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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
KEYNOTE A60 Trial 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.Check my eligibility
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.See study design
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.
KEYNOTE A60 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition meets the specific requirements for the trial's stages and parts.
Select...
I am either using birth control, postmenopausal, or have been surgically sterilized.
Select...
I have ovarian cancer, haven't had CPI treatment, and agree to give tumor samples.
Select...
My cancer has returned or didn't respond to treatment and is advanced.
Select...
I am a man and agree to follow specific birth control requirements.
Select...
My cancer is advanced or has spread to other parts of my body.
Select...
My cancer and previous treatments match the specific requirements for one of the study arms.
Select...
My cancer did not respond to previous anti-PD-1 or anti-PD-L1 treatments.
KEYNOTE A60 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biomarker Cohort: Distribution of Tumor-Infiltrating Lymphocytes (TILs)
Biomarker Cohort: Number of Tumor-Infiltrating Lymphocytes (TILs)
Biomarker Cohort: Phenotype of Tumor-Infiltrating Lymphocytes (TILs)
+2 moreSecondary outcome measures
Biomarker Cohort: Objective Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Objective Response (DOR)
+4 moreKEYNOTE A60 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.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,356 Total Patients Enrolled
NeoImmuneTechLead Sponsor
10 Previous Clinical Trials
292 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition meets the specific requirements for the trial's stages and parts.I have had lung inflammation treated with steroids or have it now.I have stable, previously treated brain metastases.I haven't taken any cancer treatment with a short effect in the last month.Participants in certain parts of the study need to have a disease that can be biopsied.I am either using birth control, postmenopausal, or have been surgically sterilized.I have ovarian cancer, haven't had CPI treatment, and agree to give tumor samples.My cancer has returned or didn't respond to treatment and is advanced.I stopped a treatment because of a severe immune system reaction.You have a medical condition that can be measured using specific guidelines.I am a man and agree to follow specific birth control requirements.My cancer is advanced or has spread to other parts of my body.My cancer and previous treatments match the specific requirements for one of the study arms.I have had a transplant of an organ, tissue, or bone marrow from another person.I have been treated with medications that suppress my immune system.My cancer did not respond to previous anti-PD-1 or anti-PD-L1 treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2a: CPI Naïve Pancreatic Cancer, Expansion Cohort
- Group 2: Biomarker Cohort: CPI Naïve Ovarian Cancer
- Group 3: Phase 1b: NT-I7 Dose Escalation
- Group 4: Phase 2a: CPI Treated Triple Negative Breast Cancer
- Group 5: Phase 2a: CPI Treated Non-small Cell Lung Cancer
- Group 6: Phase 2a: CPI Treated Small Cell Lung Cancer
- Group 7: Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer
- Group 8: Phase 2a: CPI Naïve Pancreatic Cancer
- Group 9: Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Expansion Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be allowed to participate in this clinical trial?
"To satisfy the requirements of this study, 238 eligible participants are required. The study's locations include MD Anderson Cancer Center and Barbara Ann Karmanos Cancer Institute."
Answered by AI
Is this study currently seeking new participants?
"According to the latest information available on clinicaltrials.gov, this study is still recruiting patients. The listing was first created on June 10th, 2020 and edited most recently on July 13th, 2022."
Answered by AI
For what indications is NT-I7 typically deployed?
"While malignant neoplasms is the primary condition that NT-I7 treats, this medication can also be effective for managing unresectable melanoma, microsatellite instability high, and chemotherapy resistance."
Answered by AI
Where are patients able to take part in this medical trial?
"At the moment, there are 7 active sites for this study. For example, MD Anderson Cancer Center in Houston, Barbara Ann Karmanos Cancer Institute in Detroit, and Fox Chase Cancer Center in Philadelphia. There are also 7 other locations."
Answered by AI
Are there any other ongoing or completed NT-I7 research studies?
"Out of the 1010 ongoing studies on NT-I7, 122 are in Phase 3. Many research facilities based in Houston, Texas are investigating NT-I7, but there are 36088 locations running trials for this medication globally."
Answered by AI
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