NT-I7 (Efineptakin Alfa) In Combination With Pembrolizumab In Participants With Advanced Solid Tumors

Study Overview

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 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).

This is a multicenter, open-label Phase 1b/2a study of NT-I7 in combination with pembrolizumab. The study consists of a dose escalation phase (Phase 1b) followed by a dose expansion phase (Phase 2a) and a Biomarker Cohort. The Phase 1b is designed to assess the safety and tolerability, including determination of the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7. The main purpose of Phase 2a of this study is to assess the preliminary antitumor activity of NT-I7 in combination with pembrolizumab in participants with relapsed/refractory * checkpoint inhibitor (CPI)-treated Triple Negative Breast Cancer (TNBC), Non-small Cell Lung Cancer (NSCLC), and Small Cell Lung Cancer (SCLC) * checkpoint inhibitor (CPI)-naïve Microsatellite Stable Colorectal Cancer (MSS-CRC), and Pancreatic Cancer (PC) The Biomarker Cohort is designed to assess the correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits of NT-I7 in combination with pembrolizumab in participants with CPI naïve R/R Ovarian Cancer (OC).

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

DRUG: NT-I7
DRUG: pembrolizumab (KEYTRUDA®)

NIT-110
MK-3475-A60 (OTHER Identifier) (OTHER: Merck Sharp & Dohme LLC)
KEYNOTE-A60 (OTHER Identifier) (OTHER: Merck Sharp & Dohme LLC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-03-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-22
First Submitted that Met QC Criteria 2020-04-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-25
First Posted (ACTUAL) 2020-04-03	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 1b: NT-I7 Dose Escalation NT-I7 will be administered on Day 1 of alternate 21 day cycles (Cycle 1, 3, 5 etc.). Dosage will increase until the maximum tolerated dose (MTD) and/or the recommended phase 2 (RP2D) dose is reached. Pembrolizumab will be administered on Day 1 of every 2	DRUG: NT-I7 Administered by intramuscular (IM) injection DRUG: pembrolizumab (KEYTRUDA®) Administered by intravenous (IV) injection
EXPERIMENTAL: Phase 2a: CPI Treated Triple Negative Breast Cancer Participants with checkpoint inhibitor (CPI) treated relapsed or refractory triple negative breast cancer (TNBC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of eve
EXPERIMENTAL: Phase 2a: CPI Treated Non-small Cell Lung Cancer Participants with checkpoint inhibitor (CPI) treated relapsed or refractory non-small cell lung cancer (NSCLC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of every
EXPERIMENTAL: Phase 2a: CPI Treated Small Cell Lung Cancer Participants with checkpoint inhibitor (CPI) treated relapsed or refractory small cell lung cancer (SCLC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of every 21 d
EXPERIMENTAL: Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory microsatellite stable colorectal cancer (MSS-CRC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on D	DRUG: NT-I7 Administered by intramuscular (IM) injection DRUG: pembrolizumab (KEYTRUDA®) Administered by intravenous (IV) injection
EXPERIMENTAL: Phase 2a: CPI Naïve Pancreatic Cancer Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory pancreatic cancer (PC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of every 21 day cycle.	DRUG: NT-I7 Administered by intramuscular (IM) injection DRUG: pembrolizumab (KEYTRUDA®) Administered by intravenous (IV) injection
EXPERIMENTAL: Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Expansion Cohort Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory microsatellite stable colorectal cancer (MSS-CRC). Participants will receive 1200 µg/kg of NT-I7 and and a fixed dose of 200 mg of pemprolizumab. Pembrolizumab will be administered	DRUG: NT-I7 Administered by intramuscular (IM) injection DRUG: pembrolizumab (KEYTRUDA®) Administered by intravenous (IV) injection
EXPERIMENTAL: Phase 2a: CPI Naïve Pancreatic Cancer, Expansion Cohort Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory pancreatic cancer (PC).Participants will receive 1200 µg/kg of NT-I7 and a fixed dose of 200 mg of pemprolizumab. Pembrolizumab will be administered on Day 1 of every 21 day cycle.
EXPERIMENTAL: Biomarker Cohort: CPI Naïve Ovarian Cancer Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory ovarian cancer (OC). Participants will receive a starting dose of 960 µg/kg of NT-I7 and a fixed dose of 200 mg of pemprolizumab. Pembrolizumab will be administered on Day 1 of eve	DRUG: NT-I7 Administered by intramuscular (IM) injection DRUG: pembrolizumab (KEYTRUDA®) Administered by intravenous (IV) injection

Primary Outcome Measures	Measure Description	Time Frame
Phase 1b: Safety and Tolerability of NT-I7 in Combination With Pembrolizumab to Determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7	* Incidence, nature and severity of Adverse Events (AEs) graded according to NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 * Incidence and nature of Dose-Limiting Toxicities (DLTs)	Up to 2 years
Phase 1b: Safety and Tolerability of NT-I7 in Combination With Pembrolizumab to Determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7	Statistical correlation of dose levels with safety and efficacy parameters.	Up to 2 years
Phase 2a: Preliminary Assessment of the Objective Response Rate (ORR) of NT-I7 in Combination with Pembrolizumab		Up to 2 years
Biomarker Cohort: Number of Tumor-Infiltrating Lymphocytes (TILs)		Up to 2 years
Biomarker Cohort: Distribution of Tumor-Infiltrating Lymphocytes (TILs)	TILs in tumor biopsy samples will be identified using a multi-spectral Immunofluorescence (IF) assay.	Up to 2 years
Biomarker Cohort: Phenotype of Tumor-Infiltrating Lymphocytes (TILs)	TILs in tumor biopsy samples will be identified using a multi-spectral Immunofluorescence (IF) assay.	Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Duration of Objective Response (DOR)		Up to 2 years
Disease Control Rate (DCR)		Up to 2 years
Progression Free Survival (PFS)		Up to 2 years
Overall Survival (OS)		Up to 2 years
Number of Participants Who Experience an Increase in Anti-Drug Antibodies (ADAs) to NT-I7		Up to 2 years
Biomarker Cohort: Objective Response Rate (ORR)		Up to 2 years
Incidence, Nature, and Severity of Adverse Events (AEs) graded according to National Cancer Institute Common Terminologies Criteria for Adverse Events (NCI CTCAE) v5.0		Up to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Participants with histologically or cytologically confirmed advanced or metastatic solid tumors.
Have measurable disease per RECIST v1.1.
Participants enrolling in the Phase 1b, Arms I, IV, IVa, V, and Va of the Phase 2a, and the Biomarker Cohort OC must have biopsiable disease.
Female participants who are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; female participants of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use dual methods of contraception for the duration of study treatment and for 120 days after the last dose of study treatment (pembrolizumab and/or NT-I7).
Non-sterile male participants who are sexually active with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use highly effective method(s) of contraception for the duration of study treatment and for 120 days after the last dose of study treatment (pembrolizumab and/or NT-I7).
Meet the requirements for the intended stages and arms (disease specific inclusion criteria), as follows:

Relapsed/refractory advanced solid tumors.

Has received at least 2 doses of an approved anti-PD-1/anti-PD-L1 monoclonal antibody (mAb).
Has demonstrated disease progression after anti-PD-1/anti-PD-L1.

Histopathologic or cytologic documented TNBC.
Received one or more prior therapies for TNBC in the advanced or metastatic setting, and prior treatment (for advanced, metastatic or (neo) adjuvant).

Had prior treatment with CPI. Participants with estimated glomerular filtration rate (EGFR), BRAF, or c-ros oncogene 1(ROS1) mutations or anaplastic lymphoma kinase (ALK) translocations are required to have received prior therapy with the appropriate tyrosine kinase inhibitor (TKI).

Recurrent extensive-stage SCLC; Received prior CPI therapy.

MSS-CRC (categorized as MSS by immunohistochemistry(IHC) or polymerase chain reaction (PCR).
Previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan; participants treated with CPI are not eligible.

Have documented radiographic progression to or documented in tolerance of first line systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine); participants treated previously with CPI are not eligible.

Up to 5 prior lines of treatment, including platinum-based treatment(s); participants treated previously with CPIs are not eligible.
Willing to provide pre- and on-treatment tumor biopsies.

Pregnant, lactating or breastfeeding.
Receiving chemotherapy or any anti-cancer therapy (approved or investigational) with half-life <1 week within 30 days or 5 half-lives.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if stable.
Participants who have received treatment with systemic immunosuppressive medications.
Has a history of non-infectious pneumonitis that required steroids or current pneumonitis.
Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137) and was discontinued from that treatment due to a Grade 3 or higher Immune related adverse event (irAE).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Merck Sharp & Dohme LLC

Investigators

Publications

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