Study #2020-0008
An Open-label Phase 1b/2a Study of NT-I7 (efineptakin alfa) in Combination with Pembrolizumab in Subjects with Relapsed/ Refractory Advanced Solid Tumors
MD Anderson Study Status
Not Accepting
Treatment Agent
NT-I7, pembrolizumab (KEYTRUDA®)
Description
The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors: * Safety and tolerability of NT-I7 in combination with pembrolizumab * Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) The main purpose of Phase 2a of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with pembrolizumab in participants with checkpoint inhibitor (CPI) treated and naïve relapsed and refractory (R/R) tumors. The main purpose of the Biomarker Cohort is to assess a potential correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits in participants with CPI-naïve R/R ovarian cancer (OC).
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Any Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer
Study phase:
Physician name:
Aung Naing
Department:
Investigational Cancer Therapeutics
For general questions about clinical trials:
1-833-802-0471
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