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NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT04332653 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG NT-I7
- DRUG pembrolizumab (KEYTRUDA®)
Study Locations (8)
Texas
- Mary Crowley Cancer Research — Dallas
- MD Anderson Cancer Center — Houston
Florida
- Moffit Cancer Center — Tampa
Michigan
- Barbara Ann Karmanos Cancer Institute — Detroit
Missouri
- Washington University School of Medicine in St. Louis — St Louis
North Carolina
- Duke University Medical Center — Durham
Pennsylvania
- Fox Chase Cancer Center — Philadelphia
Tennessee
- Sarah Cannon Research Institute — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2020-06-10 |
| Est. Completion | 2025-01-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04332653
The ClinicalTrials.gov registry entry for NCT04332653 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeoImmuneTech, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions — of which NT-I7 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04332653 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Texas, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04332653 about?
NCT04332653 is a clinical study titled "NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors". 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...
What is the current status of trial NCT04332653?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 215 participants. The study started on 2020-06-10. Estimated completion is 2025-01-13.
What conditions does trial NCT04332653 study?
This clinical trial studies the following conditions: Ovarian Cancer, Pancreatic Cancer, Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04332653?
The interventions under investigation include: NT-I7 (DRUG), pembrolizumab (KEYTRUDA®) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04332653?
This trial is sponsored by NeoImmuneTech, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04332653 being conducted?
This trial has 8 study locations across Florida, Michigan, Missouri, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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