Head and Neck CancerPhase 2NCT07179315
A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment
A Phase 2 study testing cemiplimab+fianlimab and Cemiplimab in people with Head and Neck Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer who have detectable minimal-residual disease after definitive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cemiplimab+fianlimab and Cemiplimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2026to 30 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients must have history of histologically confirmed squamous cell carcinoma of the oropharynx.
- Must be HPV positive; testing must be compliant with meeting any one or more of the following criteria:
- p16 IHC positivity (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al.37).
- HPV PCR positivity.
- HPV in situ hybridization (ISH) positivity.
- Completed curative intent therapy. Acceptable curative intent therapies may include any combination of surgery, radiotherapy, and/or chemotherapy is eligible. Curative intent therapy must be completed at least 1 month prior to enrollment.
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- Any T or N stage at time of initial diagnosis is permitted, including patients with unknown primary, supraclavicular or mediastinal nodal involvement at the time of curative intent treatment.
- Detectable ctHPVDNA in plasma confirmed by NavDx prior to enrollment based on the clinically validated circulating tumor-tissue-modified HPV (TTMV®) DNA plasma assay. Patients with detectable ctHPVDNA in plasma from other commercially available CLIA-certified assays are also eligible, however a positive NavDx assay is required and will be obtained during screening.
- PD-L1 biomarker analysis from a core or excisional biopsy must be performed by IHC using the 22C3 antibody and a CPS score must be calculated for stratification. If unavailable, result from a fine-needle aspirate can also be acceptable. Local testing is acceptable.
- No definitive clinical or radiographic evidence of disease evaluated by clinical examination and cross-sectional imaging and/or PET imaging prior to randomization. Patients with equivocal results on imaging are eligible.
- Patients must be willing and able to provide written informed consent for the trial.
- Patients must be at least 18 years of age on day of signing informed consent.
- Have a performance status of 0 or 1 on the ECOG Performance Scale. An ECOG performance status of 2 is acceptable if the patient was ECOG 0/1 prior to curative intent therapy and is in the midst of recovery from curative intent therapy.
- Demonstrate reasonable organ function as defined below in Table below
- System and Laboratory Value
- Hematological
- Absolute neutrophil count (ANC): ≥1,500 /mcL
- Platelets: ≥100,000 / mcL
- Hemoglobin: ≥9 g/dL
- Renal
- Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤2.0 X upper limit of normal (ULN) OR ≥30 mL/min for subject with creatinine levels > 2.0 X institutional ULN
- Hepatic
- Serum total bilirubin: ≤ 3 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 2 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- WOCBP must have a negative serum (beta-hCG) at screening.
- WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy.
- Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.
- Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.
- WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment.
- All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.
Who cannot join
- Clinical or radiographic evidence of gross disease that warrants further curative intent therapy or systemic/palliative therapy (e.g. platinum containing chemotherapy, cetuximab, pembrolizumab).
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10mg of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 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.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation 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 a previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy or typical side effects from radiotherapy are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
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- Patients who are receiving any other investigational agents.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment (e.g. low grade prostate cancer in absence of therapy).
- Exclusions related to infection or immunodeficiency
- History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
- Active infection requiring therapy.
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
- Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
- Notes:
- Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
- Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
- Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
- Patients with HIV or hepatitis must be reviewed by a qualified specialist (eg, infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial
- Known hypersensitivity to the active substances or to any of the excipients.
- Received a live vaccine within 30 days of planned start of study medication.
- o Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Exclusions related to cardiac conditions:
- Participants with a history of myocarditis.
- TnT or troponin I TnI > 2x institutional ULN at baseline.
- Patients with TnT or TnI levels between > 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are > 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.
- 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.
- Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
- Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;
- Intrauterine device; intrauterine hormone-releasing system;
- Bilateral tubal occlusion/ligation;
- Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or
- Sexual abstinence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ari Rosenberg, arirosenberg@bsd.uchicago.edu
About this study
Official title: A Randomized Phase II Trial of Cemiplimab With or Without Fianlimab in Patients With Detectable Minimal-residual Disease After Definitive Treatment for Human Papillomavirus Positive HPV(+) Head and Neck Cancer.
The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer who have detectable minimal-residual disease after definitive treatment. The main question(s) it aims to answer are:
- Does combining cemiplimab with fianlimab provide better results in preventing cancer recurrence than cemiplimab alone?
- Is the combination treatment safe and well-tolerated by patients? Researchers will compare the group receiving cemiplimab alone to the group receiving the combination of cemiplimab and fianlimab to see if the combination leads to improved treatment outcomes, such as better disease control and longer survival.
Read more
Participants will:
- Receive either cemiplimab alone or a combination of cemiplimab and fianlimab.
- Attend regular follow-up visits for monitoring of treatment efficacy and side effects.
- Undergo assessments to measure disease progression and response to treatment.
- Conditions
- Head and Neck Cancer
- Being tested
- cemiplimab+fianlimab, Cemiplimab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cemiplimab+fianlimabDrug
Fianlimab 1600 mg + Cemiplimab 350 mg FDC
CemiplimabDrug
350 mg
| Study group | Role | What they receive |
|---|---|---|
| two monoclonal antibodies together for 1 year | Experimental | This arm is assigned to intervention 1 Receives: Drug: cemiplimab+fianlimab |
| One monoclonal antibody alone for 1 year | Experimental | This arm is assigned to intervention 2 Receives: Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess improved recurrence free survival in patients
The primary objective is to assess whether cemiplimab with fianlimab compared to cemiplimab alone will result in improved recurrence free survival in patients with detectable MRD after definitive treatment for Human Papillomavirus Positive HPV(+) head and neck cancer.
Measured: assessed up to 5 years after enrollment completed
Secondary outcomes (4)
Recurrence free survival (RFS) improvement of cemiplimab with or without fianlimab
To assess whether cemiplimab with or without fianlimab will improve recurrence free survival (RFS) compared with a historical control of surveillance alone in patients with detectable MRD following definitive treatment for Human Papillomavirus Positive HPV(+) head and neck cancer.
Measured: assessed up to 5 years after enrollment completed
Assess improved circulating tumor Human Papillomavirus Positive HPV-DNA clearance rate
To assess whether cemiplimab plus fianlimab compared with cemiplimab alone will result in improved circulating tumor Human Papillomavirus Positive HPV-DNA clearance rate in patients with detectable MRD following definitive treatment for HPV(+) head and neck cancer.
Measured: 2 years after start of study
Compare patterns of disease recurrence and survival
To compare patterns of disease recurrence and survival between cemiplimab plus fianlimab versus cemiplimab alone in patients with detectable MRD following definitive treatment for Human Papillomavirus Positive HPV(+) head and neck cancer.
Measured: assessed up to 5 years after enrollment completed
Assess safety and tolerability of cemiplimab plus fianlimab
To assess the safety and tolerability of cemiplimab plus fianlimab in patients with detectable MRD following definitive treatment for Human Papillomavirus Positive HPV(+) head and neck cancer.
Measured: assessed up to 5 years after enrollment completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start9 Jun 2026
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ari Rosenberg, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179315
- Sponsor's protocol ID
- IRB25-0846
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Cemiplimab With or Without Fianlimab in Patients With Detectable Minimal-residual Disease After Definitive Treatment for Human Papillomavirus Positive HPV(+) Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT07179315
- Acronym / sponsor ID
- IRB25-0846
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer who have detectable minimal-residual disease after definitive treatment. The main question(s) it aims to answer are:
- Does combining cemiplimab with fianlimab provide better results in preventing cancer recurrence than cemiplimab alone?
- Is the combination treatment safe and well-tolerated by patients? Researchers will compare the group receiving cemiplimab alone to the group receiving the combination of cemiplimab and fianlimab to see if the combination leads to improved treatment outcomes, such as better disease control and longer survival.
Participants will:
- Receive either cemiplimab alone or a combination of cemiplimab and fianlimab.
- Attend regular follow-up visits for monitoring of treatment efficacy and side effects.
- Undergo assessments to measure disease progression and response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two monoclonal antibodies together for 1 year | Experimental | Drug: cemiplimab+fianlimabThis arm is assigned to intervention 1 |
| One monoclonal antibody alone for 1 year | Experimental | Drug: CemiplimabThis arm is assigned to intervention 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Patients must have history of histologically confirmed squamous cell carcinoma of the oropharynx.
- Must be HPV positive; testing must be compliant with meeting any one or more of the following criteria:
- p16 IHC positivity (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al.37).
- HPV PCR positivity.
- HPV in situ hybridization (ISH) positivity.
Key exclusion criteria (34 listed)
- Clinical or radiographic evidence of gross disease that warrants further curative intent therapy or systemic/palliative therapy (e.g. platinum containing chemotherapy, cetuximab, pembrolizumab).
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10mg of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 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.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation 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 a previously administered agent.
- Patients who are receiving any other investigational agents.
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 |
|---|---|---|
| cemiplimab+fianlimabFianlimab 1600 mg + Cemiplimab 350 mg FDC | Drug | two monoclonal antibodies together for 1 year |
| Cemiplimab350 mg | Drug | One monoclonal antibody alone for 1 year |
Primary outcome
Assess improved recurrence free survival in patients
Time frame: assessed up to 5 years after enrollment completed
The primary objective is to assess whether cemiplimab with fianlimab compared to cemiplimab alone will result in improved recurrence free survival in patients with detectable MRD after definitive treatment for Human Papillomavirus Positive HPV(+) head and neck cancer.
4 secondary outcomes
Recurrence free survival (RFS) improvement of cemiplimab with or without fianlimab
Time frame: assessed up to 5 years after enrollment completed
Assess improved circulating tumor Human Papillomavirus Positive HPV-DNA clearance rate
Time frame: 2 years after start of study
Compare patterns of disease recurrence and survival
Time frame: assessed up to 5 years after enrollment completed
Assess safety and tolerability of cemiplimab plus fianlimab
Time frame: assessed up to 5 years after enrollment completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ari Rosenberg study chair
University of Chicago
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 cemiplimab+fianlimab and Cemiplimab in people with Head and Neck Cancer, run by University of Chicago 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 32 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 16 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Center Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess improved recurrence free survival in patients (time frame: assessed up to 5 years after enrollment completed). 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 16 Jul 2026.