A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or M… (NCT04603248) | Clinical Trial Compass
CompletedNot Applicable
A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
South Korea50 participantsStarted 2020-12-03
Plain-language 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 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Explore the biomarkers to predict objective response (OR)
Timeframe: Screening
2
Explore the biomarkers to predict objective response (OR)
Timeframe: Before Cycle2 Day1 (each cycle is 14 days)
3
Explore the biomarkers to predict objective response (OR)
Timeframe: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
4
Explore the biomarkers to predict progression-free survival (PFS)
Timeframe: Screening
5
Explore the biomarkers to predict progression-free survival (PFS)
Timeframe: Before Cycle2 Day1 (each cycle is 14 days)
6
Explore the biomarkers to predict progression-free survival (PFS)
Timeframe: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months
. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
. Patients with a life expectancy of at least 3 months
Exclusion criteria
. 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
. 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
Explore the biomarkers to predict overall survival (OS)
Timeframe: Screening
8
Explore the biomarkers to predict overall survival (OS)
Timeframe: Before Cycle2 Day1 (each cycle is 14 days)
9
Explore the biomarkers to predict overall survival (OS)
Timeframe: From date of randomization until the date of first documented progression or date of unacceptable toxicity, whichever came first, assessed up to 100 months