NCT02452424

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Melanoma
• Non-small Cell Lung Cancer
• Squamous Cell Carcinoma of the Head and Neck
• Gastrointestinal Stromal Tumor (GIST)
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	PLX3397	PLX3397 capsules, 200 mg
BIOLOGICAL	Pembrolizumab	Pembrolizumab, 200 mg, IV

Timeline

• Start date: 2015-07-02
• Primary completion: 2018-08-17
• Completion: 2018-10-12
• First posted: 2015-05-22
• Last updated: 2020-03-05
• Results posted: 2019-10-09

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study