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Immunotherapy
NK Cells + Nivolumab + Relatlimab for Melanoma
Phase 1
Waitlist Available
Led By Alice Y Zhou, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of histologically confirmed advanced or metastatic melanoma that has progressed after at least 12 weeks or a minimum of 2 doses of treatment with a standard of care PD1/PDL1 containing therapy (nivolumab, pembrolizumab, atezolizumab, or durvalumab) as their last treatment regimen.
Able and willing to undergo leukapheresis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 3 years)
Awards & highlights
Study Summary
This trial tests safety and effectiveness of new medicine to treat advanced melanoma. It will test two types of memory-like natural killer cells from either patient's own body or from another person.
Who is the study for?
Adults with advanced or metastatic melanoma that worsened after treatment with certain immunotherapies. Participants must be in good health, able to undergo cell harvesting, not have severe active infections like HIV or hepatitis, and cannot be pregnant. They should have stable organ function and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing memory-like natural killer cells combined with nivolumab and relatlimab for treating melanoma. There are two groups: one receiving NK cells from their own body (autologous) and another from a donor (allogenic). The goal is to see if these treatments are safe and can shrink tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions which may cause discomfort or allergic responses during treatment administration, fatigue, potential infection risks due to immune modulation, and other non-specified drug-related adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced melanoma worsened after treatment with a PD1/PDL1 therapy.
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I am willing and able to undergo a procedure to collect white blood cells.
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I can take care of myself but may not be able to do heavy physical work.
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I am 18 years old or older.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Objective response rate (ORR)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Allogeneic: Memory-like natural killer cells + nivolumab + relatilimabExperimental Treatment3 Interventions
Subjects with a haploidentical donor will enroll into arm 2, where ML NK cells sourced from the haploidentical allogenic donor will be activated.
Subjects will receive the IV infusion of ML NK cells on Day 0.
Relatlimab/nivolumab will be initiated at day 29 and continue every 28 days for 11 cycles, or until unacceptable toxicity, or progression, whichever is earlier.
Group II: Arm 1: Autologous: Memory-like natural killer cells + nivolumab + relatilimabExperimental Treatment3 Interventions
Subjects enrolled into arm 1 will receive autologous ML NK cells on Day 0.
Relatlimab/nivolumab will be initiated at day 29 and continue every 28 days for 11 cycles, or until unacceptable toxicity, or progression, whichever is earlier.
Group III: Allogeneic DonorsActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,676 Total Patients Enrolled
11 Trials studying Melanoma
300 Patients Enrolled for Melanoma
Alice Y Zhou, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your oxygen level is at least 90% when breathing normally.Your total bilirubin level is less than 2 mg/dL.You are expected to live for more than 12 weeks.My HLA status does not affect my eligibility.My organs are functioning well.I do not have any untreated infections like HIV or Hepatitis B/C.I am willing and able to undergo a procedure to collect white blood cells.I can stop taking corticosteroids and immune suppressants for 14 days before and 30 days after my treatment, except for low doses if needed.I am not pregnant and agree to use two forms of birth control during and 30 days after the study.I have new lung changes on a CT scan not checked with a scope, but stable after treatment if due to infection.My advanced melanoma worsened after treatment with a PD1/PDL1 therapy.I have side effects from previous cancer immunotherapy that are not severe.You do not have hepatitis, HTLV, or HIV.I don't need immediate treatment for brain metastasis and haven't taken anti-seizure medication or steroids in the last 7 days.I had brain metastases, treated and stable for 4 weeks, and off certain meds for 7 days.I stopped cancer immunotherapy due to a severe immune-related side effect.I have never received TIL therapy for my cancer.I can take care of myself but may not be able to do heavy physical work.I am 18 years old or older.I am in good health and can undergo a procedure to collect immune cells.Your liver enzymes (AST and ALT) are less than 3 times the upper limit of normal.My kidney function, measured by creatinine levels or clearance, is within the normal range.I am 18 years old or older.I do not have uncontrolled heart problems.I have a donor for NK cell therapy who meets all required criteria.I have an autoimmune disorder but only take low-dose steroids.Your heart's ejection fraction is at least 45%.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Allogeneic: Memory-like natural killer cells + nivolumab + relatilimab
- Group 2: Allogeneic Donors
- Group 3: Arm 1: Autologous: Memory-like natural killer cells + nivolumab + relatilimab
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.
Are there any remaining openings for participating in this research?
"According to clinicaltrials.gov, this study is not currently seeking participants at the present time. While it was posted on February 28th 2023 and edited lastly on November 16th 2022, there are still 767 other trials accepting candidates presently."
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