Head and Neck CancerPhase 1NCT07216833

Decitabine and Nivolumab in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 1 study testing Decitabine and Nivolumab in people with Head and Neck Cancer and Head and Neck Neoplasms, run by Case Comprehensive Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
What is being tested?: Decitabine and Nivolumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Jan 2026to 31 Dec 2027
Phase: Phase 1
Are there results?: None posted in the registry

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

Participants must have histologically or cytologically confirmed recurrent or metastatic HNSCC considered incurable by local therapies and eligible to receive anti-PD-L1 as first-line treatment (PD-L1 positive with combined positive score (CPS) 1 as evaluated in pre-screening).
Participants must have primary tumor locations in following; oral cavity, oropharynx, hypopharynx, or larynx (nasopharynx is not allowed).
No systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy completed within 6 months or > 6 months if given as part of multimodal treatment for locally advanced disease).
Participants must not have received prior treatment with immune checkpoint inhibitors.
For primary site locally recurrent HNSCC, participants can provide archival tumor tissue not older than 3 months from a core or excisional biopsy for PD-L1 pre-screening using the PD-L1 IHC 22C3 pharmDx assay.
For metastatic cancer patients, archival tumor tissue of distant metastatic lesion should not be older than 3 months from a core biopsy for PD-L1 pre-screening using the PD-L1 IHC 22C3 pharmDx assay.

Show all 20Show fewer

For primary site locally recurrent HNSCC, participants must have lesions amenable to obtain pre-treatment tumor biopsies in screening period after eligibility confirmation and before start of treatment and on-treatment tumor biopsies on C1D8 \& C3D21 after start of treatment if lesions are still present at that time. If a recent archival biopsy is obtained within 3 months prior to start of treatment, this biopsy can be used as a pre-treatment biopsy.
Participants should be ≥ 18 years of age
Participants should have ECOG Performance status ≤ 2
Participants must have normal organ and marrow function as defined below:
Hemoglobin ≥ 9.0 g/dl
Leukocytes ≥ 3,000/mcL
Absolute neutrophil count ≥ 1,500/mcL
Platelet count ≥ 100,000/mcL
Total bilirubin within normal institutional limits (Gilbert's syndrome related elevated bilirubin is accepted as long as levels have been stable within last 3 months).
AST (SGOT) ≤ 2.5 X institutional upper limit of normal
ALT (SGPT) < 2.5 X institutional upper limit of normal
Serum creatinine within normal institutional limits
Women of child-bearing potential and sexually active men with female partners of child-bearing potential must agree to use a highly effective method of contraception beginning with the first dose of study therapy and for the duration of their participation in the study. This is expected for the entire duration of the study period through 6 months after the last dose. Highly effective methods of contraception include female sterilization (tubal ligation, bilateral oophorectomy, and/or hysterectomy); male sterilization (at least 6 months prior to screening); intrauterine device; and oral, injected, or implanted hormonal contraception AND barrier methods of contraception. Women of child-bearing potential must have documented negative pregnancy test prior to start of investigational treatment regimen. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Participants must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

Participants with progressive disease within six months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
Participants with history of severe immune related adverse effects from prior immunotherapy, except hypothyroidism clinically stable on hormone replacement treatment and controlled type 1 diabetes. All other endocrinopathies are excluded even if controlled with medications.
Participants with Grade ≥ 3 infections within 4 weeks before the first study drug administration. Clinically active infections > Grade 1 within 2 weeks before the first study drug administration.
Participants with previous or active myocarditis/myositis in history (independent of cause).
Participants with pneumonitis, idiopathic pulmonary fibrosis, organizing, interstitial lung disease active or history of autoimmune disease. Autoimmune thyroid disease as well as other non-life-threatening autoimmune diseases such as vitiligo or autoimmune alopecia that don't require systemic immunosuppression are not excluded.
Participants with known human immunodeficiency virus (HIV) infection, uncontrolled active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Show all 13Show fewer

Participants with treatment with systemic immunosuppressant medications within 2 weeks before the first study drug administration. However, low-dose steroid use (prednisone equivalent <=10 mg daily) for other reasons is allowed.
Participants receiving any other investigational agents.
Participants with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Participants with confirmed COVID-19. Participants with confirmed COVID-19 within 7 days prior to starting treatment will be excluded, however upon recovery with confirmation of negative COVID test, participant can be reconsidered for the study.
Participants with a history of hypersensitivity to active or inactive excipients of decitabine or nivolumab or drugs with a similar chemical structure or class to either agent.
Participants with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Biomarker Driven Phase 1/1b Trial of Decitabine and Nivolumab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

This research study is for people who have recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has been confirmed by tissue or cell analysis and is considered incurable with local treatments. People who are eligible to receive anti-PD-L1 therapy as a first line treatment and whose primary tumor is located in the oral cavity, oropharynx, hypopharynx, or larynx, may be eligible to participate.

The purpose of this study is to evaluate the immunogenicity of decitabine in combination with nivolumab, and to evaluate the safety and tolerability of decitabine in combination with nivolumab and to determine the maximum tolerated dose.

Decitabine is a drug that is currently approved by the Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS). Decitabine is considered an investigational (experimental) drug in this study because it is not approved by the FDA for the treatment of HNSCC. Decitabine is a chemotherapy drug that works by targeting DNA methylation, a process that can restore normal function to genes that are involved in cell growth and differentiation. This can help reduce the growth of cancer cells.

Nivolumab is a drug that is approved by the FDA for the treatment of HNSCC, as well as other types of cancer. Nivolumab is an immunotherapy drug that works by helping the body's immune system recognize and attack cancer cells.

Read the detailed description

Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide with approximately 60,000 people diagnosed each year in the United States. People with human papilloma virus (HPV)-positive HNSCC usually have a good prognosis, but HPV-negative people have about a 50% chance that their cancer will come back even after being treated. People who have recurrent or metastatic (R/M) HNSCC who are treated for their cancer tend to have an even worse prognosis, with a median overall survival of about 10 months. An anti-programmed-death-1 (anti-PD1) inhibitor called pembrolizumab was recently approved to treat people with R/M HNSCC. Another type of anti-PD1 inhibitor is a drug called nivolumab, which is also approved to treat people with R/M HNSCC. However, response rates to both pembrolizumab and nivolumab monotherapy are as low as 19% and 13.3% respectively. This shows that there are immune-evasive mechanisms present, meaning that tumor cells can more easily evade being detected and destroyed. Decitabine is a drug that may help anti-PD1 inhibitors like nivolumab better detect and destroy tumor cells. Previous research has shown that using a DNA methyltransferase inhibitor before giving a PD1 inhibitor to treat cancer can help the body's immune system more effectively kill cancer cells. Decitabine is a drug that is a type of DNA methyltransferase inhibitor. The purpose of this study is to evaluate the safety and tolerability of using decitabine in combination with nivolumab to treat HNSCC.

Conditions: Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
Being tested: Decitabine, Nivolumab
Keywords: Decitabine and Nivolumab
Medical subject headings: Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DecitabineDrug
Participants will receive dose level 1 (DL1). If 2 of 3 participants experience dose limiting toxicity (DLT) on DL1, then the dose will be de-escalated to DL1-1. If 2 of 3 participants experience DLT on DL1-1, then no further de-escalation will occur and no additional participants will be enrolled.
DL1: Intravenous (IV) administration of decitabine 20 mg/m2 from Days 1-5
DL1-1: Intravenous (IV) administration of decitabine 20 mg/m2 from Days 1-4
NivolumabDrug
Nivolumab will be used as a fixed dose in combination with de-escalating dose levels (DL1, DL1-1) of decitabine.
Participants will receive 480 mg of nivolumab on Day 8 every 4-week cycle.

Study groups in NCT07216833
Study group	Role	What they receive
Decitabine + Nivolumab	Experimental	Participants will receive 28-day cycles of decitabine followed by nivolumab for up to 35 cycles (up to 2 years) or until disease progression or other adverse event(s). Receives: Drug: Decitabine; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacodynamics data on the effects of decitabine, as measured by change in global DNA methylation status
DNA methylation will be measured pre- and post-decitabine administration and will be compared using Wilcoxon signed-rank test. Methylation analysis requires 500ng of isolated DNA and will be performed on the Illumina Infinium EPIC array.
Measured: Day 1, Day 8
Immunogenicity of decitabine in combination with nivolumab, as measured by change in immunologic biomarkers
Changes in immunologic biomarkers will be correlated with changes in DNA methylation, measured pre- and post-decitabine administration. Immunologic biomarkers include PD-L1 expression (IHC), HLA Class I protein expression (IHC), TIL (tumor infiltrating lymphocytes, IHC and multiplex IF).
Measured: Day 1, Day 8
Safety and tolerability of decitabine in combination with nivolumab, as measured by number of adverse events
Participants will be evaluated for safety with a follow up visit approximately 28 (+/- 7) days after treatment discontinuation. The National Cancer Institute Common Terminology Criteria for Advanced events (NCI CTCAE) version 5 will be used for adverse event grading. Safety evaluation will be measured by reviewing the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring.
Measured: Up to 35 days post-treatment discontinuation (treatment may last up to 2 years)
Maximum tolerated dose (MTD)
MTD is defined as the dose level at which safety can be confirmed. If 2 or more out of 3 participants experienced a dose limiting toxicity (DLT), the dose will be de-escalated and evaluated for safety. MTD will be evaluated through the treatment period. Participants will receive treatment of up to 35 treatment cycles until disease progression or other adverse event(s).
Measured: Through treatment period, up to 35 cycles (each cycle is 28 days) or up to 2 years

Secondary outcomes (2)

Objective response rate (ORR)
ORR is the percentage of participants whose cancer got better after treatment (i.e. the percentage of participants who had CR or PR, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: End (week 4) of every 3 cycles, up to 35 total cycles (each cycle is 28 days) or up to 2 years
Overall survival (OS)
Overall survival (OS) is defined as the duration of time from start of treatment to time of death from any cause.
Measured: Until death, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 202631 Dec 2027

First posted15 Oct 2025
Study startJan 2026 (estimated)
Primary completion31 Jul 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Why it stopped: PI leaving the institution

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Head and Neck CancerStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07216833
Sponsor's protocol ID: CASE7324
Status last verified: Jun 2026
First submitted: 8 Oct 2025
Last updated: 22 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All collected IPD that underline results in publication

Publications

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902
Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
PubMed 20530316
Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.
PubMed 18784101
Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.
PubMed 31679945
Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
PubMed 27718784
Ghoneim HE, Fan Y, Moustaki A, Abdelsamed HA, Dash P, Dogra P, Carter R, Awad W, Neale G, Thomas PG, Youngblood B. De Novo Epigenetic Programs Inhibit PD-1 Blockade-Mediated T Cell Rejuvenation. Cell. 2017 Jun 29;170(1):142-157.e19. doi: 10.1016/j.cell.2017.06.007. Epub 2017 Jun 22.
PubMed 28648661
Pauken KE, Sammons MA, Odorizzi PM, Manne S, Godec J, Khan O, Drake AM, Chen Z, Sen DR, Kurachi M, Barnitz RA, Bartman C, Bengsch B, Huang AC, Schenkel JM, Vahedi G, Haining WN, Berger SL, Wherry EJ. Epigenetic stability of exhausted T cells limits durability of reinvigoration by PD-1 blockade. Science. 2016 Dec 2;354(6316):1160-1165. doi: 10.1126/science.aaf2807. Epub 2016 Oct 27.
PubMed 27789795

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Head and Neck Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biomarker Driven Phase 1/1b Trial of Decitabine and Nivolumab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
ClinicalTrials.gov ID: NCT07216833
Acronym / sponsor ID: CASE7324
Conditions: Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
Keywords: Decitabine and Nivolumab
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: PI leaving the institution
Enrolment: 0 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Study start: Jan 2026 (estimated)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 15 Oct 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Decitabine + Nivolumab	Experimental	Drug: Decitabine, Drug: NivolumabParticipants will receive 28-day cycles of decitabine followed by nivolumab for up to 35 cycles (up to 2 years) or until disease progression or other adverse event(s).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Participants must have histologically or cytologically confirmed recurrent or metastatic HNSCC considered incurable by local therapies and eligible to receive anti-PD-L1 as first-line treatment (PD-L1 positive with combined positive score (CPS) 1 as evaluated in pre-screening).
Participants must have primary tumor locations in following; oral cavity, oropharynx, hypopharynx, or larynx (nasopharynx is not allowed).
No systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy completed within 6 months or > 6 months if given as part of multimodal treatment for locally advanced disease).
Participants must not have received prior treatment with immune checkpoint inhibitors.
For primary site locally recurrent HNSCC, participants can provide archival tumor tissue not older than 3 months from a core or excisional biopsy for PD-L1 pre-screening using the PD-L1 IHC 22C3 pharmDx assay.

Key exclusion criteria (13 listed)

Participants with progressive disease within six months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
Participants with history of severe immune related adverse effects from prior immunotherapy, except hypothyroidism clinically stable on hormone replacement treatment and controlled type 1 diabetes. All other endocrinopathies are excluded even if controlled with medications.
Participants with Grade ≥ 3 infections within 4 weeks before the first study drug administration. Clinically active infections > Grade 1 within 2 weeks before the first study drug administration.
Participants with previous or active myocarditis/myositis in history (independent of cause).
Participants with pneumonitis, idiopathic pulmonary fibrosis, organizing, interstitial lung disease active or history of autoimmune disease. Autoimmune thyroid disease as well as other non-life-threatening autoimmune diseases such as vitiligo or autoimmune alopecia that don't require systemic immunosuppression are not excluded.

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
DecitabineParticipants will receive dose level 1 (DL1). If 2 of 3 participants experience dose limiting toxicity (DLT) on DL1, then the dose will be de-escalated to DL1-1. If 2 of 3 participants experience DLT on DL1-1, then no further de-escalation will occur and no additional participants will be enrolled. DL1: Intravenous (IV) administration of decitabine 20 mg/m2 from Days 1-5 DL1-1: Intravenous (IV) administration of decitabine 20 mg/m2 from Days 1-4	Drug	Decitabine + Nivolumab
NivolumabNivolumab will be used as a fixed dose in combination with de-escalating dose levels (DL1, DL1-1) of decitabine. Participants will receive 480 mg of nivolumab on Day 8 every 4-week cycle.	Drug	Decitabine + Nivolumab

Primary outcome

Pharmacodynamics data on the effects of decitabine, as measured by change in global DNA methylation status
Time frame: Day 1, Day 8
DNA methylation will be measured pre- and post-decitabine administration and will be compared using Wilcoxon signed-rank test. Methylation analysis requires 500ng of isolated DNA and will be performed on the Illumina Infinium EPIC array.
Immunogenicity of decitabine in combination with nivolumab, as measured by change in immunologic biomarkers
Time frame: Day 1, Day 8
Changes in immunologic biomarkers will be correlated with changes in DNA methylation, measured pre- and post-decitabine administration. Immunologic biomarkers include PD-L1 expression (IHC), HLA Class I protein expression (IHC), TIL (tumor infiltrating lymphocytes, IHC and multiplex IF).
Safety and tolerability of decitabine in combination with nivolumab, as measured by number of adverse events
Time frame: Up to 35 days post-treatment discontinuation (treatment may last up to 2 years)
Participants will be evaluated for safety with a follow up visit approximately 28 (+/- 7) days after treatment discontinuation. The National Cancer Institute Common Terminology Criteria for Advanced events (NCI CTCAE) version 5 will be used for adverse event grading. Safety evaluation will be measured by reviewing the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring.
Maximum tolerated dose (MTD)
Time frame: Through treatment period, up to 35 cycles (each cycle is 28 days) or up to 2 years
MTD is defined as the dose level at which safety can be confirmed. If 2 or more out of 3 participants experienced a dose limiting toxicity (DLT), the dose will be de-escalated and evaluated for safety. MTD will be evaluated through the treatment period. Participants will receive treatment of up to 35 treatment cycles until disease progression or other adverse event(s).

2 secondary outcomes

Objective response rate (ORR)
Time frame: End (week 4) of every 3 cycles, up to 35 total cycles (each cycle is 28 days) or up to 2 years
Overall survival (OS)
Time frame: Until death, up to 2 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
Background: PubMed 20530316Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
Background: PubMed 18784101Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.
Background: PubMed 31679945Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.
Background: PubMed 27718784Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
Background: PubMed 28648661Ghoneim HE, Fan Y, Moustaki A, Abdelsamed HA, Dash P, Dogra P, Carter R, Awad W, Neale G, Thomas PG, Youngblood B. De Novo Epigenetic Programs Inhibit PD-1 Blockade-Mediated T Cell Rejuvenation. Cell. 2017 Jun 29;170(1):142-157.e19. doi: 10.1016/j.cell.2017.06.007. Epub 2017 Jun 22.
Background: PubMed 27789795Pauken KE, Sammons MA, Odorizzi PM, Manne S, Godec J, Khan O, Drake AM, Chen Z, Sen DR, Kurachi M, Barnitz RA, Bartman C, Bengsch B, Huang AC, Schenkel JM, Vahedi G, Haining WN, Berger SL, Wherry EJ. Epigenetic stability of exhausted T cells limits durability of reinvigoration by PD-1 blockade. Science. 2016 Dec 2;354(6316):1160-1165. doi: 10.1126/science.aaf2807. Epub 2016 Oct 27.
Individual participant dataSharing planned: Yes. All collected IPD that underline results in publication

Related trials for Head and Neck Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

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.

Kyunghee Burkitt, DO, PhD, MS principal investigator

Case Comprehensive Cancer Center, Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Decitabine and Nivolumab in people with Head and Neck Cancer and Head and Neck Neoplasms, run by Case Comprehensive Cancer Center 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 20 inclusion and 13 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: withdrawn, as of the sponsor's last update on 22 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Pharmacodynamics data on the effects of decitabine, as measured by change in global DNA methylation status (time frame: Day 1, Day 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07216833, which also lists 7 linked publications.

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 22 Jun 2026.