We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (KEYNOTE A60)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332653
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
NeoImmuneTech

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).


Condition or disease Intervention/treatment Phase
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 Phase 1 Phase 2

Detailed Description:

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).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 1b/2a Study of NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Advanced Solid Tumors
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : May 20, 2024
Estimated Study Completion Date : May 20, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 21 day cycle.

 Drug: NT-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
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 every 21 day cycle.

 Drug: NT-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
Administered by intravenous (IV) injection
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 21 day cycle.

 Drug: NT-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
Administered by intravenous (IV) injection
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 day cycle.

 Drug: NT-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
Administered by intravenous (IV) injection
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 Day 1 of every 21 day cycle.

 Drug: NT-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
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
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
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 on Day 1 of every 21 day cycle.

 Drug: NT-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
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.

 Drug: NT-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
Administered by intravenous (IV) injection
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 every 21 day cycle.

 Drug: NT-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc

Drug: Pembrolizumab
Administered by intravenous (IV) injection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 2 years ]
    • 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)

  2. 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 [ Time Frame: Up to 2 years ]
    Statistical correlation of dose levels with safety and efficacy parameters.

  3. Phase 2a: Preliminary Assessment of the Objective Response Rate (ORR) of NT-I7 in Combination with Pembrolizumab [ Time Frame: Up to 2 years ]
  4. Biomarker Cohort: Number of Tumor-Infiltrating Lymphocytes (TILs) [ Time Frame: Up to 2 years ]
  5. Biomarker Cohort: Distribution of Tumor-Infiltrating Lymphocytes (TILs) [ Time Frame: Up to 2 years ]
    TILs in tumor biopsy samples will be identified using a multi-spectral Immunofluorescence (IF) assay.

  6. Biomarker Cohort: Phenotype of Tumor-Infiltrating Lymphocytes (TILs) [ Time Frame: Up to 2 years ]
    TILs in tumor biopsy samples will be identified using a multi-spectral Immunofluorescence (IF) assay.


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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(Participants must meet all the following to be eligible)

  • 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:

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:

  • 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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332653


Contacts
Layout table for location contacts
Contact: NIT Medical Director 301-250-4926 NIT110@neoimmunetech.com

Locations
Layout table for location information
United States, Florida
Moffit Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Dr. Kim Richard    813-745-1432    richard.kim@moffitt.org   
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Dr. Hirva Mamdani    313-576-8711    mamdanih@karmanos.org   
United States, Missouri
Washington University School of Medicine in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Dr. Daniel Morgensztern    314-362-5817    danielmorgensztern@wustl.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Dr. Christopher Hoimes    919-681-8602    christopher.hoimes@duke.edu   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Dr. Anthony Olszanskiy    215-214-1676    anthony.olszanski@fccc.edu   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37211
Contact: Dr. Johanna Bendell    615-329-6834    jbendell@tnonc.com   
United States, Texas
Mary Crowley Cancer Research Active, not recruiting
Dallas, Texas, United States, 75230
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Dr. Naing    713-563-1930    anaing@mdanderson.org   
Sponsors and Collaborators
NeoImmuneTech
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: NeoImmuneTech
ClinicalTrials.gov Identifier: NCT04332653    
Other Study ID Numbers: NIT-110 (KEYNOTE PNA60)
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NeoImmuneTech:
NT-I7 (Efineptakin alfa)
Solid Tumor
Pembrolizumab
Neoplasms
Lung
Breast
Pancreas
Colorectal
 Non-small Cell Lung
Small Cell Lung
Thoracic Neoplasms
Interleukin 7
Carcinoma
Cancer
Programmed cell death protein (PD-1)
Ovarian
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Breast Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents