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Checkpoint Inhibitor
Nivolumab + Relatlimab/Ipilimumab for Head and Neck Cancer
Phase 2
Recruiting
Led By Robert Ferris, MD, PhD
Research Sponsored by Robert Ferris
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Adverse Events related to treatment of nivolumab in combination with relatlimab
Objective Response Rate (ORR)
+1 moreSecondary outcome measures
Effector CD4+ cells
Effector CD8+ cells
Levels of peripheral blood lymphocytes (PBL)
+1 moreOther outcome measures
Gene expression signature
Single cell RNAseq pathways
Tumor mutational burden
Side effects data
From 2023 Phase 1 & 2 trial • 62 Patients • NCT0331061962%
Neutropenia
54%
Thrombocytopenia
46%
Fatigue
38%
Nausea
38%
Anaemia
38%
Dizziness
31%
Back pain
31%
Leukopenia
23%
Decreased appetite
23%
Lymphopenia
23%
Hypophosphataemia
23%
Diarrhoea
23%
Arthralgia
23%
Cytokine release syndrome
23%
Constipation
15%
Night sweats
15%
Weight decreased
15%
Neurotoxicity
15%
Tremor
15%
Dysarthria
15%
Dysphonia
15%
Muscular weakness
15%
Cough
15%
Hypotension
15%
Contusion
15%
Vomiting
15%
Sinusitis
15%
Candida infection
15%
Ecchymosis
8%
International normalised ratio increased
8%
Mastication disorder
8%
Benign prostatic hyperplasia
8%
Erythema
8%
Confusional state
8%
Brain fog
8%
Pruritus
8%
Viral infection
8%
Joint swelling
8%
Epistaxis
8%
Dermatitis acneiform
8%
Rash
8%
Liver function test increased
8%
Deep vein thrombosis
8%
Flushing
8%
Haematoma
8%
Paraesthesia
8%
Thrombophlebitis
8%
Haemorrhage intracranial
8%
Hyperkalaemia
8%
Hyporeflexia
8%
Acute kidney injury
8%
Abdominal distension
8%
Hypoalbuminaemia
8%
Vulvitis
8%
Bone pain
8%
Atrial fibrillation
8%
Orthostatic hypotension
8%
Coccydynia
8%
Neuropathy peripheral
8%
Dry eye
8%
Non-cardiac chest pain
8%
Oedema peripheral
8%
Blood creatinine increased
8%
Resting tremor
8%
Pollakiuria
8%
Agitation
8%
Delirium
8%
Depression
8%
Libido decreased
8%
Febrile neutropenia
8%
Pneumonia
8%
Abdominal pain
8%
Mucosal inflammation
8%
Swelling
8%
Hyponatraemia
8%
Headache
8%
Gastrooesophageal reflux disease
8%
Dry skin
8%
Ileus
8%
Dry mouth
8%
Hyperbilirubinaemia
8%
Pain in extremity
8%
Urinary tract pain
8%
Colitis ischaemic
8%
Intention tremor
8%
Anxiety
8%
Prostatic specific antigen increased
8%
Haematuria
8%
Hypokalaemia
8%
Myalgia
8%
Wheezing
8%
Hypervolaemia
8%
Oropharyngeal pain
8%
Influenza
8%
Aspartate aminotransferase increased
8%
Dehydration
8%
Infusion related reaction
8%
Limb discomfort
8%
Sinus tachycardia
8%
Pain
8%
Dyspnoea
8%
Tachypnoea
8%
Gastrointestinal haemorrhage
8%
Mesenteric artery stenosis
8%
Hypocalcaemia
8%
Hypomagnesaemia
8%
Rhinitis allergic
8%
Upper-airway cough syndrome
8%
Rash pruritic
8%
Alanine aminotransferase increased
8%
Rhinorrhoea
8%
Cerumen impaction
8%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and 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)
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
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Relatlimab
2018
Completed Phase 2
~1120
Find a Location
Who is running the clinical trial?
Robert FerrisLead Sponsor
6 Previous Clinical Trials
195 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,646 Previous Clinical Trials
4,131,062 Total Patients Enrolled
Robert L. Ferris, MD, PhDLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with LAG-3 targeted agents before.I do not have a second primary tumor at the time of my emergency use authorization.You have a mental illness or other problems that make it difficult for you to follow the study requirements.I have a specific type of throat cancer that has not been treated and meets certain size and spread criteria.I have had myocarditis before.I agree to use birth control during and after the study, and I won't donate sperm.I do not need to follow contraceptive guidelines due to my azoospermia, unless the study drug could harm a fetus through seminal fluid.I am not pregnant, will test to confirm, and will use birth control during and after the trial.I am 18 years old or older.I am a candidate for surgery to remove my cancer.I am fully active or can carry out light work.My heart's pumping ability is normal, confirmed by a test within the last 28 days.I was treated for head and neck cancer less than 5 years ago.You have had a serious allergic reaction to a type of medication called monoclonal antibodies in the past.I have or had an autoimmune disease like lupus, MS, IBD, or rheumatoid arthritis.My cancer has spread to distant parts of my body.I have a history of Hepatitis B or C.I am 18 years old or older.My tumor can be biopsied before treatment starts.My cancer has been tested for LAG-3 and PD-L1.My cancer is located in my mouth, throat, or voice box.I have previously received cancer treatments like radiation or chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab + Relatlimab
- Group 2: Nivolumab + Ipilimumab
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 vacancies available to participants in this research?
"Affirmative. The information available on clinicaltrials.gov highlights that this medical trial is presently recruiting participants. It was originally made public on October 22nd 2019, with the most recent update being issued on March 31st 2022. A total of 60 patients are expected to join from a single location."
Answered by AI
What primary conditions does Relatlimab treat?
"Relatlimab can be used to treat patients who have previously received anti-angiogenic therapy, as well as malignant neoplasm and unresectable melanoma. Additionally, this medication is effective in treating squamous cell carcinoma."
Answered by AI
Are there other investigations that have been conducted regarding Relatlimab?
"Currently, 86 trials involving Relatlimab are in Phase 3 of their studies and 766 overall. The majority of these clinical investigations are happening within Pittsburgh, Pennsylvania yet there are an additional 42765 sites where research is being conducted on this medication."
Answered by AI
What are the desired effects of participating in this clinical experiment?
"According to the research sponsor, Bristol-Myers Squibb, this study will measure Adverse Events related to nivolumab therapy over a period of four months. Additionally, secondary outcomes such as Levels of tumor infiltrating lymphocyte (TIL) subsets in peripheral blood and Radiographic response - measuring Change in tumor volume of target lesion via imaging measurements – will be evaluated alongside levels of Peripheral Blood Lymphocytes (PBL). These markers may illustrate the efficacy or toxicity associated with treatment."
Answered by AI
Has Relatlimab been granted regulatory clearance by the FDA?
"Although there is some evidence of Relatlimab's safety, the lack of efficacy findings warrants a score of 2 on our team's scale."
Answered by AI
Are there any limitations on the number of participants enrolled in this research project?
"Affirmative. The clinical trial, initially posted on October 22nd 2019, is now actively recruiting potential participants. As per the data hosted on clinicaltrials.gov , 60 people must be recruited from a single medical centre for this study to commence."
Answered by AI
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