Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04305041 · ClinicalTrials.gov registry record · Phase 1
Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)
A Phase 1 study of Melanoma, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT04305041: Completed Phase 1 study of Melanoma, sponsored by Merck Sharp & Dohme.
NCT04305041 is a Phase 1 study of Melanoma that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 100 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305041, a Phase 1 study of Melanoma, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE is reported.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG ATRA
- DRUG Lenvatinib
- BIOLOGICAL Vibostolimab
- BIOLOGICAL Quavonlimab
Study Locations (20)
California
- The Angeles Clinic and Research Institute ( Site 1009) - Los Angeles
- UCLA Hematology & Oncology ( Site 1004) - Los Angeles
- Providence Saint John's Health Center ( Site 1010) - Santa Monica
New South Wales
- Calvary Mater Newcastle-Medical Oncology ( Site 1404) - Waratah
- Melanoma Institute Australia ( Site 1402) - Wollstonecraft
Colorado
- University of Colorado, Anschutz Cancer Pavilion ( Site 1012) - Aurora
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022) - Baltimore
New York
- NYU Clinical Cancer Center ( Site 1002) - New York
North Carolina
- Duke Cancer Institute ( Site 1005) - Durham
Ohio
- Martha Morehouse Tower ( Site 1020) - Columbus
Oregon
- Oregon Health & Science University ( Site 1013) - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-06-26 |
| Est. Completion | 2025-08-25 |
| Phase | Phase 1 |
What the finished NCT04305041 record still lists
NCT04305041 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04305041 names 20 study sites across 17 states, led by California, New South Wales, Colorado.
Frequently Asked Questions
What is clinical trial NCT04305041 about?
NCT04305041 is a clinical study titled "Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)". Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory...
What is the current status of trial NCT04305041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2020-06-26. Estimated completion is 2025-08-25.
What conditions does trial NCT04305041 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT04305041?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), ATRA (DRUG), Lenvatinib (DRUG), Vibostolimab (BIOLOGICAL), Quavonlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04305041?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305041 being conducted?
This trial has 20 study locations across California, Colorado, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04305041's enrollment target sits among peer trials
100 109th of 266 higher than 155 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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
-
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
RECRUITING · Phase 1
-
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
RECRUITING · Phase 1
-
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
RECRUITING · Phase 1
-
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI