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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

71%

White blood cell count decreased

65%

Neutrophil count decreased

59%

Anaemia

59%

Lymphocyte count decreased

53%

Platelet count decreased

41%

Cytokine release syndrome

29%

Neutropenia

29%

Decreased appetite

18%

Diarrhoea

18%

Vomiting

18%

Muscular weakness

18%

Dizziness

18%

Neurotoxicity

18%

Insomnia

18%

Pleural effusion

18%

Hypertension

12%

Pyrexia

12%

Hypoxia

12%

Febrile neutropenia

12%

Thrombocytopenia

12%

Tachycardia

12%

Conjunctival haemorrhage

12%

Fatigue

12%

Pain

12%

Contusion

12%

Hyperuricaemia

12%

Hypokalaemia

12%

Hypomagnesaemia

12%

Tremor

12%

Dyspnoea

12%

Pruritus

Appetite disorder

Extrasystoles

Hypercalcaemia

Atrial fibrillation

Blood creatinine increased

Enteritis

COVID-19

Pneumonia

Agraphia

Large intestine perforation

Hypofibrinogenaemia

Supraventricular extrasystoles

Ventricular tachycardia

Periorbital oedema

Visual impairment

Abdominal distension

Abdominal pain

Anal incontinence

Constipation

Dry mouth

Gastrointestinal disorder

Oedema

Oedema peripheral

Physical deconditioning

Jaundice

Ocular icterus

Conjunctivitis

Cytomegalovirus infection reactivation

Urinary tract infection

Fall

Alanine aminotransferase increased

Blood bilirubin increased

Dehydration

Hypocalcaemia

Hypophosphataemia

Arthralgia

Musculoskeletal chest pain

Amnesia

Peroneal nerve palsy

Anxiety

Confusional state

Urinary retention

Cough

Oropharyngeal pain

Night sweats

Seborrhoeic dermatitis

Deep vein thrombosis

Haematoma

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

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

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