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Cytokine

NT-I7 + Pembrolizumab for Solid Cancers (KEYNOTE A60 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by NeoImmuneTech

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet the disease specific inclusion criteria for intended stages and arms

Female participants must meet specific criteria for contraception or postmenopausal/surgically sterile status

Must not have

Has a history of non-infectious pneumonitis that required steroids or current pneumonitis

Receiving chemotherapy or any anti-cancer therapy with half-life <1 week within 30 days or 5 half-lives

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to see if it is safe and effective in treating advanced solid tumors.

Who is the study for?

This trial is for adults with advanced solid tumors like ovarian, pancreatic, lung (both small cell and non-small), breast, or colorectal cancer. They must have measurable disease and meet specific criteria based on the tumor type and previous treatments. Men and women must follow contraception rules unless postmenopausal or surgically sterile.

What is being tested?

The study tests NT-I7 combined with Pembrolizumab to find safe doses (Phase 1b) and assess anti-tumor effects in patients who've had prior checkpoint inhibitor treatment or are naïve to it (Phase 2a). It also looks at how immune cells in tumors might predict benefits from the treatment.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation of organs, infusion-related reactions, fatigue, skin issues, hormonal gland problems, flu-like symptoms including fever/chills/body aches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition meets the specific requirements for the trial's stages and parts.

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I am either using birth control, postmenopausal, or have been surgically sterilized.

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I am a man and agree to follow specific birth control requirements.

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My cancer is advanced or has spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had lung inflammation treated with steroids or have it now.

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I haven't taken any cancer treatment with a short effect in the last month.

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I stopped a treatment because of a severe immune system reaction.

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I have had a transplant of an organ, tissue, or bone marrow from another person.

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I have been treated with medications that suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biomarker Cohort: Distribution of Tumor-Infiltrating Lymphocytes (TILs)

Biomarker Cohort: Phenotype of Tumor-Infiltrating Lymphocytes (TILs)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Phase 2a: CPI Treated Triple Negative Breast CancerExperimental Treatment2 Interventions

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.

Group II: Phase 2a: CPI Treated Small Cell Lung CancerExperimental Treatment2 Interventions

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.

Group III: Phase 2a: CPI Treated Non-small Cell Lung CancerExperimental Treatment2 Interventions

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.

Group IV: Phase 2a: CPI Naïve Pancreatic Cancer, Expansion CohortExperimental Treatment2 Interventions

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.

Group V: Phase 2a: CPI Naïve Pancreatic CancerExperimental Treatment2 Interventions

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.

Group VI: Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Expansion CohortExperimental Treatment2 Interventions

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.

Group VII: Phase 2a: CPI Naïve Microsatellite Stable Colorectal CancerExperimental Treatment2 Interventions

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.

Group VIII: Phase 1b: NT-I7 Dose EscalationExperimental Treatment2 Interventions

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.

Group IX: Biomarker Cohort: CPI Naïve Ovarian CancerExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab (KEYTRUDA®)

2019

Completed Phase 2

~190

0 / 9Eligibility criteria met