[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Glenn J. Hanna\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,73,96,122],{"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":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100498795","phase-1-cb-103-with-either-lenvatinib-or-abemaciclib-in-patients-with-notch-acc-100498795",false,"NCT05774899","CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC","A Phase 1\u002F2 Study of CB-103 (Oral Pan-NOTCH Inhibitor) With Abemaciclib or Lenvatinib in Combination in Patients With NOTCH Activated Adenoid Cystic Carcinoma (CALCulus)","Participants must meet the following eligibility criteria at the time of screening to be eligible to participate in the study:\n\nEligibility Criteria\n\n1. Participants must have histologically confirmed adenoid cystic carcinoma (ACC) with evidence of recurrent, metastatic or advanced, incurable disease arising from any primary site\n2. Activating mutation in the NOTCH signaling pathway\n3. In Cohort 1 only, prior multitargeted VEGFR TKI or systemic therapy is permitted.\n4. In Cohort 2 only, no prior multitargeted VEGFR TKI therapy is permitted, but prior systemic chemotherapy as part of definitive or curative intent management is permitted.\n\n   a. Any participant must obtain prior approval from insurance to reimburse for oral Lenvatinib, or off-label drug assistance to secure Lenvatinib for the duration of the study or agree to self-pay for oral Lenvatinib or obtain institutional commitment from the study site to provide Lenvatinib.\n5. Age 18 years or older\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n7. Patients able and willing to swallow oral capsules or tablet medications.\n8. At least one measurable lesion (RECIST v1.1)\n9. Participant must have organ and marrow function as defined below within 14 days prior to study registration (ULN=upper limit of normal per institution):\n\n   Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL Hemoglobin (Hgb) ≥9 g\u002FdL (patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion).\n\n   Platelet count ≥100 x 109\u002FL (without transfusion within the last 5 days) Serum creatinine ≤1.5x ULN or serum creatinine clearance (CrCl) ≥50 mL\u002Fmin (estimated by Cockcroft-Gault formula) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3x ULN Total serum bilirubin ≤1.5x ULN (patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted).\n10. Baseline proteinuria with a urinalysis or urine dipstick value of 2+ requires a spot urine protein\u002Fcreatinine ratio of \\\u003C0.3 (or 24-hour urine collection protein value \\\u003C300 mg\u002Fg) in Cohort 2 only\n11. Participants with treated brain or CNS metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no convincing evidence of progression and patients are neurologically stable with no new neurological deficits.\n12. Female subjects of childbearing potential should have a negative serum pregnancy test within 7 days before start of study treatment.\n13. Female and male subjects of childbearing potential must agree to use an adequate method of contraception to avoid pregnancy (with at least 99% certainty) from screening through 90-days or 3-months post-treatment completion (see Appendix B).\n14. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n15. Patients who received chemotherapy must have recovered (CTCAE grade ≤1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy. A washout period of at least 21 days is required between last chemotherapy dose and start of therapy (provided the patient did not receive radiotherapy).\n\nExclusion Criteria\n\n1. Participant has untreated or clinically symptomatic CNS metastases and\u002For carcinomatous meningitis\n2. The patient has had major surgery within 14 days prior to study registration.\n3. The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea).\n4. Impairment of GI function or presence of GI disease that may significantly alter the absorption of the study agents (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n5. The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n6. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n7. Pregnant or lactating women. Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.\n8. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and start of therapy. Patients on anticoagulants that require INR monitoring (such as warfarin). The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study.\n9. Corrected QTcF \\>450 msec for males and \\>470 msec for females in screening","ALL","18 Years",{"count":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this study is to treat patients with NOTCH active advanced adenoid cystic carcinoma (ACC) tumors with a combination or two different oral medications to slow tumor growth and improve survival outcomes.\n\nThe names of the study drugs involved in this study are:\n\n* CB-103 (an oral NOTCH pathway inhibitor)\n* Abemaciclib (CDK4\u002F6 inhibitor)\n* Lenvatinib (a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI))",[27,28,29],"Adenoid Cystic Carcinoma","Metastatic Adenoid Cystic Carcinoma","Recurrent Adenoid Cystic Carcinoma",[27,28,29,31],"ACC","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2023-06-01",{"date":40,"type":20},"2028-06-01",{"name":42,"class":43},"Glenn J. Hanna","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100534468","phase-2-pd-l1-t-hank-nai-il-15sa-and-cetuximab-for-recurrent-metastatic-hnscc-100534468","NCT06239220","PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC","A Phase 2 Trial of PD-L1 t-haNK, NAI IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)","Inclusion Criteria:\n\n* Participants must have an existing histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) with evidence of recurrent, metastatic (R\u002FM) or locoregionally advanced, incurable or unresectable disease from any mucosal subsite including oral cavity, oropharynx, larynx, hypopharynx, nasal cavity, and the paranasal sinuses.\n* Participants must have at least one RECIST v1.1 measurable lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥ 1 cm with CT scans or MR imaging.\n* Must have had at least 1, but no more than 2, prior lines of prior systemic therapy for R\u002FM HNSCC; one of these lines should have included anti-PD-1\u002FL1 therapy.\n\n  * a.Platinum-based therapy as part of definitive\u002Fadjuvant or curative-intent treatment can count as 1 prior line of therapy if the subject progressed within 6 months of receiving therapy.\n  * b. At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (2 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE v5 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or peripheral neuropathy).\n* Be ≥18 years of age on the day of signing informed consent.\n* Must provide prior documentation on tumor PD-L1 expression status and HPV status (for oropharyngeal cancer cases), if available from the medical record.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale (see Appendix A).\n* Participants must have adequate organ and marrow function as defined below (within 14 days prior to study registration):\n\n  * a. ANC ≥1,000\u002FmcL\n  * b. Hemoglobin ≥9 g\u002FdL\n  * c. Platelets ≥100,000\u002FmcL\n  * d. Total bilirubin ≤ upper limit of normal (ULN)\n  * e. AST(SGOT)\u002FALT(SGPT) ≤2.5x institutional ULN (or ≤1.5x institutional ULN if concomitant with alkaline phosphatase \\>2.5x institutional ULN) or ≤5x ULN for those with liver metastases\n  * g. Serum creatinine ≤1.5x ULN or creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above 1.5x ULN\n* Baseline tumor measurements must be documented from imaging within 28 days prior to study registration.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects should not become pregnant or nurse a baby during the study and through 120 days after the last dose of study drugs. Male subjects should use a condom as a contraceptive during the study and through 120 days after the last dose of study drugs.\n\nSperm donation is discouraged for up to 6 months after the last dose of study drug.\n\n-Be willing and able to provide written informed consent for the trial.\n\nExclusion Criteria\n\n* Have been previously treated with 3 or more lines of systemic therapy for R\u002FM HNSCC.\n* Have received radiation therapy (RT) within 10 days of starting protocol therapy.\n* Solid organ transplant (allograft) recipients.\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging and off systemic steroids for at least 3 weeks prior to study registration) and have no evidence of new or enlarging brain metastases.\n* A history of significant autoimmune disease as judged by the treating investigator and on active therapy including prednisone ≥10 mg daily dose equivalent of corticosteroids.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection; evidence of symptomatic congestive heart failure, unstable angina pectoris, stroke, or ventricular arrhythmia within 6 months of enrollment.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions might include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Any known positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative). Patients with HIV are eligible if their plasma HIV viral load is undetectable at baseline on antiretroviral therapy.\n* Subjects who are pregnant, or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Breastfeeding should be discontinued if the mother is treated on this protocol. Women who could potentially become pregnant while undergoing treatment on this protocol must be willing to use 2 methods of contraception.",{"count":53,"type":20},25,[24],"The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer.\n\nThe names of the therapies involved in this study are:\n\n* PD-L1 t-haNK cell therapy (a NK cell therapy infusion)\n* NAI (a type of recombinant human superagonist)\n* Cetuximab (a type of antibody)",[57,58,59,60,61,62],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Recurrent Head and Neck Cancer","Metastatic Head-and-neck Squamous-cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma",[57,58,59,60,61,62],"2026-06-10",{"date":66,"type":36},"2026-06-11",{"date":68,"type":36},"2024-02-16",{"date":70,"type":20},"2027-01-31",{"name":42,"class":43},2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":72},"100563972","phase-2-phase-ii-study-of-rp2-as-immunoprevention-in-high-risk-oral-precancerous-disease-100563972","NCT06623110","Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease","A Phase 2 Study of Intralesional RP2 as Immunoprevention for High-Risk Oral Precancerous Disease (INTERCEPT)","INTERCEPT","Inclusion Criteria:\n\n* Patients with a diagnosis of high-risk OPD defined by any of the following:\n\n  * Proliferative leukoplakia (PL)\n  * Localized leukoplakia showing at least moderate dysplasia not treated with surgery\n  * Erythroplakia (regardless of dysplasia)\n  * High-risk LOH profile: 9p21 or CDKN2A or MTAP loss; regardless of personal oral cancer history\n  * Any degree of dysplasia with a known TP53 mutation\n  * A history of treated stage 1 or 2 (AJCC 2017 8th edition) HNSCC with at least moderate dysplasia at the resection margins or known 9p21 loss or a known TP53 mutation\n* No evidence of head and neck cancer recurrence within the last 3 months (if applicable).\n* Willing to provide blood and tissue for diagnostic biopsies.\n* At least one target injectable measurable lesion ≥1 cm in longest diameter that can be followed.\n* Any smoking history is permitted. While discouraged, patients are permitted to continue tobacco use while on the study.\n* Age 18 years or older at the time of consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n* Participant must have normal marrow function and coagulation profile as defined within 21 days prior to study registration:\n\n  * absolute neutrophil count ≥1,000\u002FmcL\n  * hemoglobin ≥9 g\u002FdL\n  * platelets ≥75,000\u002FmcL, and (d) PT\u002FINR \\\u003C2.5, and (e) aPTT \\\u003C1.5x ULN.\n* Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception. WOCBP and men should plan to use an adequate method to avoid pregnancy for 90 days after the last dose of RP2. WOCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Serum or urine BhCG testing is required within 24 hours of initial RP2 dosing.\n\nExclusion Criteria:\n\n* Prior treatment with an oncolytic virus therapy.\n* Systemic infection requiring intravenous (IV) antibiotics.\n* Requires chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (e.g. acyclovir or valacyclovir).\n* Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis). Patients with sporadic cold sores may be enrolled provided they are asymptomatic at the time of starting RP2.\n* Known acute or chronic hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or acute or chronic hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected). Note: Patients who have been effectively treated are eligible for enrollment. Patients must be negative for HBsAg and HCV RNA.\n* Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.\n* A history of a prior stage III (T1-2N1, T3N0) or IV (T1-3N2, T4N0) invasive head \\& neck squamous cell carcinoma treated with surgery and\u002For radiation with or without chemotherapy.\n* Patients cannot be on long-term (\\>4 weeks) corticosteroids at doses exceeding prednisone 20 mg daily (or its equivalent) at the time of enrollment.\n* A personal history of hematopoietic stem cell (bone marrow) or solid organ transplant.\n* A personal history of other active malignancies, with exceptions including (but not limited to): non-melanomatous skin cancers, low-risk prostate adenocarcinoma on active surveillance, or treated cancers in remission for the last 2 years.\n* Significant bleeding event within the last 6 months that places the patient at risk for bleeding due to the injection procedure based on Investigator assessment.",{"count":53,"type":20},[24],"The goal of this study is to understand the safety, tolerability, and potential efficacy of an injected immune therapy called RP2 to treat oral precancer conditions and prevent progression to an oral cancer.\n\nThe name of the study drug involved in this study is:\n\n-RP2 (a genetically modified live Herpes Simplex V-1 strain)",[85],"High-Risk Oral Precancerous Disease",[85,87],"Oral Precancerous Disease","2026-04-20",{"date":90,"type":36},"2026-04-23",{"date":92,"type":36},"2025-01-01",{"date":94,"type":20},"2029-01-01",{"name":42,"class":43},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":72},"100578001","phase-2-a-phase-2-trial-of-ivonescimab-for-patients-with-advanced-metastatic-salivary-gland-cancers-100578001","NCT06805617","A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers","A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers (I-MAC)","I-MAC","Inclusion Criteria:\n\n* Participants must have histologically confirmed salivary gland carcinoma (any histologic subtype, including ACC) with evidence of recurrent, metastatic, or advanced, unresectable disease.\n* Willing to provide tumor tissue from a diagnostic biopsy or prior surgery if deemed safe and feasible by the investigator.\n* Age 18 years or older at the time of consent. There is no upper age limit restriction in an effort to include patients across the lifespan.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participant must have organ and marrow function as defined below within 14 days prior to study registration:\n\n  * Absolute neutrophil count (ANC) ≥1000\u002FmcL\n  * Hemoglobin ≥8.5 g\u002FdL (with no blood transfusions within 7 days of start of therapy)\n  * Platelets ≥100,000\u002FmcL\n  * Liver function:\n\n    * Serum total bilirubin (T-bili) ≤1.5× upper limit of normal (ULN); for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, T-bili ≤3× ULN\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; for patients with liver metastases, AST and ALT ≤5× ULN\n  * Creatinine Within normal limits, or Creatinine clearance (CrCl) ≥50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by BSA is not required for eGFR)\n  * Urine protein: Urine protein \\\u003C2+ or 24-hour urine protein quantification \\\u003C1.0 g\n  * Coagulation:prothrombin time (PT) or international normalized ratio (INR) ≤1.5× ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5× ULN (unless abnormalities are unrelated to coagulopathy or coagulation)\n* Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study registration (progression of disease over any interval is allowed) and\u002For new or worsening disease-related symptoms within 12 months prior to study registration. This assessment is performed by the treating investigator. Evidence of progression by RECIST v1.1 criteria is not required.\n* Participants must have at least one RECIST v1.1 measurable non-CNS based lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥1 cm with CT scans or MR imaging.\n* Prior systemic therapy: At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (3 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE Version 5.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy). Any number of prior therapies for recurrent\u002Fmetastatic SGC are permitted except receipt of a prior oral VEGFR TKI or anti-PD-1 therapy; but prior therapy for recurrent\u002Fmetastatic SGC is not required for participation.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication.\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of the Ivonescimab.\n* Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until Day 120 after the last dose of Ivonescimab.\n\nExclusion Criteria:\n\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment) and have no evidence of new or enlarging brain metastases.\n* Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Pregnant or lactating women as the effects of the investigational therapy (ivonescimab) on the developing human fetus are unknown.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low- risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.\n* Existing significant autoimmune conditions. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded. Patients cannot be on long-term (\\>4 weeks) corticosteroids at doses exceeding prednisone 10 mg daily (or its equivalent).\n* Major surgical procedures or serious trauma within 4 weeks prior to starting therapy or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) are permitted.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to the start of therapy, including but not limited to:\n\n  * a. Gastrointestinal bleeding\n  * b. Hemoptysis (defined as coughing up ≥0.5 teaspoon of fresh blood or small blood clots). Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * c. Significant nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  * d. Need for therapeutic anticoagulant therapy within 14 days prior to the start of therapy.\n* Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy.\n* History of major diseases , specifically:\n\n  * a. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * b. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomization\n  * c. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to randomization\n  * d. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomization\n  * e. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization\n* Imaging during the screening period shows that the patient has:\n\n  * a. Radiologically documented evidence of major blood vessel invasion or encasement by cancer (per the judgment of the treatment investigator)\n  * b. Radiographic evidence of intratumor cavitation (per the judgment of the treating investigator)",{"count":105,"type":20},35,[24],"The goal of this study is to evaluate the efficacy and safety of Ivonescimab in participants with advanced, metastatic salivary gland cancers.\n\nThe name of the study drug involved in this study is:\n\n-Ivonescimab (a type of antibody)",[109,110,111,27],"Salivary Gland Cancer","Advanced Salivary Gland Carcinoma","Metastatic Salivary Gland Cancer",[109,113,111,27],"Salivary Gland Carcinoma","2025-07-28",{"date":116,"type":36},"2025-07-29",{"date":118,"type":36},"2025-02-26",{"date":120,"type":20},"2027-07-01",{"name":42,"class":43},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":139,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":72},"100588344","phase-2-toripalimab-with-chemotherapy-for-sinus-cancer-100588344","NCT06940180","Toripalimab With Chemotherapy for Sinus Cancer","Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed locoregionally advanced nasal cavity or paranasal sinus cancer including the following histologic subtypes: squamous cell carcinoma (SCC) of any morphologic variation: verrucous, papillary, basaloid, spindle cell, and adenosquamous; or sinonasal undifferentiated carcinoma (SNUC).\n* Participants with SCC should have resectable disease at baseline per the discretion of the treating surgical oncologist(s). \\*Participants with SNUC can have operable or borderline resectable (definition: resection would been morbid requiring extensive surgery and would have chances of incomplete gross total resection) disease as judged by the treating surgical oncologist(s).\n* Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):\n\n  * T2, N1-3 III\n  * T3, any N III, IVA, IVB\n  * T4, any N IVA, IVB\n* Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1000\u002FmcL\n  * Platelets ≥100\n  * Total bilirubin ≤institutional upper limit of normal (ULN)\n  * AST(SGOT) \u002F ALT (SGPT) ≤3x ULN\n  * Creatinine ≤institutional ULN or GFR of ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2\n* Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Contraception use should be maintained until at least 6 months after the last dose of chemotherapy for females and 3 months for males. In addition, contraception use should continue until 4 months after last dose of toripalimab for both males and females.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants with nasal cavity or paranasal sinus malignancies demonstrating histologies other than SCC or SNUC in the opinion of the reviewing pathologist. Excluded subtypes include: angiosarcomas, rhabdomyosarcomas, lymphomas, olfactory neuroblastomas (esthesioneuroblastomas), melanomas, and meningiomas among others. SNEC or sinonasal neuroendocrine carcinoma is not permitted.\n* Participants with unresectable or inoperable disease as judged by the treating surgical oncologist(s).\n* Participants with known distant metastatic disease (M1 or IVC).\n* Has received prior therapy with an anti-PD-1\u002FL1 agent or any other agent directed to another stimulatory or co-inhibitory T-cell receptor.\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Non-live vaccines are permitted.\n* Carries a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Exceptions may be permitted at the discretion of the overall Sponsor-Investigator.\n* Has an active autoimmune disease that has required systemic treatment in past 6 months (with use of a disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.\n* Has a history of (non-infectious) pneumonitis or interstitial lung disease that required steroids or has current pneumonitis or interstitial lung disease.\n* Has a known history of human immunodeficiency virus (HIV) infection that is uncontrolled. No HIV testing is required unless mandated by local health authority. Patients with well controlled HIV may be eligible if their CD4 T cell count is favorable and their HIV viral load is undetectable.\n* Has a known history of active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a history of allogeneic tissue or solid organ transplant.\n* Women who are pregnant or breastfeeding.",{"count":130,"type":20},20,[24],"The aim of this research study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab, with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers.\n\nThe names of the study drugs used in this research study are:\n\n* Toripalimab (a type of monoclonal antibody)\n* Carboplatin (a type of antineoplastic agent)\n* Docetaxel (a type of antineoplastic agent)\n* Cisplatin (a type of antineoplastic agent)",[134,135,136,137,138],"Sinonasal Cancer","Paranasal Sinus Neoplasms","Squamous Cell Carcinoma","Sinonasal Undifferentiated Carcinoma","Locally Advanced Head and Neck Cancer",[140,136,137,138,141,142,134],"Paranasal Sinus Neoplasm","Advanced Sinonasal Cancer","Advanced Paranasal Sinus Cancer","2025-06-25",{"date":145,"type":36},"2025-06-26",{"date":147,"type":36},"2025-06-17",{"date":149,"type":20},"2029-02-01",{"name":42,"class":43},""]