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Checkpoint Inhibitor
Personalized Immunotherapy for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Dan P 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
ECOG performance status of 0-1
Failure of prior immunotherapy as defined as: Progression of disease on anti-PD-1 mAb or anti-PD-L1 mAb treatment in the R/M setting.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment up to 36 months
Awards & highlights
Study Summary
This trial is testing a personalized immunotherapy approach for patients with head and neck squamous cell carcinoma that has returned or spread. Gene expression will be used to choose between two different agents, ipilimumab or relatlimab, to be given alongside nivolumab.
Who is the study for?
Adults with recurrent/metastatic squamous cell carcinoma of the head and neck, who have not responded to prior anti-PD-1/PD-L1 therapy. They must be in good health otherwise, with proper organ function and no history of certain other cancers or significant heart disease. Women must not be pregnant and agree to contraception.Check my eligibility
What is being tested?
The trial is testing personalized immunotherapy combinations: Nivolumab with either Relatlimab or Ipilimumab for patients whose cancer has progressed after previous immunotherapy. The choice between Relatlimab or Ipilimumab depends on individual gene expression levels related to immune response.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs, infusion reactions similar to allergic responses, fatigue, skin issues like rash or itching, hormonal imbalances due to thyroid involvement, and possibly increased susceptibility to infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer progressed despite previous immunotherapy.
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My blood counts and liver/kidney functions are within normal ranges.
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I am 18 years old or older.
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I have had 3 or fewer treatments for cancer that has returned or spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Probability of Objective Response (OR)
Secondary outcome measures
Adverse Events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Disease Control Rate (DCR)
Overall Survival (OS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Nivolumab+RelatlimabExperimental Treatment1 Intervention
Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks
One cycle is defined as 4 weeks of treatment and both drugs are given on the same day.
Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Group II: Nivolumab+IpilimumabExperimental Treatment1 Intervention
Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks.
Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
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Who is running the clinical trial?
Dan ZandbergLead Sponsor
5 Previous Clinical Trials
268 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,494 Total Patients Enrolled
Dan P Zandberg, MDPrincipal InvestigatorUPMC Hillman Cancer Center
3 Previous Clinical Trials
71 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have or have not had platinum-based chemotherapy.I have been treated for an autoimmune disease with drugs that affect my immune system in the last 3 months.My cancer progressed despite previous immunotherapy.My blood counts and liver/kidney functions are within normal ranges.I have had lung inflammation treated with steroids, or I currently have it.I am 18 years old or older.I haven't had cancer treatment in the last 2 weeks and have recovered from any previous treatments.I agree to use birth control during and for 7 months after my treatment.I do not have serious heart problems or recent heart attacks.I haven't had cancer, except for specific types, in the last 3 years.I have at least one tumor that can be measured.My cancer originates from the salivary gland or skin of the head and neck, or its origin is unknown.I have an immune system disorder or have been on strong immune system drugs recently.I have been diagnosed with HIV.I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.I have had a solid organ transplant.My heart's pumping ability is normal, confirmed by a test within the last 6 months.I have had 3 or fewer treatments for cancer that has returned or spread.I had severe side effects from previous immune therapy that are not expected to return with proper care.My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.I have taken a pregnancy test recently and it was negative.I am willing to use birth control or abstain from sex during and for 5 months after the study.I have not received Ipilimumab or Relatlimab for recurrent or metastatic cancer.I can provide a recent biopsy for LAG3 and CTLA4 gene analysis.
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.
What purpose does the Nivolumab+Relatlimab drug cocktail serve?
"Nivolumab+Relatlimab is most commonly used as an intervention for patients that have undergone anti-angiogenic therapy. However, it can also be effective in treating other conditions such as malignant neoplasms and unresectable melanoma."
Answered by AI
Could you elaborate on the side effects of this Nivolumab+Relatlimab treatment?
"Nivolumab+Relatlimab's safety is estimated to be a 2. This rating comes from the fact that it is currently in Phase 2 clinical trials. While there is data supporting its safety, none of the evidence collected thus far suggests that it is an effective medication."
Answered by AI
Are we able to enroll new participants in this research project at this time?
"This clinical trial is actively looking for patients. The information on the website clinicaltrials.gov shows that the trial was first posted on 6/5/2020 and most recently updated on 7/13/2022."
Answered by AI
Are there precedents for treatment with Nivolumab+Relatlimab?
"Nivolumab+Relatlimab is being trialed in 797 separate studies, 86 of which are still in Phase 3. The primary location for these trials is Pittsburgh, Pennsylvania; however, there are 43310 other sites running similar experiments."
Answered by AI
Could you inform me as to how many people are currently signed up for this research project?
"Correct, the clinical trial is still active and recruiting patients. According to the information on clinicaltrials.gov, the study was first posted on 6/5/2020, with the most recent update being on 7/13/2022. They are looking for a total of 40 patients at 1 location."
Answered by AI
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