[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100628371","phase-1-safety-and-feasibility-of-nivolumab-irdye800cw-in-patients-with-head-and-neck-squamous-cell-carcinoma-hnscc-100628371",false,"NCT07460765","Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.\n* Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).\n* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)\u002FZubrod level 0-2.\n\nExclusion Criteria:\n\n* Patients not planning for SOC surgical resection\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n     1. Rash must cover \\\u003C 10% of body surface area\n     2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n     3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n* History of hepatitis C that has not been treated with curative intent.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy.\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n* Prior allogeneic stem cell or solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n  1. Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n  2. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  3. Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if \\>30 days from first infusion.\n  4. Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n  5. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n* Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","The goal of this Phase 1 clinical trial is to evaluate the safety and feasibility of nivolumab-IRDye800CW (nivo800) as a molecular imaging agent in adults with biopsy-confirmed or presumed head and neck squamous cell carcinoma (HNSCC) who are scheduled to undergo standard-of-care surgical resection.\n\nThe main questions it aims to answer are:\n\n* Is nivolumab-IRDye800CW (nivo800) safe when administered before surgery, as measured by the occurrence of clinically significant Grade ≥2 adverse events that are possibly, probably, or definitely related to the study drug?\n* What is the extent of pathological response at each dose level, including residual viable tumor, fibrosis, necrosis, and tumor-infiltrating lymphocyte characteristics?\n\nParticipants will:\n\n* Receive two intravenous infusions during the preoperative period, approximately 2-3 weeks before surgery and again 1-2 days before surgery.\n* Undergo standard-of-care surgical resection with collection of tumor and lymph node specimens for pathological and imaging studies.",[25,26,27,28,29,30,31,32,33,34,35],"Hnscc","Head and Neck","Squamous Cell Cancer","Squamous Carcinoma","Squamous Cell Cancer of Head and Neck (SCCHN)","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma Mouth","Squamous Carcinoma Poorly Differentiated","Squamous Cell Cancer of the Head and Neck","Squamous Cell Carcinoma (SCC) of the Oral Cavity","Squamous Cell Carcinoma (SCC)",[37,38,39,40,41,42,43,44,45],"nivo800","neoadjuvant","surgery","head and neck cancer","head and neck","surgical resection","oral cancer","SCC","HNSCC","RECRUITING","2026-07-03",{"date":49,"type":50},"2026-07-07","ACTUAL",{"date":52,"type":19},"2026-07",{"date":54,"type":19},"2031-04",{"name":56,"class":57},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":20,"phases":69,"briefSummary":70,"conditions":71,"keywords":77,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":58},"100546705","phase-1-r-5780-01-in-combination-with-pd-1-checkpoint-inhibitors-checkpoint-protein-on-immune-cells-called-t-cells-in-patients-with-solid-tumors-100546705","NCT06398418","R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors","A Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors","Inclusion Criteria:\n\n* At least 18 years of age to 80\n* Ability to provide written informed consent\n* Unresectable stage III or stage IV melanoma, basal cell carcinoma, or squamous cell carcinoma as per the American Joint Committee on Cancer 2017 Guidelines (8th Edition) regardless of BRAF mutation status and other solid tumors.\n* Refractory to anti-PD (checkpoint Protein on Immune Cells called T cells)-1\u002FL1 therapy per RECIST v1.1 defined as subject who has disease progression after receiving at least two complete cycles of ICI (immune checkpoint inhibitors) therapy or disease progression 6 months from initiation of ICI (immune checkpoint inhibitors) therapy while still on active therapy.\n* Life expectancy of greater than 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Subjects must have evaluable disease by CT (computer tomography) or MRI (magnet resonance imaging) per RECIST 1.1 criteria or clinically apparent disease that the investigator can follow for response.\n\nExclusion Criteria:\n\n* Any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in the opinion of the Investigator) would preclude protocol adherence or would make the safety of the study drug difficult to assess\n* Treatment with systemic broad-spectrum antibiotics.\n* No active viral infections.\n* Coexisting severe chronic diseases other than cancer (autoimmunity, inflammatory diseases)\n* Secondary gastrointestinal motility disorders\n* History of solid organ transplant or bone marrow transplant\n* Prior CAR-T (chimeric antigen receptor) or allogeneic cellular therapy\n* Ongoing systemic immunosuppressive therapy, with the exclusion of prednisone (10 mg\u002Fday)\n* Concurrent therapy with any other investigational agent, vaccine, or device\n* Pregnant or breastfeeding or planning to conceive or father a child during the trial period\n* Subjects with untreated brain metastasis. Treated brain metastasis are permitted if stable\n* More than 4 prior systemic therapies\n* Other cancer medications during treatment period are not permitted\n* Enrollment in other clinical trials.","80 Years",{"count":68,"type":19},33,[22],"The goal of this study is determine the safety and tolerability of orally taken probiotic (R-5780) in patients currently on a PD-1 Pathway Checkpoint Inhibitor (checkpoint protein on immune cells called T cells) with Solid Tumors.",[72,73,74,75,27,76],"Solid Tumor, Adult","Solid Tumor","Melanoma","Basal Cell Cancer","Adenoma",[78],"Solid Tumors","2025-08-27",{"date":81,"type":50},"2025-09-04",{"date":83,"type":50},"2025-08-01",{"date":85,"type":19},"2027-12-31",{"name":87,"class":88},"Rise Therapeutics LLC","INDUSTRY"]