NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT ID: NCT04332653
Last Updated: 2026-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
215 participants
INTERVENTIONAL
2020-06-10
2025-01-13
Brief Summary
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* 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).
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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 Day 1 of every 21 day cycle.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
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.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
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 on Day 1 of every 21 day cycle.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
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.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
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 every 21 day cycle.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
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 21 day cycle.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
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 every 21 day cycle.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
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 21 day cycle.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
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 day cycle.
NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
Interventions
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NT-I7
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)
Administered by intravenous (IV) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Applicable to the Dose escalation phase (Phase 1b) only: (Biopsy Arm)
* Relapsed/refractory advanced solid tumors.
Applicable to the Dose expansion phase (Phase 2a) only:
Anti-PD-1/anti-PD-L1 refractory criteria for CPI-treated TNBC, NSCLC, and SCLC
* 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.
Specific to Arm I: CPI-treated R/R TNBC (Biopsy Arm)
* 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).
Specific to Arm II: CPI-treated R/R NSCLC
* 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).
Specific to Arm III: CPI-treated R/R SCLC
* Recurrent extensive-stage SCLC; Received prior CPI therapy.
Specific to Arm IV and IVa: CPI-naïve R/R MSS-CRC (Biopsy Arm)
* 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.
Specific to Arm V and Va: CPI-naïve R/R Pancreatic Cancer (Biopsy Arm)
* 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.
Specific to Biomarker Cohort: CPI-naïve R/R Ovarian Cancer
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Merck Sharp and Dohme LLC, Rahway, NJ, USA
UNKNOWN
NeoImmuneTech
INDUSTRY
Responsible Party
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Locations
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Moffit Cancer Center
Tampa, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MK-3475-A60
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-A60
Identifier Type: OTHER
Identifier Source: secondary_id
NIT-110
Identifier Type: -
Identifier Source: org_study_id
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