[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-vaccine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-vaccine":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100533265","phase-2-phase-ii-trial-of-neoadjuvant-chemotherapy-nac-alone-or-in-combination-with-immunotherapy-vaccine-prgn-2009-in-subjects-with-newly-diagnosed-hpv-associated-oropharyngeal-head-and-neck-cancer-100533265",false,"NCT06223568","Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous cell carcinoma. Note: Pathological report of cancer diagnosis may be from the primary tumor or from a metastatic cervical lymph node.\n* History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible.\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 2.\n* Individuals who smoke currently must smoke \\\u003C10 pack years. Note: Former smokers with any pack-year history are eligible if quit smoking \\>10 years before study treatment initiation. Former smokers who quit \\\u003C10 years before study treatment initiation must have smoked \\\u003C10 pack years.\n* Planned for cancer removal surgery per standard of care (SOC) and individual had agreed for the cancer removal surgery.\n\n  * Individuals must have adequate organ and marrow function as defined below:\n  * Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n  * Hemoglobin (Hgb) \\>= 9.0 g\u002FdL\n  * Platelet count \\>= 100 x 10\\^9\u002FL\n  * Creatinine \\\u003C= 1.2 x upper limit of normal (ULN) OR calculated creatinine clearance \\>=55 mL\u002Fmin\u002F1.73m\\^2 by Cockcroft-Gault formula\n* Total bilirubin \\\u003C= 1 x ULN, or \\\u003C= 3 x ULN in patients with known or suspected Gilbert's Syndrome\n* Alanine aminotransferase (ALT) \\\u003C= 1.5 x ULN\n* Aspartate aminotransferase (AST) \\\u003C= 1.5 x ULN\n* Individuals serologically positive for human immunodeficiency virus (HIV) must:\n\n  * be on effective anti-retroviral therapy for at least 4 weeks; and\n  * have undetectable viral load; and\n  * have the CD4 count \\>=200 cells\u002FmicroL; and\n  * have no reported opportunistic infections or Castleman s disease within 12 months prior to study treatment initiation\n* Individuals serologically positive for Hepatitis C virus (HCV) or Hepatitis B virus (HCB) must have an undetectable viral load.\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for 14 months after the last dose of cisplatin\u002Fdocetaxel. Note: IOCBP is defined as any woman who has experienced menarche and has not had a hysterectomy or bilateral oophorectomy or is not postmenopausal (amenorrheic 12 months or more following cessation of exogenous hormonal treatments; if \\\u003C50 years old and need follicle stimulating hormone \\[FSH\\] in the post-menopausal range).\n\nMen must agree to use a highly effective method of contraception (surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 11 months after the last dose of the study drug(s). We also will recommend men on treatment with PRGN-2009 with female partners of childbearing potential ask female partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization) during PRGN-2009 treatment and 2 months after that.\n\n* Breastfeeding individuals must be willing to discontinue breastfeeding from study treatment initiation through 2 months after the last dose of the study drug(s).\n* Individuals must have a tumor site that is amenable to biopsy and be willing to undergo pre- treatment biopsy for research purposes.\n* Individuals must be willing to undergo pre-treatment PET\u002FCT imaging study.\n* The ability of an individual to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Peripheral motor or sensory neuropathy \\> Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v.5 at screening.\n* Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration. Note: Participants may continue adjuvant hormonal therapy in the setting of a definitively treated cancer (e.g., breast).\n* Prior therapy with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A) https:\u002F\u002Fwww.fda.gov\u002FDrugs\u002FDevelopmentApprovalProcess\u002FDevelopmentResources\u002FDrugInteractionsLabeling\u002Fucm093664.htm#table2-2,table3-3,table5-2 within 2 weeks prior to the first study drug administration.\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.\n* Systemic (intravenous or oral) glucocorticoid (except for physiologic doses of corticosteroids, i.e., \\\u003C= the equivalent of prednisone 10 mg\u002Fday) or other immunosuppressors such as azathioprine or cyclosporin A within 1 week prior to study treatment initiation. Note: Glucocorticoids as premedication for contrast-enhanced studies are allowed.\n* Second malignancy active within the previous 2 years except for indolent or locally curable malignancy that is currently considered cured and\u002For does not require an additional standard of care treatment, such as, but not limited to, cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer or differentiated thyroid cancer.\n* Prior allogenic tissue\u002Fsolid organ transplant.\n* History of heart failure.\n* Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.\n* Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history and physical exam or situations that are not stable (e.g., recent hospitalization, Emergency Room visit or undergoing medication changes) that would potentially increase risk for the participant.","ALL","18 Years","120 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nThroat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation.\n\nObjective:\n\nTo test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers.\n\nEligibility:\n\nPeople aged 18 years and older with newly diagnosed throat cancer associated with HPV.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken.\n\nAll participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles.\n\nHalf of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle.\n\nParticipants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery.\n\n...",[26,27,28,29,30],"Squamous Cell Carcinoma of the Head and Neck","Oropharynx","Human Papillomavirus Viruses","Drug Therapy","Cancer Vaccine",[32,33,34,35],"Neoadjuvant Chemotherapy","Oropharynx Cancer","Human Papillomavirus","Therapeutic Vaccine","RECRUITING","2026-06-09",{"date":39,"type":40},"2026-06-10","ACTUAL",{"date":42,"type":40},"2024-06-10",{"date":44,"type":20},"2028-01-10",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100583614","phase-1-a-polyphenol-whole-tumor-cell-vaccine-in-patients-with-advanced-malignant-solid-tumors-100583614","NCT06878612","a Polyphenol Whole Tumor Cell Vaccine in Patients With Advanced Malignant Solid Tumors","A Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of a Polyphenol Whole Tumor Cell Vaccine in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Male or female patients aged 18 to 65 years (including borderline values) at screening.\n2. Advanced metastatic malignant solid tumors (skin or limb melanoma\u002Fhead and neck tumors\u002Fsoft tissue tumors, etc.) confirmed histologically or cytologically, with previous failure of second-line or higher treatment (refer to the China Clinical Oncology (CSCO) Melanoma Guidelines 2024, CSCO Head and Neck Tumor Guidelines 2024, and CSCO Bone and Soft Tissue Tumor Guidelines.\n\n   Note: ① Advanced metastatic melanoma: first-line standard treatment includes dacarbazine\u002Ftimozolomide ± platinum ± endo, and dabrafenib + trametinib is recommended if the BRAF V600 mutation is carried. Second-line treatment may be considered with a different drug therapy than first-line treatment, and if PD-1 monoclonal antibody is not used in the first line, pabolizumab or treprotilizumab is recommended in the second line. If tumor reduction is urgently needed, targeted drugs or chemotherapy combination regimens (paclitaxel\u002Falbumin paclitaxel ± platinum ± antivascular drugs) are preferred in the second line. If NRAS mutation is carried, tulolametinib (HL085) is recommended.\n\n   (ii) Advanced metastatic head and neck tumors: first-line standard treatment includes pembrolizumab + cisplatin\u002Fcarboplatin + 5-Fu, pembrolizumab (CPS ≥ 1), cisplatin\u002Fcarboplatin + 5-Fu + cetuximab, cisplatin + docetaxel + cetuximab, and cisplatin\u002Fcarboplatin + paclitaxel ± cetuximab. Second-line or salvage therapy is recommended, such as nabulizumab.\n\n   (iii) Advanced metastatic soft tissue sarcoma: first-line standard treatment includes doxorubicin ± isocyclophosphamide chemotherapy, and second-line treatment is based on the specific type of chemotherapy or amilorotinib targeted therapy.\n3. Presence of at least 1 measurable or evaluable lesion according to RECIST v1.1 criteria.\n4. Eastern Cooperative Oncology Group (ECOG) physical status score: 0 to 2.\n5. Expected survival ≥ 3 months.\n6. Good function of major organs, and the following requirements are met by the examination indexes within 7 days prior to receiving treatment:\n\n   ① Hemoglobin ≥80 g\u002FL; neutrophil count \\>1.5×109\u002FL; platelet count ≥80×109\u002FL;\n\n   ② Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 × ULN; if there are liver metastases, ALT or AST ≤ 5 × ULN;\n\n   ③ Creatinine (SCr) ≤ 1.5 × ULN or creatinine clearance (CRCI) ≥ 60 mL\u002Fmin (Cockcroft-Gault formula) (see 16.6 Appendix VI);\n\n   ④ Prothrombin time (PT), International Normalized Ratio (INR) ≤ 1.5 x ULN (unless warfarin anticoagulation is being used).\n\n   ⑤ Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.\n7. Able to understand and voluntarily sign a written informed consent before the trial.\n\nExclusion Criteria:\n\n1. Patients with a prior history of other tumors, except for cured and non-recurrent basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal carcinoma, and other histories of malignancies deemed by the investigator to be eligible for enrollment.\n2. Patients with known concomitant cardiac clinical conditions or diseases that are not well controlled, e.g., New York Heart Association (NYHA) class II or higher heart failure (see 16.5 Appendix V), unstable angina, myocardial infarction within 6 months, supraventricular or ventricular arrhythmias that are clinically significant and require treatment or intervention.\n3. Patients with previous and current objective evidence of asthma, history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severely impaired lung function.\n4. Have any uncontrollable clinical disease (e.g., respiratory, circulatory, digestive, neurologic, hematologic, genitourinary, endocrine system disorders) or psychiatric disease (e.g., depression, schizophrenia) or other significant illnesses assessed by the investigator as preventing the provision of informed consent, interfering with the interpretation of the trial results, potentially posing a risk to subjects by participating in this trial, or otherwise otherwise interfere with achieving the purpose of the study.\n5. Have any active autoimmune disease or a history of autoimmune disease including, but not limited to, immune-related neurological disorders, multiple sclerosis, autoimmune (demyelinating) neuropathies, Guillain-Barre Syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis-relaxation (TEN) or Stevens-Johnson syndrome (except for type I diabetes on stable doses of insulin).\n6. Allergy to the test drug (including any excipients). Prior history of severe allergy to any drug, food, or vaccination, such as anaphylaxis, anaphylactic laryngeal edema, anaphylactic dyspnea, anaphylactic purpura, thrombocytopenic purpura, and localized anaphylactic necrotic reaction (Arthus reaction).\n7. the existence of intradermal injection contraindications: ① injection site inflammation, trauma ulceration. ② severe bleeding, coagulation tendency, platelets or coagulation factors significantly reduced. ③ Any abnormalities or permanent body art (e.g., tattoos) at the vaccination site that, in the opinion of the investigator, would prevent observation of local reactions at the vaccination site.\n8. Participation in other drug or device clinical trials within 3 months prior to screening.\n9. Major surgery (minor surgery such as catheterization, protocol-required biopsy procedures, etc. is not an exclusion criterion) within 4 weeks prior to the first dose of vaccination or less than 14 days of elimination of the effects of surgery or trauma prior to enrollment, radiotherapy, targeted, immune checkpoint inhibitors, interferon, live\u002Flive attenuated vaccines, and other treatments.\n10. Patients who have not recovered to NCI CTCAE ≤ grade 1 for antitumor therapy-related adverse reactions (except alopecia) after previous antitumor therapy.\n11. Subjects on systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive agents within 14 days prior to the first dose of vaccination. Inhaled or topical steroids and adrenal hormone replacement at doses ≤ 10 mg\u002Fday prednisone efficacy dose are allowed in the absence of active autoimmune disease.\n12. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and syphilis infections, or positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCVAb), HIV antibody, and syphilitic spirochete (TP) antibody test at screening: HBsAg (+) or HBcAb (+), and HBV DNA copy number ≥ 2000 IU\u002FmL (or the lower limit of positive test values at the host research center); HCVAb positive and HCV RNA ≥ ULN at the host research center.\n13. Patient has a history of active tuberculosis (TB) (patients suspected of having active TB need to be examined on chest X-ray, sputum, and excluded by clinical signs and symptoms) or active TB; or severe acute or chronic infection requiring systemic therapy.\n14. History of substance abuse or known medical, psychological, or social conditions such as alcohol or drug abuse.\n15. Pregnant or breastfeeding women with a screening period up to 12 months after the full course of drug injection, a planned pregnancy in a female subject or a planned pregnancy in the partner of a male subject.\n16. Any other factors that, in the opinion of the investigator, make it inappropriate for the subject to enter this trial.","65 Years",{"count":58,"type":20},9,[60],"PHASE1","This project intends to carry out phase I clinical studies on the basis of the previous work, initially exploring the possible effective dose, evaluating its safety and tolerability, with a view to achieving long-term control of the disease, which is expected to provide more options for the treatment of patients with advanced malignant solid tumors. The development of this project will provide new ideas, strategies and theoretical basis for the research and development of whole tumor cell vaccines; at the same time, it is expected to obtain original new drugs with independent intellectual property rights.",[63,30,64],"Polyphenols","Advanced Solid Tumor",[66,67,68],"polyphenols","whole tumor cell vaccine","advanced solid tumor","2025-06-01",{"date":71,"type":40},"2025-06-05",{"date":73,"type":40},"2025-04-21",{"date":75,"type":20},"2026-12-31",{"name":77,"class":78},"Xingchen Peng","OTHER"]