Head and Neck Squamous Cell Carcinoma (HNSCC)NCT04603248
A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
A study testing Nivolumab in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Yonsei University at 1 site in South Korea.
Trial summary
A study for identification of immune determinants for response to Nivolumab in Recurrent /Metastatic HNSCC(Head and neck squamous cell carcinoma) patients. Recurrent and metastatic head and neck squamous cell carcinoma is incurable and requires aggressive treatment, resulting in functional disability, dismal… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Dec 2020to 18 Mar 2026
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: Male or female
- Age (at the time of informed consent): 19 years and older
- Subjects with histologically- or cytologically-confirmed recurrent and/or metastatic head and neck squamous cell carcinoma (Recurrent/Metastatic HNSCC)
- Known human papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization
- Failed or intolerable to previous platinum-based chemotherapy
- Patients who have at least 1 measurable or non-measurable lesion per the RECIST (Response Evaluation Criteria in Solid Tumor) Guideline Ver. 1.1 as confirmed by imaging within 28 days before enrollment. The following requirements should also be satisfied:
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- If patients only have lesions that were previously treated with radiation, the lesion should be limited to one with confirmed aggravation by imaging after radiation.
- If patients have pericardial or pleural effusion or ascites only, the lesion should be limited to one with cytologically confirmed malignancy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Patients with a life expectancy of at least 3 months
- Screening laboratory values within the specified ranges stated below, obtained within 14 days prior to first dose:
- White blood cells ≥2,000/mm3 and neutrophils ≥1,500/mm3
- Platelets ≥100,000/mm3
- Hemoglobin ≥9.0 g/dL
- AST (GOT) and ALT (GPT) ≤3.0-fold the upper limit of normal (ULN) of the study site (or ≤5.0-fold the ULN of the study site in patients with liver metastases)
- Total bilirubin ≤1.5-fold the ULN of the study site
- Creatinine ≤1.5-fold the ULN of the study site or creatinine clearance (either the measured or estimated value using the Cockcroft-Gault equation) >45 mL/min
- Explicit and voluntary consent to participate in the study obtained using a signed and dated informed consent form clearly and fully describing the purpose, potential risks, and any other critical issues regarding the study
- Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons#1) must agree to use contraception(#2) from the time of informed consent until 5 months or more after the last dose of the investigational product. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product
- Men must agree to use contraception(#2) from the start of study treatment until 7 months or more after the last dose of the investigational product.
- #1 Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for ≥12 consecutive months without specific reasons. Women using oral contraceptives, intrauterine devices, or mechanical contraception such as contraceptive barriers are regarded as having childbearing potential.
- #2 The subject must consent to use any two of the following methods of contraception: vasectomy or condom for patients who are male or female subject's partner and tubal ligation, contraceptive diaphragm, intrauterine device, spermicide, or oral contraceptive for patients who are female or male subject's partner.
Who cannot join
- Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years)
- Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.
- Patients with current or past history of severe hypersensitivity to any other antibody products
- Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
- Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be enrolled if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.
- Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
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- Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment. Patients may be enrolled if the metastasis is asymptomatic and requires no treatment.
- Patients with pericardial fluid, pleural effusion, or ascites requiring treatment
- Patients with uncontrollable, tumor-related pain
- Patients who have experienced medically refractory transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before enrollment
- Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
- Myocardial infarction within 180 days before enrollment
- Uncontrollable angina pectoris within 180 days before enrollment
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥ 90 mmHg lasting 24 hours or more)
- Arrhythmia requiring treatment
- Patients with uncontrollable diabetes mellitus
- Patients with systemic infections requiring treatment with intravenous antibiotics
- Patients who have received systemic corticosteroids (more than 10mg/day prednisolone except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before enrollment
- Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) within 14 days before enrollment
- Patients who have undergone surgical adhesion of the pleura or pericardium within 14 days before enrollment
- Patients who have undergone surgery under general anesthesia within 14 days before enrollment
- Patients who have undergone surgery involving local or topical anesthesia within 7 days before enrollment
- Patients who have received radiotherapy within 14 days before enrollment, or radiotherapy to bone metastases within 7 days before enrollment
- Patients who have received any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 56 days before enrollment
- Patients with a positive test result for any of the following: HIV-1 antibody, HIV-2 antibody, HTLV-1 antibody, HBs antigen, or HCV antibody
- Patients with a negative HBs antigen test but a positive test result for either HBs antibody or HBc antibody with a detectable level of HBV-DNA
- Women who are pregnant or breastfeeding, or possibly pregnant
- Patients who have received any other unapproved drug (e.g., investigational use of drugs, unapproved combined formulations, or unapproved dosage forms) within 28 days before enrollment
- Patients who have previously received Nivolumab, anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody or other therapeutic antibodies or pharmacotherapies for regulation of T-cells
- Patients judged to be incapable of providing consent for reasons such as concurrent dementia
- Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study
- Patient with current or past history of hypersensitivity to Nivolumab.
Trial locations and contacts
1 site in 1 country.
About this study
A study for identification of immune determinants for response to Nivolumab in Recurrent /Metastatic HNSCC(Head and neck squamous cell carcinoma) patients.
Recurrent and metastatic head and neck squamous cell carcinoma is incurable and requires aggressive treatment, resulting in functional disability, dismal prognosis, and high mortality rate. Prognosis of Recurrent and metastatic head and neck squamous cell carcinoma is poor, with limited treatment options and survival rates of 6-9 months following standard-of-care (SOC) therapies. Clinical trials have demonstrated promising clinical activity of anti PD-1(programmed death-1) therapy in head and neck squamous cell carcinoma. Currently, nivolumab were approved for head and neck squamous cell carcinoma refractory to platinum-based therapy. However, the response rate of anti PD-1(programmed death-1) therapy is relatively low and durable clinical benefit is limited to the minority of patients. Moreover, the presence of PD-1(programmed death-1) did not clearly predict response and treatment survival outcome, reflecting imperfection of this biomarker. Actually, PD-1(programmed death-1) negativity cannot preclude the therapeutic benefit of PD-1(programmed death-1) blockade, and vice versa. Hence, development of reliable predictive biomarkers is essential for proper patient selection to maximize clinical benefit of PD-1(programmed death-1) blockade in head and neck squamous cell carcinoma patients.
Read more
Therefore, we need to select patients who are most likely to benefit from anti PD-1(programmed death-1) therapy and identify the better biomarker to predict the response to PD-1(programmed death-1) blockade in head and neck squamous cell carcinoma patients. patients earlier than tumor assessment by imaging scan.
In the current study, we aimed to elucidate immune-related biomarkers to predict response with tumor tissue and peripheral blood from Recurrent /Metastatic HNSCC(Head and neck squamous cell carcinoma) patients treated with nivolumab.
- Being tested
- Nivolumab
- Keywords
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Medical subject headings
- 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.
NivolumabDrug
Nivolumab 3mg/kg treatment will be given every 2 weeks up to progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the biomarkers to predict objective response (OR)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Microbiome, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: Screening
Explore the biomarkers to predict objective response (OR)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: Before Cycle2 Day1 (each cycle is 14 days)
Explore the biomarkers to predict objective response (OR)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
Explore the biomarkers to predict progression-free survival (PFS)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Microbiome, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: Screening
Explore the biomarkers to predict progression-free survival (PFS)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: Before Cycle2 Day1 (each cycle is 14 days)
Explore the biomarkers to predict progression-free survival (PFS)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
Explore the biomarkers to predict overall survival (OS)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Microbiome, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: Screening
Explore the biomarkers to predict overall survival (OS)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: Before Cycle2 Day1 (each cycle is 14 days)
Explore the biomarkers to predict overall survival (OS)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Measured: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
Secondary outcomes (1)
Safety: Number of participants with adverse events and abnormal laboratory values as assessed by NCI-CTCAE version 5
Number of participants with adverse events and abnormal laboratory values as assessed by NCI-CTCAE version 5
Measured: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start3 Dec 2020
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gon Kim, Yonsei University
- Investigators
- Hye Ryun Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603248
- Sponsor's protocol ID
- 4-2020-0801
- Status last verified
- Jun 2026
- First submitted
- 8 Oct 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04603248
- Acronym / sponsor ID
- 4-2020-0801
- Keywords
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 26 Oct 2020 (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.
A study for identification of immune determinants for response to Nivolumab in Recurrent /Metastatic HNSCC(Head and neck squamous cell carcinoma) patients.
Recurrent and metastatic head and neck squamous cell carcinoma is incurable and requires aggressive treatment, resulting in functional disability, dismal prognosis, and high mortality rate. Prognosis of Recurrent and metastatic head and neck squamous cell carcinoma is poor, with limited treatment options and survival rates of 6-9 months following standard-of-care (SOC) therapies. Clinical trials have demonstrated promising clinical activity of anti PD-1(programmed death-1) therapy in head and neck squamous cell carcinoma. Currently, nivolumab were approved for head and neck squamous cell carcinoma refractory to platinum-based therapy. However, the response rate of anti PD-1(programmed death-1) therapy is relatively low and durable clinical benefit is limited to the minority of patients. Moreover, the presence of PD-1(programmed death-1) did not clearly predict response and treatment survival outcome, reflecting imperfection of this biomarker. Actually, PD-1(programmed death-1) negativity cannot preclude the therapeutic benefit of PD-1(programmed death-1) blockade, and vice versa. Hence, development of reliable predictive biomarkers is essential for proper patient selection to maximize clinical benefit of PD-1(programmed death-1) blockade in head and neck squamous cell carcinoma patients.
Therefore, we need to select patients who are most likely to benefit from anti PD-1(programmed death-1) therapy and identify the better biomarker to predict the response to PD-1(programmed death-1) blockade in head and neck squamous cell carcinoma patients. patients earlier than tumor assessment by imaging scan.
In the current study, we aimed to elucidate immune-related biomarkers to predict response with tumor tissue and peripheral blood from Recurrent /Metastatic HNSCC(Head and neck squamous cell carcinoma) patients treated with nivolumab.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Nivolumab |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Sex: Male or female
- Age (at the time of informed consent): 19 years and older
- Subjects with histologically- or cytologically-confirmed recurrent and/or metastatic head and neck squamous cell carcinoma (Recurrent/Metastatic HNSCC)
- Known human papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization
- Failed or intolerable to previous platinum-based chemotherapy
Key exclusion criteria (33 listed)
- Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years)
- Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.
- Patients with current or past history of severe hypersensitivity to any other antibody products
- Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
- Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be enrolled if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.
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 |
|---|---|---|
| NivolumabNivolumab 3mg/kg treatment will be given every 2 weeks up to progression or unacceptable toxicity | Drug | Single Arm |
Primary outcome
Explore the biomarkers to predict objective response (OR)
Time frame: Screening
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Microbiome, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Explore the biomarkers to predict objective response (OR)
Time frame: Before Cycle2 Day1 (each cycle is 14 days)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Explore the biomarkers to predict objective response (OR)
Time frame: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Explore the biomarkers to predict progression-free survival (PFS)
Time frame: Screening
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Microbiome, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Explore the biomarkers to predict progression-free survival (PFS)
Time frame: Before Cycle2 Day1 (each cycle is 14 days)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Explore the biomarkers to predict progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Explore the biomarkers to predict overall survival (OS)
Time frame: Screening
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Microbiome, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Explore the biomarkers to predict overall survival (OS)
Time frame: Before Cycle2 Day1 (each cycle is 14 days)
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
Explore the biomarkers to predict overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
Single cell RNA sequencing (scRNA-seq), Multiplex IHC (Vectra Polaris®), T cell immunophenotyping using flow cytometry, papilloma virus (HPV) infection status with p16 immunohistochemistry or HPV in-situ hybridization, Evaluation of PD-L1 expression status based on combined positivity score and tumor rate score
1 secondary outcome
Safety: Number of participants with adverse events and abnormal laboratory values as assessed by NCI-CTCAE version 5
Time frame: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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. This study is not recruiting at the moment.
Hye Ryun Kim principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Yonsei University at 1 site in South Korea.
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 22 inclusion and 33 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 10 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Explore the biomarkers to predict objective response (OR) (time frame: Screening). The study lists 9 primary outcomes in all. 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 10 Jun 2026.