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Cytokine

Immunotherapy Combination for Cancer

Phase 2

Recruiting

Led By Jason M Redman, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

ECOG performance status <2

Participants must have metastatic or unresectable locally advanced Gastric/GEJ cancer that has been histologically confirmed.

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled serious cardiac arrhythmia, clinically significant coagulopathy or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant women are excluded from this study because PD-L1 targeting via a CAR has unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with PD-L1 targeting via a CAR and N-803, breastfeeding should be discontinued if the mother is treated on this study for the duration of study participation and for at least 4 months after last dose of any study drug.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days after treatment (study calendar-last ae evaluation)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of using CAR-NK cells, in combination with pembrolizumab and N-803, to treat gastric or head and neck cancer.

Who is the study for?

Adults over 18 with advanced gastric or head and neck cancer, who've had standard treatment. They must have measurable disease, be in good physical condition (ECOG <2), and have proper organ function. Those with treated brain metastases without progression are eligible. Participants must not be pregnant, agree to contraception during the trial, and sign consent.

What is being tested?

The trial tests a combination of immunotherapies: irradiated PD-L1 CAR-NK cells plus pembrolizumab plus N-803 for their effectiveness against recurrent/metastatic gastric or head and neck cancers. Treatments involve IV infusions of NK cells, IV pembrolizumab every 6 weeks, and subcutaneous N-803 every 4 weeks for up to two years.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the treatments given through veins or under the skin, fatigue from energy depletion due to therapy response, possible blood disorders affecting cell counts or clotting factors.

Eligibility Criteria

Inclusion Criteria

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

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I can do most of my daily activities without help.

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My stomach cancer cannot be surgically removed and has been confirmed by lab tests.

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I have had or was not eligible for first-line chemotherapy for my stomach cancer, and if HER2 positive, received HER2 therapy.

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My blood tests show my organs are functioning well.

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My head or neck cancer cannot be removed by surgery and has spread.

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I am 18 years old or older.

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My blood clotting levels are stable on my current warfarin treatment.

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I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.

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I have had or was not eligible for first-line chemotherapy and have received PD-1 inhibitor therapy.

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My cancer is in the stomach or where the stomach meets the esophagus.

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 serious ongoing illnesses that would stop me from following the study's requirements.

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I am not pregnant or breastfeeding.

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I am not on any experimental drugs or cancer treatments, except for palliative radiotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until progression or death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until progression or death

This trial's timeline: 3 weeks for screening, Varies for treatment, and until progression or death for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To determine the clinical response rate (CR+PR) with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab in patients with head and neck squamous cell carcinoma and gastric/GEJ cancer.

Secondary study objectives

To assess duration of response in patients with HNSCC and/or gastric/GEJ cancer treated with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab

To assess the progression free survival (PFS) in patients with HNSCC and/or gastric/GEJ cancer treated with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab

To assess the safety and tolerability of irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab in patients with head and neck squamous cell carcinoma and/or gastric/GEJ cancer