[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-of-the-head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-of-the-head-and-neck":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100398583","phase-1-phase-ib-trial-of-multivalent-autophagosome-vaccine-with-or-without-gitr-agonist-with-anti-pd-1-immunotherapy-in-hnscc-100398583",false,"NCT04470024","Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC","A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix C)\n* Age 18 years or above.\n* Laboratory values:\n* WBC ≥2000\u002FuL\n* Hgb \\>8.0 g\u002Fdl (patients may be transfused to reach this level)\n* Platelets \\>75,000 cells\u002Fmm3\n* Serum creatinine clearance ≥ 50 mL\u002Fmin measured or calculated by Cockcroft-Gault (C-G) equation\n* Negative bHCG (urine\u002Fserum) Women of childbearing potential only\n* AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of laboratory normal (ULN) OR ≤ 5 × ULN for participants with liver metastases\n* Alkaline phosphatase ≤2.5 × ULN OR ≤ 5 × ULN for participants with liver metastases\n* Total bilirubin ≤1.5 × ULN. If total bilirubin is \\>1.5, conjugated bilirubin must be ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then conjugated bilirubin must be \\\u003C 40% of total bilirubin.\n* Patients positive for hepatitis B core antibody (anti-HBc, total), are eligible only if HBV DNA is non-detectable by qPCR.\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if HCV RNA is non-detectable by qPCR.\n* Patients positive for HIV 1\u002F2 antibodies, are eligible if ARV treatment compliant with documented stable CD4 \\> 300 for at least 6 months and undetectable viral load\n* Ability to give informed consent and comply with the protocol.\n* Anticipated lifespan greater than 12 weeks.\n* Women of childbearing potential must have negative serum\u002Furine pregnancy test \\\u003C5 days prior to start of study.\n* Males and women of childbearing potential, must agree to take appropriate precautions to avoid pregnancy during treatment and through 180 days after last dose of study treatment (see Appendix A).\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n* Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.\n* Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy), excluding target lesions, Palliative radiation therapy cannot be administered less than 1 week prior to the first dose of study treatment.\n* Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.\n* Radiation therapy in the thoracic region that is \\> 30 Gy within 6 months of the first dose of study treatment. Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids for this purpose, and not have had radiation pneumonitis.\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n* History of organ transplant, including allogeneic stem cell transplantation.\n* Uncontrolled intercurrent illness as deemed by the investigator, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia, interstitial lung disease or history of, serious chronic gastrointestinal conditions associated with diarrhea, active noninfectious pneumonitis, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* History of another primary malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease ≥1.5 years before the first dose of investigational product and of low potential risk for recurrence\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* History of leptomeningeal carcinomatosis\n* Has untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients whose brain metastases have been treated may participate provided they show radiographic stability (imaging at least four weeks apart showing no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤10mg\u002Fday of prednisone or its equivalent and anti-seizure medications for at least 14 days prior to the start of treatment. Patients on a stable dose of seizure medicines for epilepsy unrelated to cancer are eligible for the trial.\n* History of active primary immunodeficiency.\n* Active tuberculosis infection (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).:\n\n  * 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  * Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.\n  * Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n  * Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedication are permitted.\n* Receipt of live attenuated vaccine within 28 days prior to the first dose of study treatment. Note: patients should not receive live vaccine during study treatment and up to 30 days after the last dose of study treatment.\n* Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.\n* Any unresolved NCI CTCAE Grade ≥2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia, and the laboratory values defined in the inclusion criteria.\n* Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Principal Investigator or one of the Co-Principal Investigators.\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by study treatment may be included only after consultation with the Principal Investigator or one of the Co-Principal Investigators.\n* Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines) OR\n* any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).\n* Receipt of systemic antibiotics ≤ 7 days prior to the first dose of study drug.","ALL","18 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.",[26],"Cancer of the Head and Neck","RECRUITING","2026-04-07",{"date":30,"type":31},"2026-04-13","ACTUAL",{"date":33,"type":31},"2021-08-05",{"date":35,"type":20},"2028-12-31",{"name":37,"class":38},"Providence Health & Services","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":39},"100396650","phase-2-testing-less-intensive-radiation-with-chemotherapy-to-treat-low-risk-patients-with-hpv-positive-oropharyngeal-cancer-100396650","NCT04444869","Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer","Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx \"ENID\"","ENID","Inclusion Criteria:\n\n* Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.\n* Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).\n* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.\n* Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.\n* Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:\n\n  * General history and physical examination within 30 days prior to registration;\n  * Fiberoptic exam with laryngopharyngoscopy (mirror and\u002For fiberoptic and\u002For direct procedure) within 60 days prior to registration;\n  * One of the following combinations of imaging is required within 45 days prior to registration:\n\n    1. A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast);\n    2. or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast);\n    3. or a CT scan of neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast);\n    4. or an MRI of the neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast).\n\nNote: A CT scan of neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as both staging and planning tools.\n\n* Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial.\n\nNumber of pack-years = \\[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\\] \u002F 20 Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined.\n\n* Zubrod Performance Status of 0-1 within 30 days prior to registration;\n* Adequate hematologic function within 14 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3;\n  * Platelets ≥ 100,000 cells\u002Fmm3;\n  * Hemoglobin ≥ 8.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable.\n* Adequate renal function within 14 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin\n* Adequate hepatic function within 14 days prior to registration defined as follows:\n\n  * Bilirubin \\\u003C 2 mg\u002Fdl;\n  * AST or ALT \\\u003C 3 x the upper limit of normal.\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n\nExclusion Criteria:\n\n* Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;\n* Carcinoma of the neck of unknown primary site origin (even if p16 positive);\n* T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.\n* Radiographically matted nodes, that span 6 cm or more; N3 disease\n* Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;\n* Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;\n* Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.\n* Simultaneous primary cancers or separate bilateral primary tumor sites;\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n  * Transmural myocardial infarction within the last 6 months;\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.11 of the protocol.",{"count":49,"type":20},28,[51],"PHASE2","This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.",[26,54,55,56],"Oropharynx Cancer","HPV Positive Oropharyngeal Squamous Cell Carcinoma","Throat Carcinoma","2024-05-16",{"date":59,"type":31},"2024-05-17",{"date":61,"type":31},"2020-09-28",{"date":63,"type":20},"2026-06",{"name":65,"class":38},"University of Missouri-Columbia"]