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โ† Trials
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Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

RecruitingPhase 2Ages 18 Years - anyAllNational Cancer Institute (NCI)
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In plain words

What the trial is, and whether it could suit you

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin wo

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION: * Pathologically (histologically or cytologically) proven diagnosis of nasopharyngeal carcinoma (NPC) that has recurred locoregionally and/or is present at distant sites. Patients who present with metastatic disease (de novo) at diagnosis are also eligible. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation. Eligible patient must have the following characteristics: * Tumor showing (histological/cytological) Epstein-Barr encoded ribonucleic acid (EBER)-positivity (e.g., In situ hybridization, immunohistochemistry) or * A known history of detectable plasma EBV DNA (via a polymerase chain reaction \[PCR\]-based assay) at any time point since the initial diagnosis of NPC. * Measurable disease as defined by RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression after the prior radiation therapy has been demonstrated. * Contrast enhanced CT scan of the chest. The contrast enhanced CT component of a whole-body PET-CT is also acceptable. The plain (non-contrast) CT component of a PET-CT is not acceptable. * CT the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated). * Patients with known locoregional disease must have contrast enhanced MRI or CT of the nasopharynx and neck as this disease site(s) may be assessed as target lesions. For patients without known locoregional disease, imaging of the nasopharynx and neck is optional. * Symptomatic and active brain metastases and/or leptomeningeal metastasis on CT and/or MRI imaging: Patients who have prior therapies for brain and leptomeningeal metastasis or cord/cauda compression who are clinically stable for \>= 2 months prior to registration and have discontinued systemic steroids therapy (\> 10 mg/day prednisone or equivalent) \> 4 weeks prior to registration are eligible. * Patients with base of skull involvement by NPC are allowed unless their disease is directly invading the brain parenchyma, associated with clinical symptoms and/or significant vasogenic edema on radiological imaging. * Age \>= 18 years. * Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2. * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. * Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3. * Platelets \>= 100,000 cells/mm\^3. * Hemoglobin (Hgb) \>= 8.0 g/dL (Transfusion is accepted. Erythropoietin dependency not accepted.). * Total bilirubin =\< 1.5 ร— institutional upper limit of normal (ULN) or direct bilirubin =\< ULN for patients with total bilirubin levels \> 1.5 ร— ULN. Patients with known Gilbert's disease who have serum bilirubin level =\< 3 ร— ULN may be enrolled. * Alanine transaminase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 ร— ULN (=\< 5 ร— ULN for patients with liver metastases). * Serum creatinine =\< 1.5 ร— ULN or calculated creatinine clearance (CrCl) based on Cockcroft-Gault equation \>= 30 mL/min for patients with serum creatinine levels \> 1.5 ร— ULN. Cisplatin or carboplatin may be used at the discretion of the investigator - except for patients with CrCl between 30-50 mL/min, for whom carboplatin should be used instead of cisplatin. CrCl must be \> 50 mL/min for cisplatin to be used. * Albumin-adjusted calcium level based on corrected calcium equation =\< 1.5 ร— ULN (patients are allowed to have treatment for hypercalcemia prior to starting treatment). * No prior systemic treatment of palliative intent for recurrent/metastatic (R/M) NPC including cytotoxic chemotherapy. Prior treatment for non-recurrent and non-metastatic NPC is allowed. Systemic therapy given prior to curative intent re-irradiation or surgery is allowed for potentially curable locoregional recurrence. * No prior treatment with a PD-1 inhibitor (except if given as adjuvant or neoadjuvant therapy for NPC), PD-L1 inhibitor, anti-PD-L2 inhibitor, LAG-3 inhibitor, CTLA-4 inhibitor (except if given as adjuvant or neoadjuvant therapy for non-recurrent and non-metastatic NPC), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. * The interval between the last dose of curative-intent treatment for non-recurrent, non-metastatic NPC, including definitive radiotherapy (RT) and/or induction, concurrent, or adjuvant chemotherapy and recurrence must be หƒ 6 months. * Clinically significant toxicities from any prior systemic therapy or radiotherapy must have resolved to grade 0 or 1 as per National Cancer Institute (NCI) CTCAE v 5.0 - except alopecia, dry mouth, dysgeusia, dysphagia, and fatigue. Patients with a history of grade 3-4 cisplatin related neuropathy must have recovered to grade 0-2 prior to registration. Patients with a history of hearing impairment, or ototoxicity from prior cisplatin, of any grade are allowed. * No prior palliative RT within 30 days prior to registration unless the irradiated site(s) are not the target lesions. The irradiated site(s) also must not be the only sites of measurable recurrent disease. * No major surgical procedures within 30 days prior to registration. * No history of unstable angina requiring hospitalization within the last 6 months. * No history of myocardial infarction within the last 6 months. * New York Heart Association Functional Classification II or better (New York Heart Association \[NYHA\] Functional Classification III/IV are not eligible). Patients with symptomatic coronary artery disease, congestive heart failure or a known history of having a left ventricular ejection fraction \< 50% must be stably controlled with medication in the opinion of
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What it tests

  • Biospecimen Collection
  • Bone Scan
  • Carboplatin
  • Cisplatin
  • Computed Tomography
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Where

95 sites
Kaiser Permanente Dublin
Dublin, United States
Kaiser Permanente-Fremont
Fremont, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, United States
Kaiser Permanente-Fresno
Fresno, United States
Keck Medicine of USC Koreatown
Los Angeles, United States
Los Angeles General Medical Center
Los Angeles, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, United States
Kaiser Permanente- Modesto MOB II
Modesto, United States

โ€ฆand 87 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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