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New treatment option for Locally Advanced Nasopharyngeal Carcinoma
Official title Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT04910347
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced nasopharyngeal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The clinical efficacy of nivolumab for locally advanced nasopharyngeal carcinoma patients with residual disease after standard chemoradiotherapy is not known. In this study, we aim to investigate the role of nivolumab in locally advanced NPC after chemoradiotherapy the safety profile and antitumor activity of the anti-programmed death 1 (PD-1) receptor monoclonal antibody, nivolumab after in patients with advanced nasopharyngeal carcinoma
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, men only
You may be able to join if
- Male or female
- Age (at the time of informed consent): 19 years and older
- people with histologically- or cytologically-confirmed advanced Nasopharyngeal cancer (Stage II -IVa) according to 8th edition clinical staging...
- Patients who have recovered from previous toxicities of standard chemoradiotherapy (Grade ≤1).
- ECOG (Eastern Cooperative Oncology Group) Performance Status Score 0 or 1
You likely can't join if
- Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in...
- Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product...
- 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...
- Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
See the full eligibility criteria
Who can join
- Male or female
- Age (at the time of informed consent): 19 years and older
- people with histologically- or cytologically-confirmed advanced Nasopharyngeal cancer (Stage II -IVa) according to 8th edition clinical staging system of the American Joint Committee on Cancer before the start of...
- Patients who have recovered from previous toxicities of standard chemoradiotherapy (Grade ≤1).
- ECOG (Eastern Cooperative Oncology Group) Performance Status Score 0 or 1
- Patients with a life expectancy of at least 3 months
- Patients whose latest laboratory data meet the below criteria within 7 days before registration. If the date of the laboratory tests at the time of registration is not within 7 days before the first dose of the...
- 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
- 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...
- 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.
- 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...
- 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...
What rules you out
- 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...
- 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 assigned by chance if the radiation...
- 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 assigned by chance 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 a transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before registration
- Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
- Myocardial infarction within 180 days before registration
- Uncontrollable angina pectoris within 180 days before registration
- 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 receiving or requiring anticoagulant therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may be enrolled.
- Patients with uncontrollable diabetes mellitus
- Patients with systemic infections requiring treatment
- Patients who have received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before registration
- Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) within 28 days before registration
- Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before registration
- Patients who have undergone surgery under general anesthesia within 28 days before registration
- Patients who have undergone surgery involving local or topical anesthesia within 14 days before registration
- Patients who have received radiotherapy within 28 days before registration, or radiotherapy to bone metastases within 14 days before registration
- Patients who have received any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 56 days before registration
- 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 (except if HCV-RNA negative)
- 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 registration
- 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...
- 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 people of this study
- Patient with current or past history of hypersensitivity to Nivolumab.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.