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A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)

NCT03918278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2025-06-25

No results posted yet for this 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.

Conditions

  • Neoplasms

Interventions

BIOLOGICAL

MK-0482

IV infusion

BIOLOGICAL

pembrolizumab

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Nab-paclitaxel

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Pemetrexed

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2025-06-09
Completion
2025-06-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Israel
  • Italy
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918278 on ClinicalTrials.gov