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 10 tumor types: - Advanced melanoma: anti-PD-1/PD-L1 naïve and CSF1R inhibitor naïve - 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 - Triple-negative breast cancer - Squamous cell carcinoma of the head and neck - Bladder cancer - Pancreatic ductal adenocarcinoma - Gastric cancer
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
Melanoma Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck GIST Pembrolizumab
Open to people ages 18 years and up
A subject must satisfy all of the following criteria to be considered for inclusion in the study:
A subject who meets any of the following criteria will be disqualified from entering the study:
Has known central nervous system metastases and/or carcinomatous meningitis.
o Note: Subjects with previously treated brain metastases may participate if they meet the following criteria: 1) are stable for at least 28 days prior to the first dose of study treatment and if all neurologic symptoms returned to baseline); 2) have no evidence of new or enlarging brain metastases; and 3) have not been using steroids for at least 7 days prior to first dose of study treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02452424.
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