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Checkpoint Inhibitor

Nivolumab + Relatlimab/Ipilimumab for Head and Neck Cancer

Phase 2

Recruiting

Led By Dan Zandberg, MD

Research Sponsored by Dan Zandberg

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Eligible for surgical resection.

Must not have

Prior treatment with LAG-3 targeted agents.

If second primary tumor is found at the time of EUA, the subject will be excluded from study participation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding an anti-PD1 antibody to either an anti-CTLA4 antibody or an anti-LAG3 antibody will help improve the body's response to the tumor in people with resectable locally advanced HNSCC.

Who is the study for?

Adults with certain types of head and neck cancers that can be surgically removed are eligible. They must have tumors accessible for biopsy, no distant metastasis, a good performance status, and agree to use contraception. Excluded are those with hepatitis B or C, recent heart issues, previous cancer treatments within 5 years, severe reactions to monoclonal antibodies or active autoimmune diseases.

What is being tested?

The trial is testing the safety and effectiveness of Nivolumab alone or combined with Relatlimab or Ipilimumab in treating head and neck cancer before surgery. The goal is to boost the body's immune response against tumor cells by using these drugs.

What are the potential side effects?

Potential side effects include immune-related inflammation in various organs (like colitis), fatigue, skin rash, hormone gland problems (like thyroid dysfunction), infusion reactions during drug administration, and possibly others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am a candidate for surgery to remove my cancer.

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I am fully active or can carry out light work.

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My heart's pumping ability is normal, confirmed by a test within the last 28 days.

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My cancer is located in my mouth, throat, or voice box.

Exclusion Criteria

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

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I have been treated with LAG-3 targeted agents before.

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I do not have a second primary tumor at the time of my emergency use authorization.

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I have had myocarditis before.

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I was treated for head and neck cancer less than 5 years ago.

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I have or had an autoimmune disease like lupus, MS, IBD, or rheumatoid arthritis.

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My cancer has spread to distant parts of my body.

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I have a history of Hepatitis B or C.

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I have previously received cancer treatments like radiation or chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Therapeutic procedure

Adverse Events related to treatment of nivolumab in combination with relatlimab

Objective Response Rate (ORR)

+1 more

Secondary study objectives

Effector CD4+ cells

Effector CD8+ cells

Levels of peripheral blood lymphocytes (PBL)

+1 more

Other study objectives

Gene expression signature

Single cell RNAseq pathways

Tumor mutational burden

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619

43%

Neutrophil count decreased

29%

Anaemia

29%

White blood cell count decreased

14%

Blood uric acid increased

14%

Back pain

14%

Erythema

14%

COVID-19

14%

Headache

14%

Neurotoxicity

14%

Neutropenia

14%

Palpitations

14%

Dry eye

14%

Diarrhoea

14%

Dyspepsia

14%

Chills

14%

Oedema peripheral

14%

Cytokine release syndrome

14%

Pneumonia

14%

Aspartate aminotransferase increased

14%

International normalised ratio increased

14%

Lymphocyte count decreased

14%

Platelet count decreased

14%

Dehydration

14%

Hypokalaemia

14%

Hypomagnesaemia

14%

Bone pain

14%

Myalgia

14%

Pain in jaw

14%

Dizziness

14%

Nystagmus

14%

Confusional state

14%

Cough

14%

Dyspnoea

14%

Tachypnoea

14%

Alopecia

14%

Rash maculo-papular

14%

Embolism

100%

80%

60%

40%

20%

Study treatment Arm

Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)

Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)

Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)

Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)

Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nivolumab + RelatlimabExperimental Treatment2 Interventions

Nivolumab 480mg IV + Relatlimab 480mg IV D1 - optional Nivolumab 480 mg IV + Relatlimab 480mg IV D28 (D28 at clinician discretion i.e. surgery postponed)

Group II: Nivolumab + IpilimumabExperimental Treatment2 Interventions

Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg D1 then Nivolumab 3 mg /kg D14 and then optional Nivolumab 3 mg/kg D28 (D28 at clinician discretion i.e., surgery postponed)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3420

Nivolumab

2015

Completed Phase 3

~4010

Relatlimab

2019

Completed Phase 2

~1150

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dan ZandbergLead Sponsor

6 Previous Clinical Trials

256 Total Patients Enrolled

Robert FerrisLead Sponsor

6 Previous Clinical Trials

163 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,696 Previous Clinical Trials

4,098,991 Total Patients Enrolled

Robert L. Ferris, MD, PhDLead Sponsor

1 Previous Clinical Trials

42 Total Patients Enrolled

Dan Zandberg, MDPrincipal InvestigatorUPMC Hillman Cancer Center

3 Previous Clinical Trials

133 Total Patients Enrolled

Robert Ferris, MD, PhDPrincipal Investigator - UPMC Hillman Cancer Center

Eye & Ear Hospital of Pittsburgh, Magee-Women's Hospital of UPMC, Select Specialty Hospital of Pittsburgh-UPMC, UPMC Montefiore, UPMC Horizon-Greenville, UPMC Mercy, UPMC Presbyterian, UPMC Shadyside

Johns Hopkins University School Of Medicine (Medical School)

Johns Hopkins University School Medicine (Residency)

3 Previous Clinical Trials

277 Total Patients Enrolled