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Nivolumab + Relatlimab/Ipilimumab for Head and Neck Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619Trial Design
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- 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.
- Group 1: Nivolumab + Relatlimab
- Group 2: Nivolumab + Ipilimumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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