Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03918278 · ClinicalTrials.gov registry record · Phase 1
A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 222
- Enrollment target
NCT03918278: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT03918278 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 222 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (270% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03918278, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 222 participants
- Enrollment target
Study Summary
This is a 2 part study. Part 1 is a dose escalation to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) dose of MK-0482 administered as monotherapy and in combination with pembrolizumab (MK-3475) in participants with advanced solid tumors for which there is no available therapy which may convey clinical benefit. Part 2 is expansion cohort to determine safety and tolerability of MK-0482 in combination with pembrolizumab with and without chemotherapy in participants with advanced tumor specific cohorts.
Primary Outcome
DLTs defined as any of the following assessed as treatment (Tx)-related by investigator: Grade (Gr)4 nonhematologic toxicity (T); Gr4 hematologic T lasting ≥7 days, except thrombocytopenia (TCP); Gr4 TCP of any duration; Gr3 TCP associated with clinically-significant bleeding; nonhematologic adverse event (AE) ≥Gr3 in severity, with exceptions; Gr3/4 alanine transaminase (ALT), aspartate transaminase (AST), and/or bilirubin (bili) with exceptions; a protocol-defined elevation of ALT, AST, and bi
Interventions
- DRUG Paclitaxel
- DRUG Gemcitabine
- BIOLOGICAL pembrolizumab
- DRUG Nab-paclitaxel
- BIOLOGICAL MK-0482
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2019-06-19 |
| Est. Completion | 2025-06-09 |
| Phase | Phase 1 |
What the finished NCT03918278 record still lists
NCT03918278 is an interventional study that assigns participants to a tested intervention. The registered 222 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 (270% higher).
The record links to 0 conditions, and to 5 interventions - of which Paclitaxel is the first listed.
NCT03918278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03918278 about?
NCT03918278 is a clinical study titled "A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)". This is a 2 part study. Part 1 is a dose escalation to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) dose of MK-0482 administered as monotherapy and in combination with pembrolizumab (MK-3475) in participants with advanced solid tumors for which...
What is the current status of trial NCT03918278?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 222 participants. The study started on 2019-06-19. Estimated completion is 2025-06-09.
What interventions are being tested in trial NCT03918278?
The interventions under investigation include: Paclitaxel (DRUG), Gemcitabine (DRUG), pembrolizumab (BIOLOGICAL), Nab-paclitaxel (DRUG), MK-0482 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03918278?
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 NCT03918278's enrollment target sits among peer trials
222 229th of 2000 higher than 1,771 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
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
- NCT04939610 · 222 participants · Phase 1
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
- NCT05424783 · 222 participants
MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)
- NCT05568264 · 222 participants · NA
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
- NCT05605574 · 222 participants · NA
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
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