Squamous Cell Carcinoma of the Head and NeckPhase 2NCT04326257
Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy
A Phase 2 study testing Nivolumab+Relatlimab and Nivolumab+Ipilimumab in people with Squamous Cell Carcinoma of the Head and Neck, run by Dan Zandberg at 1 site in United States.
Trial summary
In this Phase II trial of personalized immunotherapy in R/M HNSCC, gene expression of LAG3 and CTLA4 by RNA seq will be determined to select the appropriate agent (Ipilimumab or Relatlimab) to add to Nivolumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Nivolumab+Relatlimab and Nivolumab+Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2020to 12 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent and/or Metastatic squamous cell carcinoma of the head and neck that is not amenable to therapy with curative intent. Patients who refuse salvage surgery or radiation for recurrence are potentially eligible.
- 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.
- Both patients that have received platinum based chemotherapy prior or have not yet received platinum based chemotherapy are eligible.
- Patients cannot have received more than 3 total lines of prior systemic therapy in the recurrent/metastatic setting.
- ECOG performance status of 0-1
Show all 23Show fewer
- Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.
- Provide adequate tissue (core or incisional/excisional biopsy) prior to starting study for analysis for gene expression of LAG3 and CTLA4 per OmniSeq Immune Report Card. FNA is not adequate. Archival tissue can only be used if it was obtained in the recurrent/metastatic setting and there has been no subsequent cancer treatment after that tissue was obtained.
- Life expectancy of at least 12 weeks based on investigator estimate.
- Age ≥ 18 years old
- LVEF assessment with documented LVEF ≥50% by either TTE or MUGA (TTE preferred test) within 6 months from first study drug administration
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤2.5 x institutional ULN
- creatinine ≤ institutional ULN
- OR
- glomerular filtration rate ≥40 mL/min/1.73 m2 for patients with creatinine levels. (GFR) above institutional normal.
- Female subjects of childbearing potential should have a negative urine or serum pregnancy within 1 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential should be willing to use 1 methods of birth control or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- SCC of salivary gland origin or cutaneous SCC of the head and neck. HNSCC of unknown origin ARE eligible.
- Patients who received Ipilimumab or Relatlimab in the recurrent/metastatic setting will be excluded.
- Is currently participating in or has participated in a study of an investigational agent or used an investigational device within 2 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (equivalent of >10 mg of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has had a prior monoclonal antibody, chemotherapy, or targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier (alopecia is an exception). Note: Subjects with ≤ Grade 2 neuropathy, ototoxicity, hypothyroidism or hyperthyroidism, are an exception to this criterion and qualify for the study.
- History of other malignancy within 3 years with the exception of prior HNSCC, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix.
Show all 26Show fewer
- Has an active autoimmune disease requiring systemic immunosuppressive treatment within the past 3 months. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
- Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
- Myocardial infarction (MI) or stroke/transient ischemic attack (TIA) within the 6 months prior to consent;
- Uncontrolled angina within the 3 months prior to consent;
- Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, or poorly controlled atrial fibrillation);
- QTc prolongation > 480 msec;
- History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, congestive heart failure with New York Heart Association [NYHA] functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled deep venous thrombosis, etc.);
- Cardiovascular disease-related requirement for daily supplemental oxygen
- History of two or more MIs OR two or more coronary revascularization procedures
- Subjects with history of myocarditis, regardless of etiology.
- A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- Subjects with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).
- Troponin T (TnT) or I (TnI) > 2 × institutional ULN. Subjects with TnT or TnI levels between > 1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤1 x ULN. If TnT or TnI levels are >1 to 2 × ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment based on the discretion of the PI. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2 x ULN, the subject may undergo a cardiac evaluation and be considered for treatment, based on the discretion of the PI.
- Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 24 weeks after the last dose of trial treatment.
- Has a history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has active Hepatitis B or Hepatitis C
- Has a history of a solid organ transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase II Trial of Personalized Immunotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck That Have Progressed on Prior Immunotherapy
In this Phase II trial of personalized immunotherapy in R/M HNSCC, gene expression of LAG3 and CTLA4 by RNA seq will be determined to select the appropriate agent (Ipilimumab or Relatlimab) to add to Nivolumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) who have failed prior immunotherapy with anti-PD-1 or PD-L1 mAb therapy. The agent, either Ipilimumab or Relatlimab will be chosen based on the highest relevant immune gene expression (CTLA4 or LAG-3) as long as the minimum difference required is met.
Read the detailed description
In this Phase II non-randomized trial, n=40 eligible patients will have tumor tissue (core or excisional/incisional) for gene expression of LAG3 and CTLA4 via RNA seq per OmniSeq Immune Report Card to determine which drug (either Relatlimab or Ipilimumab) will be added to Nivolumab for treatment. The patient will then receive the prescribed therapy continuously for up to 24 cycles (1 cycle = 28 days). The drug to be added to Nivolumab will be based on which relevant gene has the highest expression as long as the minimum difference required is met. If the minimum difference is not met than a patient will be randomized to either Nivolumab plus Relatlimab or Nivolumab plus Ipilimumab.
The patient will then receive the prescribed therapy continuously for up to 24 cycles (1 cycle = 28 days) with repeat imaging prior to every 3rd cycle until progression of disease. Response, evaluated by RECIST 1.1, with modifications to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial. If the patient has confirmed progression the patient may be eligible to undergo a second biopsy and second treatment on trial. If these criteria are met the patient will then be treated with this new combination with repeat imaging prior to every 3rd cycle as per initial treatment, until progression of disease.
- Being tested
- Nivolumab+Relatlimab, Nivolumab+Ipilimumab
- Keywords
- nivolumab, Relatlimab, Ipilimumab, immunotherapy, anti-PD-1, anti-PD-L1, RECIST 1.1, recurrent cancer, metastatic cancer, tumor microenvironment analysis, LAG-3, CTLA-4
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab+RelatlimabDrug
Also called Nivolumab: OPDIVO/ BMS-936558/ MDX1106/ ONO-4538;, Relatlimab: BMS-986016
IV administration of both Nivolumab and Relatlimab
Nivolumab+IpilimumabDrug
Also called Nivolumab: OPDIVO/ BMS-936558/ MDX1106/ ONO-4538, Ipilimumab: YERVOY/ BMS-734016/ MDX-010
IV administration of both Nivolumab and Ipilimumab
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab+Relatlimab | Experimental | 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. Receives: Drug: Nivolumab+Relatlimab |
| Nivolumab+Ipilimumab | Experimental | 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. Receives: Drug: Nivolumab+Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Objective Response (OR) - Selected Treatment
The probability of response to therapy in patients who have progressed on prior immunotherapy. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From start of treatment, up to 36 months
Secondary outcomes (6)
Probability of Objective Response (OR) - Randomized Treatment
The probability of response to therapy in patients who have progressed on prior immunotherapy. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From start of treatment, up to 36 months
Disease Control Rate (DCR)
The percent probability of not experiencing disease progression in patients regardless of selected/randomized treatment. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.
Measured: From start of treatment, up to 36 months
Progression-free Survival (PFS)
The length of time from the start of treatment that patients live with disease that does not progress per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in patients who have progressed on prior immunotherapy. Per RECIST, Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions.It also includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: From start of treatment up to 36 months
Overall Survival (OS)
The length of time from the start of treatment that patients remain alive, in patients who have progressed on prior immunotherapy.
Measured: From start of treatment, up to 36 months
Duration of Disease Control
Mean number of months that patients who had Stable Disease experienced disease control. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Stable Disease (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.
Measured: From start of treatment, up to 36 months
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Adverse Events possibly, probably or definitely related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 experienced.
Measured: From start of treatment, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start14 May 2020
- Primary completion12 Aug 2023
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this open-label, 2 parallel arms trial, RNA seq analysis via the Omniseq immune report card will be used to determine which drug (Relatlimab or Ipilimumab) will be added to Nivolumab for treatment.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Zandberg
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Dan Zandberg, University of Pittsburgh
- Investigators
- Dan P Zandberg, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326257
- Sponsor's protocol ID
- HCC 18-156
- Status last verified
- Dec 2025
- First submitted
- 25 Mar 2020
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Personalized Immunotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck That Have Progressed on Prior Immunotherapy
- ClinicalTrials.gov ID
- NCT04326257
- Acronym / sponsor ID
- HCC 18-156
- Keywords
- nivolumab, Relatlimab, Ipilimumab, immunotherapy, anti-PD-1, anti-PD-L1, RECIST 1.1, recurrent cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dan ZandbergUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 14 May 2020 (actual)
- Primary completion
- 12 Aug 2023 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Posted 8 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this Phase II trial of personalized immunotherapy in R/M HNSCC, gene expression of LAG3 and CTLA4 by RNA seq will be determined to select the appropriate agent (Ipilimumab or Relatlimab) to add to Nivolumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) who have failed prior immunotherapy with anti-PD-1 or PD-L1 mAb therapy. The agent, either Ipilimumab or Relatlimab will be chosen based on the highest relevant immune gene expression (CTLA4 or LAG-3) as long as the minimum difference required is met.
Detailed description
In this Phase II non-randomized trial, n=40 eligible patients will have tumor tissue (core or excisional/incisional) for gene expression of LAG3 and CTLA4 via RNA seq per OmniSeq Immune Report Card to determine which drug (either Relatlimab or Ipilimumab) will be added to Nivolumab for treatment. The patient will then receive the prescribed therapy continuously for up to 24 cycles (1 cycle = 28 days). The drug to be added to Nivolumab will be based on which relevant gene has the highest expression as long as the minimum difference required is met. If the minimum difference is not met than a patient will be randomized to either Nivolumab plus Relatlimab or Nivolumab plus Ipilimumab.
The patient will then receive the prescribed therapy continuously for up to 24 cycles (1 cycle = 28 days) with repeat imaging prior to every 3rd cycle until progression of disease. Response, evaluated by RECIST 1.1, with modifications to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial. If the patient has confirmed progression the patient may be eligible to undergo a second biopsy and second treatment on trial. If these criteria are met the patient will then be treated with this new combination with repeat imaging prior to every 3rd cycle as per initial treatment, until progression of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this open-label, 2 parallel arms trial, RNA seq analysis via the Omniseq immune report card will be used to determine which drug (Relatlimab or Ipilimumab) will be added to Nivolumab for treatment.
| Arm | Type | Receives |
|---|---|---|
| Nivolumab+Relatlimab | Experimental | Drug: Nivolumab+RelatlimabNivolumab 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. |
| Nivolumab+Ipilimumab | Experimental | Drug: Nivolumab+IpilimumabNivolumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Recurrent and/or Metastatic squamous cell carcinoma of the head and neck that is not amenable to therapy with curative intent. Patients who refuse salvage surgery or radiation for recurrence are potentially eligible.
- Failure of prior immunotherapy as defined as:
- Patients cannot have received more than 3 total lines of prior systemic therapy in the recurrent/metastatic setting.
- ECOG performance status of 0-1
- Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.
Key exclusion criteria (26 listed)
- SCC of salivary gland origin or cutaneous SCC of the head and neck. HNSCC of unknown origin ARE eligible.
- Patients who received Ipilimumab or Relatlimab in the recurrent/metastatic setting will be excluded.
- Is currently participating in or has participated in a study of an investigational agent or used an investigational device within 2 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (equivalent of >10 mg of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has had a prior monoclonal antibody, chemotherapy, or targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier (alopecia is an exception). Note: Subjects with ≤ Grade 2 neuropathy, ototoxicity, hypothyroidism or hyperthyroidism, are an exception to this criterion and qualify for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab+RelatlimabAlso: Nivolumab: OPDIVO/ BMS-936558/ MDX1106/ ONO-4538;, Relatlimab: BMS-986016IV administration of both Nivolumab and Relatlimab | Drug | Nivolumab+Relatlimab |
| Nivolumab+IpilimumabAlso: Nivolumab: OPDIVO/ BMS-936558/ MDX1106/ ONO-4538, Ipilimumab: YERVOY/ BMS-734016/ MDX-010IV administration of both Nivolumab and Ipilimumab | Drug | Nivolumab+Ipilimumab |
Primary outcome
Probability of Objective Response (OR) - Selected Treatment
Time frame: From start of treatment, up to 36 months
The probability of response to therapy in patients who have progressed on prior immunotherapy. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
6 secondary outcomes
Probability of Objective Response (OR) - Randomized Treatment
Time frame: From start of treatment, up to 36 months
Disease Control Rate (DCR)
Time frame: From start of treatment, up to 36 months
Progression-free Survival (PFS)
Time frame: From start of treatment up to 36 months
Overall Survival (OS)
Time frame: From start of treatment, up to 36 months
Duration of Disease Control
Time frame: From start of treatment, up to 36 months
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From start of treatment, up to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan P Zandberg, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab+Relatlimab and Nivolumab+Ipilimumab in people with Squamous Cell Carcinoma of the Head and Neck, run by Dan Zandberg at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of Objective Response (OR) - Selected Treatment (time frame: From start of treatment, up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.