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Terminated Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT02452424

Public ClinicalTrials.gov record NCT02452424. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 1/2a Study of Double-Immune Suppression Blockade By Combining a CSF1R Inhibitor (PLX3397) With An Anti-PD-1 Antibody (Pembrolizumab) To Treat Advanced Melanoma And Other Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT02452424
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
78 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2, 2015 (Actual)
Primary completion
Aug 17, 2018 (Actual)
Completion
Oct 12, 2018 (Actual)
Last update posted
Mar 5, 2020

2015 – 2018

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
HonorHealth Research Institute Scottsdale Arizona 85258 —
Marin Cancer Care Greenbrae California 94904 —
Ronald Reagan UCLA Medical Center Los Angeles California 90095 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02115 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
Karmanos Cancer Institute Detroit Michigan 48201 —
Washington University St. Louis Siteman Cancer Center St Louis Missouri 63130 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
Medical University Health Hollings Cancer Center Charleston South Carolina 29425 —
Vanderbilt Ingram Cancer Center Nashville Tennessee 37212 —
South Texas Accelerated Research Therapeutics San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02452424, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 5, 2020 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02452424 live on ClinicalTrials.gov.

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