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Immunotherapy

NK Cells + Nivolumab + Relatlimab for Melanoma

Phase 1

Recruiting

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

Must not have

Uncontrolled or untreated infections, including but not limited to HIV, Hepatitis B or C infection.

Prior history of an immune-related Grade 3 or 4 AE attributed to prior cancer immunotherapy (other than endocrinopathy managed with either replacement therapy or asymptomatic elevation of serum amylase or lipase) that resulted in permanent discontinuation of the prior immunotherapeutic agent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 3 years)

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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I do not have any untreated infections like HIV or Hepatitis B/C.

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I stopped cancer immunotherapy due to a severe immune-related side effect.

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I have never received TIL therapy for my cancer.

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I do not have uncontrolled heart problems.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 3 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

For treatment with cells from an allogeneic source: Incidence and severity of adverse events

For treatment with cells from an autologous source: Incidence and severity of adverse events

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Objective response rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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 * Subjects will receive the IV infusion of ML NK cells on Day 0. * Relatlimab and 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 and 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

2015

Completed Phase 3

~4010

0 / 10Eligibility criteria met