CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 215 enrolled
Drug / intervention
NT-I7 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04332653
NCT04332653Phase 2Completed
CompareCT.gov

An Open-label Phase 1b/2a Study of NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Advanced Solid Tumors

NeoImmuneTech·interventional·Posted Apr 3, 2020·Updated Mar 9, 2026

In Brief

A Phase 2 clinical trial evaluating NT-I7 and pembrolizumab (KEYTRUDA®) for Any Advanced Solid Tumors and 6 related conditions. Completed, enrolled 215 participants across 8 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAny Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer
CountriesUnited States
CollaboratorsMerck Sharp and Dohme LLC, Rahway, NJ, USA

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 3, 2020
Enrollment StartJun 10, 2020
Primary CompletionNov 22, 2024
Study CompletionJan 13, 2025
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 6.2 years ago

Interventions

NT-I7drug

Administered by intramuscular (IM) injection

pembrolizumab (KEYTRUDA®)drug

Administered by intravenous (IV) injection