Checkpoint Inhibitor

Relatlimab for Head and Neck Squamous Cell Carcinoma

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

Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx will be included.

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 4 months

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Eligibility Criteria

Inclusion Criteria

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

Select...

You have a cancerous tumor in your 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

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events related to treatment of nivolumab

Therapeutic procedure

Adverse Events related to treatment of nivolumab in combination with relatlimab

Secondary outcome measures

Effector CD4+ cells

Effector CD8+ cells

Levels of peripheral blood lymphocytes (PBL)

+2 more

Other outcome measures

Gene expression signature

Single cell RNAseq pathways

Tumor mutational burden

Side effects data

From 2022 Phase 1 & 2 trial • 578 Patients • NCT02488759

41%

Diarrhoea

36%

Nausea

35%

Fatigue

32%

Anaemia

28%

Constipation

26%

Pruritus

25%

Vomiting

25%

Pyrexia

24%

Decreased appetite

23%

Hypothyroidism

23%

Abdominal pain

23%

Urinary tract infection

20%

Arthralgia

19%

Rash maculo-papular

17%

Asthenia

17%

Alanine aminotransferase increased

17%

Headache

16%

Hyperthyroidism

15%

Aspartate aminotransferase increased

15%

Malignant neoplasm progression

15%

Oedema peripheral

14%

Back pain

13%

Lipase increased

13%

Hypomagnesaemia

13%

Cough

12%

Rash

12%

Hypoalbuminaemia

11%

Dizziness

11%

Hyponatraemia

11%

Hypokalaemia

10%

Blood creatinine increased

10%

Dyspnoea

Amylase increased

Dry skin

Pneumonitis

Colitis

Myalgia

Hyperglycaemia

Pain in extremity

Chills

Acute kidney injury

Weight decreased

Insomnia

Upper respiratory tract infection

Blood alkaline phosphatase increased

Hepatotoxicity

Dyspepsia

Flank pain

Pelvic pain

Dry mouth

Vaginal haemorrhage

Productive cough

Intestinal obstruction

Mucosal inflammation

Hypertension

Lymphoedema

Peripheral sensory neuropathy

Anxiety

Stomatitis

White blood cell count decreased

Sepsis

Infusion related reaction

Hypercalcaemia

Abdominal pain upper

Pyelonephritis

Muscular weakness

Nasal congestion

Hypotension

Pain

Hydronephrosis

Respiratory tract infection

Rhinitis

Immune-mediated enterocolitis

Skin infection

Procedural pain

Influenza like illness

Musculoskeletal chest pain

Tumour pain

Female genital tract fistula

Dysgeusia

Transaminases increased

Confusional state

Oropharyngeal pain

Pulmonary embolism

Dysphagia

Non-cardiac chest pain

Hypophosphataemia

Groin pain

Autoimmune hepatitis

Cardiac arrest

Ileus

Gastritis

Dehydration

Infected neoplasm

Nasopharyngitis

Conjunctivitis

Fall

Lymphocyte count decreased

Musculoskeletal pain

Paraesthesia

Hypophysitis

Pericardial effusion

Haematuria

Deep vein thrombosis

Vertigo

Pyelonephritis acute

Tumour haemorrhage

Pneumothorax

Tongue ulceration

Face oedema

Skin ulcer

Upper-airway cough syndrome

Night sweats

Neck pain

Oesophagitis

Hepatitis

Soft tissue infection

Tuberculosis

Diabetic ketoacidosis

Dyspnoea exertional

Pancreatitis

Encephalitis

Uveitis

Rash pruritic

Death

Sudden death

Hypertransaminasaemia

Kidney infection

Septic shock

Recall phenomenon

Blood magnesium decreased

Liver function test increased

Fistula

Bell's palsy

Device occlusion

Autoimmune nephritis

Ureteric stenosis

Urinary retention

Urinary tract obstruction

Immune-mediated lung disease

Pleural effusion

Chest pain

Anorectal disorder

Thyroid disorder

Abdominal distension

Anal fistula

Inappropriate antidiuretic hormone secretion

Autoimmune cholangitis

Hepatic function abnormal

Hypersensitivity

Pneumonia

Lung adenocarcinoma

Ear pain

Bronchitis

Lymph node pain

Performance status decreased

Systemic inflammatory response syndrome

Urosepsis

Fracture

Encephalopathy

Small intestinal obstruction

Myocarditis

Ascites

Gait disturbance

100%

80%

60%

40%

20%

Study treatment Arm

Metastatic Combo B

Metastatic Combo D

Metastatic Monotherapy

Neoadjuvant

Metastatic Combo C

Metastatic Combo A

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

Group I: Nivolumab + RelatlimabExperimental Treatment2 Interventions

Nivolumab 480mg IV + Relatlimab 160mg IV D1 - optional Nivolumab 480 mg IV + Relatlimab 160mg 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)

Group III: NivolumabExperimental Treatment1 Intervention

Nivolumab 480 mg IV D1 and then optional Nivo 480 mg IV D28 (D28 clinician discretion i.e. surgery postponed)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

FDA approved

Nivolumab

FDA approved

Relatlimab

Not yet FDA approved

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,576 Previous Clinical Trials

4,033,765 Total Patients Enrolled

Robert FerrisLead Sponsor

6 Previous Clinical Trials

195 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

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04080804 — Phase 2

Head and Neck Squamous Cell Carcinoma Research Study Groups: Nivolumab, Nivolumab + Relatlimab, Nivolumab + Ipilimumab

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04080804 — Phase 2

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04080804 — Phase 2

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

Recent research and studies

clinicaltrials.govStudy

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Robert Ferris 2020. "Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04080804.

All > Head And Neck Cancer