MedTrace Logo

Study of Epacadostat (INCB024360) Alone and In Combination With Pembrolizumab (MK-3475) With Chemotherapy and Pembrolizumab Without Chemotherapy in Participants With Advanced Solid Tumors (MK-3475-434)

NCT02862457 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-08-19

Study results available
· View outcomes & findings →

Summary

This is an open-label, non-randomized, Phase I study of epacadostat (INCB024360) alone and in combination with pembrolizumab with chemotherapy and pembrolizumab without chemotherapy in participants with advanced solid tumors. The primary objective of the trial is to evaluate the safety and tolerability of epacadostat administered alone and in combination with pembrolizumab with and without chemotherapy.

With protocol amendment 02 (26-April-2019), treatment with epacadostat was stopped in the "Epacad+Pembro+Cisplatin+Pemetrexed", "Epacad+Pembro+Carboplatin+Pemetrexed", and "Epacad+Pembro+Carboplatin+Paclitaxel" study arms.

Conditions

  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Epacadostat 25 mg

Oral administration

DRUG

Epacadostat 100 mg

Oral administration

BIOLOGICAL

pembrolizumab 200 mg

Intravenous (IV) infusion

DRUG

Cisplatin 75 mg/m^2

IV infusion

DRUG

Carboplatin Area Under the Curve (AUC) 5

IV infusion

DRUG

Pemetrexed 500 mg/m^2

IV infusion

DRUG

Paclitaxel 200 mg/m^2

IV infusion

DRUG

Carboplatin AUC 6

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-23
Primary Completion
2020-11-20
Completion
2020-11-20

More Related Trials

Entities

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 NCT02862457 on ClinicalTrials.gov