Spots Global Cancer Trial Database for Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in NSCLC With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer

Study Description

Brief Summary: The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally, the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer

Detailed Description: SNDX-275-0601 is an open-label, Phase 1b/2 study evaluating the combination of entinostat plus pembrolizumab in patients with advanced metastatic or recurrent NSCLC or melanoma or mismatch repair-proficient colorectal cancer. The study has 2 phases, a Dose Escalation/Confirmation Phase (Phase 1b) and an Expansion Phase (Phase 2). An additional cohort (Entinostat Monotherapy Immune Correlate \[EMIC\] Cohort) evaluating single agent entinostat for 2 weeks followed by the combination will also be evaluated in patients with NSCLC in the Phase 2 expansion phase. Toxicities will be assessed by the Investigator using the United States (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Dose Confirmation: The prospective MTD/RP2D identified in the Dose Escalation Phase will be confirmed in 9 patients in Dose Confirmation Cohort(s) to obtain additional AE, immune correlate, and anti-tumor activity data on entinostat in combination. Phase 2 (Expansion): In the Expansion Phase, entinostat in combination will be evaluated using the RP2D identified in the Dose Escalation/Confirmation Phase. Up to 3 Expansion Cohorts consisting of distinct subsets of patients with solid tumor cancers may be explored. Expansion cohorts may include: 1. Cohort 1: NSCLC 2. Cohort 2: Patients with NSCLC (any histology) who have previously been treated and responded and then progressed on either a PD-1 or PD-L1-blocking antibody 3. Cohort 3: Patients with melanoma who have previously been treated with and unequivocally progressed on either a PD-1 or PD-L1-blocking antibody 4. Cohort 4: Patients with CRC (mismatch repair-proficient) who have not been previously treated with a PD-1 or PD-L1 blocking antibody EMIC Cohort: 15 NSCLC patients Stage 2 of Cohort 1 will be randomly assigned to participate.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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