemetrexed Drug
- Lenvatinib Drug
- Paclitaxel Drug
- Cisplatin Drug
- MK-4830A Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 11, 2018 (Actual)
- Primary completion
- Sep 26, 2025 (Actual)
- Completion
- Sep 26, 2025 (Actual)
- Last update posted
- Oct 7, 2025
2018 – 2025
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at San Francisco ( Site 0004) | San Francisco | California | 94158 | — |
| Henry Ford Health System ( Site 0002) | Detroit | Michigan | 48202 | — |
| Washington University ( Site 0003) | St Louis | Missouri | 63110 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005) | Hackensack | New Jersey | 07601 | — |
| Laura and Isaac Perlmutter Cancer Center ( Site 0008) | New York | New York | 10016 | — |
| Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 00 | Columbus | Ohio | 43210 | — |
| South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001) | San Antonio | Texas | 78229 | — |
| Utah Cancer Specialists ( Site 0011) | Salt Lake City | Utah | 84106 | — |
| Seattle Cancer Care Alliance ( Site 0010) | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03564691, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2025 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03564691 live on ClinicalTrials.gov.