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A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors

NCT02452424 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-03-05

Study results available
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Summary

The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work together to affect cancer cells.

PLX3397 is designed to target the receptor for CSF1 (CSF1R). Pembrolizumab is designed to block the interaction between the receptor PD-1 and molecules that bind PD-1. In this study, PLX3397 and pembrolizumab are being given together in order to study their combined effects on patients' immune responses to their tumors. Tumor-specific immune responses have been shown to kill cancer cells and/or to stop tumors from growing.

Part 1 of the study (dose-escalation phase) will establish the safest dose of PLX3397 to be given in combination with pembrolizumab. Part 2 of the study (expansion phase) will include an evaluation of efficacy of this combination in the following tumor types:

* Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded
* Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as defined by irRECIST while on therapy
* Non-small cell lung cancer
* Ovarian cancer
* Gastrointestinal Stromal Tumor (GIST)
* Squamous cell cancer of the head and neck

Conditions

Interventions

DRUG

PLX3397

PLX3397 capsules, 200 mg

BIOLOGICAL

Pembrolizumab

Pembrolizumab, 200 mg, IV

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-02
Primary Completion
2018-08-17
Completion
2018-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT02452424 on ClinicalTrials.gov