[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-squamous-cell-carcinoma-hnscc---recurrentmetastatic-rm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-squamous-cell-carcinoma-hnscc---recurrentmetastatic-rm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,83,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":4},"100644327","phase-1-a-phase-ii-trial-for-mor-antagonism-with-axelopran-to-enhance-immunotherapy-in-head-and-neck-cancer-100644327",false,"NCT07662720","A Phase II Trial for MOR Antagonism With Axelopran to Enhance Immunotherapy in Head and Neck Cancer","A Phase I\u002FII, Open-Label, Study to Assess the Safety, Tolerability, and Efficacy of Axelopran Administered With Standard of Care Pembrolizumab in Recurrent\u002FMetastatic HNSCC Patients Taking Opioids to Control Cancer Pain","MORALE-HN01","Inclusion Criteria: Individuals may be included in the trial only if they meet all of the following inclusion criteria prior to administration of investigational product:\n\n1. Read, understood, and provided written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the trial has been fully explained and must be willing to comply with all trial requirements and procedures\n2. Male or female ≥ 18 years of age\n3. Recurrent\u002FMetastatic Squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx) that is considered incurable by local therapies, who are planning to receive pembrolizumab as first line therapy or for platinum failure. Platinum Failure is defined as recurrence\u002Fprogression between 3-6 months from definitive platinum based chemoradiation therapy.\n4. PD-L1 Combined positive score (CPS) \\>1. PD-L1 can be done by local CLIA certified laboratory.\n5. Has not received anti-PD-1 or Anti-PD-L1 mAb therapy for recurrent\u002Fmetastatic disease. A patient that received anti-PD-1 or Anti-PD-L1 mAb therapy as part of upfront curative intent therapy is eligible as long as it has been at least 1 year since the last dose of anti-PD-1 or anti-PD-L1 mAb therapy.\n6. Is taking opioid therapy to control cancer pain or will initiate opioid therapy to control cancer pain during the screening period.\n7. Has a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale\n8. Measurable disease by RECIST v1.1 that meets the criteria for selection as a target lesion according to RECIST v1.1 (The presence of measurable disease per RECIST v1.1 must be confirmed by local radiology prior to subject entry.)\n9. Adequate organ function as defined by:\n\n   1. Neutrophils ≥ 1,000\u002Fmm3 granulocyte colony-stimulating factor (GCSF) transfusion within 14 days prior to screening is permittable\n   2. Platelets ≥ 75,000\u002Fmm3\n   3. Hemoglobin ≥ 8 g\u002FdL\n   4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN)\n   5. Total bilirubin \\\u003C1.5 × ULN unless known liver metastasis where allowance up to 5 × ULN will be acceptable and for those with known Gilbert's Disease where total bilirubin up to 3.0 × ULN will be acceptable\n   6. Calculated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula) or normal creatinine.\n10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to trial entry and must be willing to use a highly effective method of contraception throughout the trial and trial follow up or for at least 90 days after the last dose of study intervention. NOTE: A woman is considered to be of non-childbearing potential if she meets one of the following criteria: a) post-menopausal with at least 12 months of spontaneous amenorrhea; b) has had a bilateral oophorectomy; or c) has had a hysterectomy.\n11. Males with female partners of childbearing potential must agree to use a highly effective method of contraception throughout the trial and trial follow up or for at least 90 days after the last dose of study intervention. All men with female partners of childbearing potential will be instructed to contact the investigator immediately if their partner becomes pregnant at any time during trial participation. All men must agree not to donate semen throughout the trial and for 90 days after the last dose of study intervention.\n\n    \\-\n\nExclusion Criteria: Individuals will be excluded from the trial for any of the following reasons:\n\n1. Previous severe hypersensitivity reaction to treatment with a monoclonal antibody, hypersensitivity to excipients components of drug product, or has a known sensitivity to any component of the anti-PD-1 antibody (if applicable).\n2. Has received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for nonapproved indications(s) and in the context of a research investigation) ≤ 14 days prior to the first dose of axelopran or within 5 drug half- lives (whichever is shorter) prior to the first dose of study intervention.\n3. Has received any systemic therapy for recurrent\u002Fmetastatic HNSCC.\n4. Patients with any ongoing toxicity related to a prior cancer therapy that is Grade \\>2 and considered by the Sponsor to be a safety risk for the study will be excluded.\n5. Rapid disease progression (within or at 3 months after definitive therapy)\n6. Patients must not be under consideration for salvage surgery. This includes patients whose disease is deemed not resectable, in addition to patients who have declined salvage surgery.\n7. Has received a live attenuated virus vaccine within 30 days of planned study intervention start Note: An individual may be eligible if they have an adequate white cell count such that an immune response can be mounted, at the discretion of the Investigator.\n8. Confirmed HIV or active Hepatitis B or C as determined at baseline screening.\n9. Active infection requiring anti-microbials within 2 weeks of start of trial therapy\n10. Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure (New York Heart Association (NYHA) class III or IV) related to primary cardiac disease, a history of a serious uncontrollable arrhythmia despite treatment, ischemic or severe valvular heart disease, a myocardial infarction within 6 months prior to the trial entry, or QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec at screening\n11. Has not fully recovered from any effects of major surgery, including complications such as infection (Surgeries that required general anesthesia must be completed ≥ 2 weeks before first study intervention administration. Surgery requiring regional\u002Fepidural anesthesia must be completed ≥ 72 hours before first study intervention administration and subjects should be recovered).\n12. Use of immunosuppressive medications within 4 weeks, or systemic corticosteroids within 2 weeks prior to first dose of study intervention (Topical, inhaled, or intranasal corticosteroids \\[with minimal systemic absorption\\] may be continued if the individual is on a stable dose. Non-absorbed intra-articular corticosteroid and replacement steroids \\[prednisone equivalent 10 mg or less\\] will be permitted.)\n13. Underlying medical condition that, in the investigator's opinion, will make the administration of study intervention hazardous or obscure the interpretation of toxicity determination or AEs\n14. Women who are pregnant or breastfeeding\n15. Known alcohol or drug abuse or dependence\n16. Subjects with known or suspected mechanical gastrointestinal obstruction and at increased risk of recurrent obstruction (i.e., Crohn's disease, peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases).\n17. Subjects with moderate or severe renal impairment (eGFR \\\u003C60) or moderate and severe hepatic impairment (Child-Pugh Band C).\n18. Subjects taking moderate to strong CYP3A inhibitors or P-gp inhibitors (see List in Appendix 5)\n\n    \\-","ALL","18 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This Phase 2, open-label, multicenter study will evaluate the safety and preliminary efficacy of axelopran in combination with pembrolizumab in patients with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R\u002FM HNSCC). Axelopran is a peripherally acting mu-opioid receptor antagonist being developed to address opioid-induced immunodeficiency, a condition that may impair anti-tumor immune responses and reduce the effectiveness of immune checkpoint inhibitors.\n\nMany patients with advanced HNSCC require opioid analgesics for cancer-related pain management. Emerging evidence suggests that opioid signaling may suppress immune function and diminish the therapeutic activity of PD-1\u002FPD-L1 inhibitors. By blocking peripheral mu-opioid receptor signaling without affecting central analgesia, axelopran may restore immune competence and enhance response to pembrolizumab.\n\nApproximately 18 patients with PD-L1 positive recurrent or metastatic HNSCC will be enrolled in a two-stage design consisting of an initial futility assessment cohort followed by expansion to the full study population. Participants will receive axelopran in combination with standard pembrolizumab therapy and will be followed for efficacy, safety, and survival outcomes. The estimated study duration is approximately 36 months, including enrollment, treatment, and follow-up.\n\nThe primary objectives are to evaluate objective response rate and assess the safety and tolerability of the combination regimen. Secondary and exploratory objectives include progression-free survival, overall survival, duration of response, and assessment of biomarkers related to immune activation and opioid-induced immunosuppression. This study aims to determine whether targeting opioid-mediated immune suppression can improve clinical outcomes in patients receiving immune checkpoint inhibitor therapy for advanced head and neck cancer.",[28],"Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)",[30,31,32,33,34,35,36,37,38,39,40,41],"axelopran","opioids","immuno-oncology","Head and Neck Squamous Cell Carcinoma (HNSCC)","PD-L1 Positive Tumors","Pembrolizumab","Immunotherapy","Opioid-Induced Immunodeficiency","Peripheral Mu-Opioid Receptor Antagonist","Immune Restoration","glycyx","MORALE-HN","NOT_YET_RECRUITING","2026-06-17",{"date":45,"type":46},"2026-06-23","ACTUAL",{"date":48,"type":21},"2026-06-30",{"date":50,"type":21},"2028-08-31",{"name":52,"class":53},"Glycyx Therapeutics","INDUSTRY",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100641329","phase-2-ccr2-pet-imaging-head-and-neck-squamous-cell-carcinoma-100641329","NCT07659678","CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Adult patient 18 years of age or older\n* Cohort 1: Newly diagnosed locally advanced T3-T4a, N0-3 and M0 squamous cell head and neck cancer scheduled to undergo standard of care surgery with or without neoadjuvant therapy OR Cohort 2: Suspected or biopsy proven recurrent\u002Fmetastatic squamous cell head and neck cancer scheduled to undergo first-line anti-PD1 therapy. HPV status does not need to be known and both HPV+ and HPV- subjects are eligible to enroll\n* Lesion size of at least 1.0 cm in longest dimension by conventional imaging.\n* Able to give informed consent\n* Not currently pregnant or nursing: Female subjects must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post- menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of Cu-DOTA-ECL1i is negative\n\nExclusion Criteria:\n\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years\n* Unable to tolerate approximately 60 min (total time) of PET\u002FCT imaging",{"count":61,"type":21},90,[25],"This is a prospective study to evaluate the sensitivity and specificity of Cu-64 DOTA-ECL1i PET\u002FCT imaging to serve as a novel precision imaging tool for patients with head and neck squamous cell carcinoma (HNSCC).",[65,28,66],"Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC",[68,69,70,71],"Head and neck cancer","P16+ and P16-","PET","CCR2","2026-06-15",{"date":74,"type":46},"2026-06-22",{"date":76,"type":21},"2026-08-31",{"date":78,"type":21},"2032-03-31",{"name":80,"class":81},"Washington University School of Medicine","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":18,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":82},"100641039","phase-1-phase-i-study-of-becotatug-vedotin-for-safety-and-efficacy-in-egfr-positive-pediatric-relapsedrefractory-or-metastatic-solid-tumors-100641039","NCT07584499","Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed\u002FRefractory or Metastatic Solid Tumors","A Phase I Clinical Study to Explore the Safety and Efficacy of Becotatug Vedotin in Pediatric Patients With EGFR-Positive Relapsed\u002FRefractory or Metastatic Solid Tumors","MRG003","Inclusion Criteria:\n\n* All participants must meet all of the following criteria to be eligible for enrollment:\n\nInformed Consent: The patient (and\u002For legal guardian, as age-appropriate) fully understands the study, voluntarily agrees to participate, and signs a written informed consent form (ICF). A separate biomarker consent form is required for EGFR testing prior to screening.\n\nAge: 2 to 18 years old at the time of consent. Life Expectancy: Estimated overall survival of at least 3 months.\n\nHistologically Confirmed Disease: Pathologically confirmed relapsed\u002Frefractory or metastatic EGFR-positive solid tumor, belonging to one of the following subtypes:\n\nHead and neck squamous cell carcinoma, nasopharyngeal carcinoma, or lymphoepithelial carcinoma that progressed during or after at least one line of platinum-based chemotherapy and PD-1\u002FPD-L1 inhibitor therapy Rhabdomyosarcoma Neuroblastoma Medulloblastoma Wilms tumor Atypical teratoid\u002Frhabdoid tumors (AT\u002FRTs) Diffuse intrinsic pontine gliomas (DIPGs) Other EGFR-positive solid tumor subtypes deemed eligible by the investigator Measurable Disease: At least one measurable tumor lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria (longest diameter ≥10 mm; pathological lymph node short axis ≥15 mm).\n\nPerformance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n\nAdequate Bone Marrow Function:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL Platelet count ≥75 × 10⁹\u002FL Hemoglobin ≥80 g\u002FL Exception for patients with bone marrow involvement: ANC ≥1.0 × 10⁹\u002FL, platelets ≥50 × 10⁹\u002FL, hemoglobin ≥75 g\u002FL\n\nAdequate Hepatic and Renal Function:\n\nSerum creatinine ≤1.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN Total bilirubin ≤1.5 × ULN Exception for patients with liver involvement: AST\u002FALT ≤5 × ULN, total bilirubin ≤3 × ULN\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if they meet any of the following criteria:\n\nHypersensitivity: Known hypersensitivity to any component of Becotatug Vedotin (MRG003) or its excipients.\n\nSymptomatic CNS Metastases: Presence of symptomatic central nervous system (CNS) metastases.\n\nPrior Malignancies: History of other primary malignant tumors, except for:\n\nLocally excised basal cell or squamous cell carcinoma of the skin Cervical carcinoma in situ Any prior malignancy that has been in complete remission for ≥3 years without treatment Note: Melanoma (any stage) is explicitly excluded\n\nSignificant Liver Disease: Clinically significant liver disease, including:\n\nPositive hepatitis C virus (HCV) antibody Chronic active hepatitis B (HBV DNA \\>20,000 IU\u002FmL) HIV Infection: Known human immunodeficiency virus (HIV) infection. Severe Ocular Abnormalities: History of severe ophthalmologic conditions, such as severe dry eye syndrome or exposure keratitis.\n\nUncontrolled Systemic Diseases: Severe or uncontrolled medical conditions, including:\n\nInterstitial lung disease or pneumonitis Active autoimmune diseases requiring systemic immunosuppressive therapy\n\nCardiac Disease: Clinically significant cardiac dysfunction or cardiac disease, including:\n\nCongestive heart failure (New York Heart Association Class ≥II) Uncontrolled arrhythmias QTc interval prolongation \\>450 ms (males) or \\>470 ms (females) Recent Antitumor Therapy: Received any systemic antitumor therapy (chemotherapy, biological therapy, immunotherapy, targeted therapy) within 3 weeks prior to the first dose of study drug, and have not recovered to CTCAE v4.03 Grade ≤1 (except alopecia).\n\nRecent Major Surgery: Underwent major surgical procedure within 3 weeks prior to the first dose of study drug.\n\nPlanned Surgery: Planned surgical procedure during the study period, or any surgery deemed necessary by the investigator.\n\nPrior EGFR Therapy Toxicity: History of severe skin toxicity caused by prior EGFR-targeted therapy, or chronic skin disease requiring ongoing oral or intravenous treatment.\n\nOther Significant Risks: Any other concurrent medical condition that, in the investigator's judgment, would increase the risk of toxicity or compromise the patient's ability to complete the study.","2 Years",{"count":93,"type":21},51,[24],"There is a significant unmet medical need for effective therapies for pediatric relapsed\u002Frefractory solid tumors. EGFR is highly and stably expressed in multiple pediatric solid tumor subtypes, and adult Phase I data of Becotatug Vedotin demonstrated a manageable safety profile and promising antitumor activity in EGFR-positive advanced solid tumors.This is a multicenter, non-randomized, single-arm, open-label Phase I clinical trial sponsored by Sun Yat-sen University Cancer Center (SYSUCC). The trial evaluates the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of Becotatug Vedotin-an EGFR-targeted antibody-drug conjugate (ADC)-in pediatric patients with EGFR-positive relapsed\u002Frefractory or metastatic solid tumors.",[28,97,98,99,100,101,102,103,104,105],"Nasopharyngeal Carcinoma","Lymphoepithelial Carcinoma","Rhabdomyosarcoma","Neuroblastoma","Medulloblastoma","Wilms Tumor","Atypical Teratoid\u002FRhabdoid Tumors","Diffuse Intrinsic Pontine Gliomas","Other EGFR-positive Pediatric Solid Tumors Deemed Eligible by the Investigator","RECRUITING","2026-05-07",{"date":109,"type":46},"2026-05-13",{"date":111,"type":21},"2026-05-30",{"date":113,"type":21},"2028-05-30",{"name":115,"class":81},"Sun Yat-sen University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":82},"100625472","phase-2-window-of-opportunity-in-preserving-laryngeal-function-trial-100625472","NCT07423078","Window of Opportunity in Preserving Laryngeal Function Trial","A Phase II Window of Opportunity in Preserving Laryngeal Function (WOLF) Trial","WOLF","Inclusion Criteria:\n\n1. Pathologically confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx\n2. AJCC 8th Edition Stage III - IV disease (T1-T2\u002FN1-N3, T3-T4\u002FN0-N3)\n3. Disease (primary \\& nodal) must be potentially surgically resectable and curable with conventional surgery and CRT\n4. ECOG PS 0 - 2\n5. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry, during the course of the study, and for 1 year after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n7. Must have normal organ and marrow function as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count ≥ 1,500\u002FmcL\n   * Platelet count ≥ 100,000\u002FmcL\n   * Total bilirubin ≤ 1.5 X the institutional upper limit of normal (ULN)\n   * AST (SGOT) ≤ 2.5 X institutional upper limit of normal (ULN)\n   * ALT (SGPT) ≤ 2.5 X institutional ULN\n   * Creatinine clearance ≥ 40 mL\u002Fmin\u002F1.73 m2 for patients with a creatinine level above institutional normal\n8. Must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Prior treatment for head and neck cancer\n2. Unresectable laryngeal or hypopharyngeal squamous cell carcinoma\n3. Distant metastatic disease\n4. Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism or Sjogren's syndrome will not be excluded from the study.\n5. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n6. Known allergy or hypersensitivity to carboplatin or cisplatin, toripalimab, or paclitaxel.\n7. Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes for the patient.\n8. Peripheral sensory neuropathy \\> grade 2 by CTCAE v5.0\n9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n10. Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\]) or HIV infection (see note).\n\n    1. Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.\n    2. Note: Participants with a history of HIV infection are considered eligible if CD4+ T cell counts are ≥350 cells\u002FµL and the patient has had no opportunistic infections in the last 12 months.",{"count":125,"type":21},87,[25],"This trial will study the safety and tolerability and disease survival rates in adult patients with recurrent\u002Fmetastatic (R\u002FM) HNSCC when treated with carboplatin or cisplatin, paclitaxel, and toripalimab.",[28,129,130],"Locally Advanced Laryngeal Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma",[132,133,134],"immunotherapy","laryngectomy","neoadjuvant","2026-04-06",{"date":137,"type":46},"2026-04-13",{"date":135,"type":46},{"date":140,"type":21},"2031-04-30",{"name":142,"class":81},"Matthew Spector"]