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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

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Trial Identification

Brief Title: Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in NSCLC With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer

Official Title: A Phase 1b/2, Open-label, Dose Escalation Study of Entinostat in Combination With Pembrolizumab in Patients With Non-small Cell Lung Cancer, With Expansion Cohorts in Patients With Non-small Cell Lung Cancer, Melanoma, and Mismatch Repair-Proficient Colorectal Cancer

Study ID: NCT02437136

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

Yale University, New Haven, Connecticut, United States

Emory University, Atlanta, Georgia, United States

University of Maryland, Marlene and Stewart Greenbaum Cancer Center, Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Dana Farber Cancer Institution, Boston, Massachusetts, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

St Luke's University Health Network, Easton, Pennsylvania, United States

Sarah Cannon Research Institute, Nashville, Tennessee, United States

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Contact Details

Name: Passi A Janne, MD, PhD

Affiliation: Dana-Farber Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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