[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pembrolizumab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pembrolizumab":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,76,102,128,152],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100614756","phase-2-phase-2-trial-of-zanzalintinib-and-pembrolizumab-in-select-subtypes-of-advancedmetastatic-soft-tissue-sarcoma-100614756",false,"NCT07283731","Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced\u002FMetastatic Soft-tissue Sarcoma","Eligibility Criteria\n\n* Participants must have histologically or cytologically confirmed undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), high grade pleomorphic (HGPS) or undifferentiated sarcoma (HGUS).\n* Participant ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of zanzalintinib in combination with pembrolizumab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤2 (Karnofsky ≥60%).\n* Participants must have measurable disease, 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) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n* At least 4 weeks since prior chemotherapy.\n* At least 2 weeks since radiation therapy for bone metastases, any other radiation therapy within 4 weeks before first dose of study treatment. At least 6 weeks since systemic treatment with radionuclides before first dose of study treatment.\n* Participants must have adequate organ and marrow function as defined below within 14 days before first dose of study treatment:\n\nabsolute neutrophil count ≥1,500\u002FmcL without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.\n\nplatelets ≥100,000\u002FmcL without transfusion within 2 weeks of screening laboratory sample collection.\n\nhemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL) without transfusion within 2 weeks prior to screening laboratory sample collection.\n\ninternational normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN ).\n\ntotal bilirubin ≤ 1.5 x institutional ULN AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN Alkaline phosphatase (ALP) ≤3 × institutional ULN, . For subjects with documented bone metastasis ALP ≤ 5 x ULN.\n\ncreatinine ≤ 1.5 x institutional ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the Cockcroft Gault equation.\n\nUrine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol)\n\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 4 weeks. Note: Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first three cycles of therapy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of zanzalintinib and pembrolizumab on the developing human fetus are unknown. For this reason, women of child-bearing potential 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  o Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n\n  o History of hysterectomy or bilateral salpingo-oophorectomy.\n\n  o Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n  o History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  o Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n* Females must not be pregnant.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n* Women of childbearing potential must comply for the duration of study participation and through 186 days after the last dose of zanzalintinib and 180 days after the last dose of pembrolizumab, whichever date is later. Men must comply for the duration of study participation and through 96 days after the last dose of zanzalintinib or 96 days of pembrolizumab, whichever date is later.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Consent to MD Anderson companion laboratory protocol 2014-0938 for correlative analyses of biopsies obtained in this trial.\n\nExclusion Criteria\n\n* Prior treatment with immune checkpoint inhibitors (ICIs)\n* Prior treatment with zanzalintinib\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible. Additionally, if participants have received radiation therapy within 4 weeks or systemic therapy with radionucleotides within 6 weeks they are not eligible.\n* Participants who are receiving any other investigational agents, as well as cytotoxic or biological systemic anticancer therapy including investigational treatments within 4 weeks of initiating study treatment are excluded.\n* Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel).\n\n  * Allowed anticoagulants are the following:\n\n    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\nUnstable of deteriorating cardiovascular disorders • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsade's de pointes).\n\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n* Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\nNote: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n\no Prior history of myocarditis.\n\nGastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n* Tumors invading the GI-tract from external viscera.\n* Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n* Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n* Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n* Known gastric or esophageal varices.\n* Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n  * Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n  * Tumors invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior vena cava) may be eligible following Principal Investigator approval.\n  * Other clinically significant disorders that would preclude safe study participation.\n* Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n* Malabsorption syndrome.\n* Pharmacologically uncompensated, symptomatic hypothyroidism.\n* Moderate to severe hepatic impairment (Child-Pugh B or C).\n* Requirement for hemodialysis or peritoneal dialysis.\n* History of solid organ or allogeneic stem cell transplant.\n\n  * Participants with brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 3 months.\n  * History of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib or pembrolizumab or other agents used in study.\n  * Moderate or strong CYP3A4 inhibitors (see section 5.4).\n  * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load and CD4+ T cell count ≥ 200\u002FµL within 6 months are eligible for this trial.\n* Note: To be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n\n  * Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  * Pregnant women are excluded from this study because zanzalintinib has the potential for teratogenic or abortifacient effects based on its mechanism of action. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zanzalintinib and pembrolizumab, breastfeeding should be discontinued if the mother is treated with either agent. These potential risks may also apply the other agents used in this study.\n  * Major surgery (as defined in Appendix 2) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (ie nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\nNote: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n\n• Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\nNote: Triplicate ECG evaluations one minute apart will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n\n* Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n* Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* Suspected autoimmune disease, or active or prior documented autoimmune disease within the last 2 years.\n\nNote: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n\n* Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after Principal Investigator approval.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed. Note: Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of higher doses of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.\n* Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participant's ability to complete the study.","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To learn if zanzalintinib and pembrolizumab can help to control select subtypes of advanced\u002Fmetastatic soft-tissue sarcoma (UPS, MFS, HGPS, and HGUS",[25,26,27,28,29],"Phase 2","Zanzalintinib","Pembrolizumab","Advanced\u002FMetastatic","Soft-Tissue Sarcoma","RECRUITING","2026-04-14",{"date":33,"type":34},"2026-04-17","ACTUAL",{"date":36,"type":19},"2026-06-02",{"date":38,"type":19},"2030-11-01",{"name":40,"class":41},"M.D. Anderson Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100624454","phase-2-neoadjuvant-immunotherapy-and-organ-sparing-treatment-in-patients-with-stage-i-iii-dmmr-colon-cancer-100624454","NCT07409844","Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer","Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)","RESET C2","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Written informed consent\n3. Clinical UICC stage I-III dMMR colon carcinoma\n4. Indication for elective curative-intent surgery\n5. ECOG status 0-2\n\nExclusion Criteria:\n\n1. Patients deemed to be non-surgical candidates by MDT\n2. Patients with a need for emergent surgery due to tumour obstruction\n3. Contraindications to pembrolizumab, including allergy and hypersensitivity reactions, assessed by the study investigator(s)\n4. Any serious or uncontrolled medical disorder, including other malignant disease, that may increase the risk associated with participation or drug administration.\n5. Patients with colonic stents\n\nAdditional Circumstances:\n\nIn the following circumstances, eligibility will be individually verified:\n\n* Synchronous colonic tumours (may be included if other lesions are biopsy-verified with dMMR status)\n* Concurrent tumours (e.g., patients with prostate cancer may be included if this does not hinder their other cancer treatment or assessments of efficacy)\n\nIn the following circumstance patients may be excluded from the PROMs outcomes:\n\n* Danish language skills insufficient to answer PROMs\n* Unable to use eBoks",{"count":52,"type":19},152,[22],"The RESET C2 trial aims to introduce organ sparing treatment or watch-and-wait (WW) to patients with localized deficient mismatch repair (dMMR) colon cancer through use of neoadjuvant pembrolizumab. Patients will be divided into four treatment arms based on their surgical and oncologic risks. Each arm provides different intensity neoadjuvant immunotherapy regimens. Patients with complete response at disease restaging procedures will be offered non-operative management, whereas those with non-complete response will proceed to surgery ± adjuvant chemotherapy as standard of care. A WW protocol with regular disease surveillance continues over survivorship. If there is recurrence, surgery and\u002For appropriate oncologic therapy will be offered determined by multi-disciplinary teams. This is a national, non-randomised, investigator-initiated trial including patients from 13 hospitals across Denmark. The rationale, design, and clinical response metrics are derived from the RESET C study (NCT05662527) showing efficacy, safety and feasibility of neoadjuvant pembrolizumab in this cohort.",[56,57,58,27,59],"DMMR Colorectal Cancer","Colon Cancer Stage I","Colon Cancer Stage II\u002FIII","Immunotherapy",[27,61,62,63,64,65],"dMMR","colon cancer","watch-and-wait","organ sparing","neoadjuvant immunotherapy","NOT_YET_RECRUITING","2026-02-17",{"date":69,"type":34},"2026-02-20",{"date":71,"type":19},"2026-03-01",{"date":73,"type":19},"2031-01-01",{"name":75,"class":41},"Ismail Gögenur",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":16,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":20,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":42},"100613061","phase-2-phase-ii-study-of-weekly-paclitaxelnab-paclitaxel-pembrolizumab-and-mirabegron-for-recurrent-ovarian-cancer-100613061","NCT07261683","Phase II Study of Weekly Paclitaxel\u002FNab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian Cancer","A Phase II Study Evaluating the Efficacy and Safety of Weekly Paclitaxel or Nab-Paclitaxel Combined With Pembrolizumab and Mirabegron in Patients With Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Has provided documented informed consent for the study.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.\n* Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment).\n* Has a platinum-free interval (PFI) of \\\u003C 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of \\\u003C 12 months if the last regimen received is a non-platinum-based.\n* Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Has a life expectancy of ≥12 weeks.\n* Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening.\n* Has adequate organ function.\n* Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent.\n\nExclusion Criteria:\n\n* Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.\n* Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 \\[CTLA-4\\], tumor necrosis factor receptors OX-40 or CD137).\n* Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before enrollment.\n* Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to paclitaxel\u002Fnab-paclitaxel, pembrolizumab, mirabegron and any of their excipients.\n* Has undergone major surgery within 3 weeks before enrollment or has complications\u002Fsequelae that have not yet recovered.\n* Has a known additional malignancy that progressed or required active treatment within the last 5 years.\n* Is pregnant or breastfeeding.\n* Has a history of allogenic tissue\u002Fsolid organ transplant.\n* Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before enrollment.\n* Has a history of active autoimmune disease.\n* Has an active infection requiring systemic therapy.\n* Has a history of human immunodeficiency virus (HIV) infection.\n* Has a history of Hepatitis B or C virus infection.\n* Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.","FEMALE","75 Years",{"count":18,"type":19},[22],"The goal of this clinical trial is to learn if drug regimen weekly paclitaxel\u002Fnab-paclitaxel, pembrolizumab, and mirabegron works to treat relapsed ovarian cancer in adults. It will also learn about the safety of the drug regimen. The main questions it aims to answer are:\n\ni) Does drug weekly paclitaxel\u002Fnab-paclitaxel, pembrolizumab, and mirabegron reduce tumor volume? ii) What medical problems do participants have when taking drug weekly paclitaxel\u002Fnab-paclitaxel, pembrolizumab, and mirabegron?\n\nParticipants will:\n\ni) Take drug paclitaxel\u002Fnab-paclitaxel every week and pembrolizumab every 21 days with everyday mirabegron ii) Visit the clinic once every 2 months for checkups and tests iii) Keep a diary of their symptoms",[89,59,27],"Ovarian Cancer",[91,92],"ovarian cancer","immunotherapy","2025-12-14",{"date":95,"type":34},"2025-12-19",{"date":97,"type":19},"2025-12",{"date":99,"type":19},"2028-11-30",{"name":101,"class":41},"Obstetrics & Gynecology Hospital of Fudan University",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":20,"phases":112,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":42},"100546014","phase-2-phase-ii-study-of-moderate-dose-hypofractionated-rt-combined-with-pembrolizumab-for-hcc-with-diffuse-tumor-thrombosis-100546014","NCT06389422","Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis","Phase II Study of Moderate-dose Hypofractionated Radiotherapy Combined With Pembrolizumab for Hepatocellular Carcinoma With Diffuse Tumor Thrombosis Involved Both Left and Right Liver","Inclusion Criteria:\n\n1. Confirmed clinically or histopathologically as hepatocellular carcinoma, concurrently with portal vein thrombosis or hepatic vein thrombosis;\n2. Age 18-90 years;\n3. Liver-GTV volume\\\u003C700ml or the estimated volume of Liver-GTV receiving less than 5 Gy of irradiation\\\u003C300ml but the average dose of Liver-GTV needs to be \\\u003C18Gy;\n4. Allowed previous treatment including TACE, RFA, surgery, chemotherapy, targeted therapy, etc., but not including ICIs such as anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies;\n5. ECOG performance status 0-2, expected survival greater than 1 month;\n6. Allowing patients with distant metastases;\n7. Child-Pugh A5, A6, B7 and B8;\n8. ALT within 2.5 times the normal upper limit; AST within 2.5 times the normal upper limit; TBIL \\\u003C60umol\u002FL.\n9. No significant abnormalities in the electrocardiogram, no apparent heart failure, and no contraindications for anti-PD-1 treatment;\n10. CRE, BUN within 2.5 times the normal upper limit;\n11. Hb ≥ 50g\u002FL, ANC ≥ 0.5 × 10\\^9 \u002FL, PLT ≥ 30 × 10\\^9 \u002FL; patients with a history of gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment with Hb ≥ 60g\u002FL and a significant rising trend;\n12. Patients voluntarily participate in this clinical trial and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Currently participating in other clinical trials;\n2. Previously received abdominal radiotherapy or liver transplantation;\n3. Individuals with severe chronic disease conditions affecting vital organs such as the heart, kidneys, or liver;\n4. Severe ascites with noticeable symptoms, anticipated to be unrelieved after treatment.\n5. Suspected or confirmed drug addiction, medicine abuse,or alcoholism\n6. Pregnant or lactating women;\n7. Severe mental or neurological disorders\n8. Presence of other life-threatening malignancy within the last 3 years before the start of the study (excluding superficial skin cancer, localized low-grade malignant tumor and in situ carcinoma).","90 Years",{"count":111,"type":19},30,[22],"This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \\\u003C 700ml or estimated liver-GTV V5 \\\u003C 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy\u002F5f, and a maximum dose of 35Gy\u002F5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.",[115,116,27,117],"Hepatocellular Carcinoma","Radiotherapy","Tumor Thrombosis",[115,116,27,117],"2024-04-24",{"date":121,"type":34},"2024-04-29",{"date":123,"type":19},"2024-05-01",{"date":125,"type":19},"2027-04-30",{"name":127,"class":41},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":20,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":42},"100523952","phase-3-evaluating-the-efficacy-and-safety-of-pembrolizumab-plus-standard-chemotherapy-in-the-neoadjuvant-treatment-of-local-advanced-la-hnscc-100523952","NCT06102395","Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC","EFFECT-neo: A Prospective, Open-label, Multicenter Phase III Study to Evaluate Efficacy and Safety of Pembrolizumab Combined With Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC","Inclusion Criteria:\n\n1. Patients with stage IIIA-IVB head and neck squamous cell carcinoma confirmed by histology and\u002For cytology;\n2. Have not received immunotherapy in the past;\n3. The researchers believe that he can safely receive pembrolizumab combined with chemotherapy or neoadjuvant chemotherapy;\n4. Age ≥18 years;\n5. ECOG 0-2;\n6. Measurable disease as defined by RECIST v1.1;\n7. Organs function normally;\n8. Female and male participants of reproductive potential must agree to use appropriate contraception throughout the study period and for 180 days after the last study treatment;\n9. Male participants must not donate sperm throughout the study and for 180 days after the last study treatment.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis;\n2. Female subjects with a positive urine pregnancy test within 72 hours before the start of the study or within 24 hours after starting radiation therapy (with or without cisplatin);\n3. received a live vaccine within 30 days before enrollment;\n4. Diagnosed with immunodeficiency or receiving systemic steroid treatment or any other form of immunosuppressive treatment within 7 days before enrollment;\n5. Have imaging detectable (even if asymptomatic and\u002For previously treated) central nervous system metastases and\u002For cancerous meningitis;\n6. Have undergone surgery before commencing the study or have failed to recover adequately from toxicity or complications resulting from the intervention;\n7. Previous allogeneic tissue\u002Fsolid organ transplant;\n8. Severe hypersensitivity reaction (≥Grade 3) to pembrolizumab or any of its excipients, radiotherapy, platinum, paclitaxel, 5-FU or their analogs;\n9. Have an active autoimmune disease requiring systemic therapy in the past 2 years;\n10. History of (non-infectious) pneumonia requiring steroid treatment;\n11. Have a history of human immunodeficiency virus (HIV) infection;\n12. Have a history of hepatitis B or be positive for hepatitis B virus (defined as a positive reaction to hepatitis B surface antigen \\[HBsAg\\]) or active hepatitis C (defined as detection of hepatitis C virus \\[HCV\\] ribonucleic acid).\n13. Have any medical history, treatment, or laboratory abnormalities that could confound the study results, interfere with participant participation throughout the study, or be detrimental to the best interests of the participant (e.g., Hashimoto's thyroiditis, etc.);\n14. Have a known history of mental illness or substance abuse disorder",{"count":136,"type":19},272,[138],"PHASE3","This study is a prospective, open-label, multi-center phase III study; patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who meet the inclusion criteria are randomized 1:1 and given pembrolizumab 200 mg d1+ chemotherapy for 2 cycles (experimental group), 2 cycles of chemotherapy (control group), and then stratified according to the patient's condition. If the imaging evaluation after neoadjuvant treatment is (complete response, CR), adjuvant radiotherapy will be given; if the imaging evaluation is (partial response, PR) or (stable disease, SD), surgery (within 2 weeks) will be performed, followed by standard treatment. The main research hypothesis of this study: pembrolizumab combined with standard chemotherapy can significantly improve the rate of pathological complete response (pCR) compared with standard chemotherapy.",[141,142,27],"Head and Neck Squamous Cell Carcinoma","Neoadjuvant Therapy","2023-10-26",{"date":145,"type":34},"2023-10-30",{"date":147,"type":34},"2023-05-01",{"date":149,"type":19},"2030-04-30",{"name":151,"class":41},"Beijing Tongren Hospital",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":15,"minAge":159,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":20,"phases":162,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":42},"100461260","phase-1-phase-ibii-trial-of-combining-pembrolizumab-and-lenvatinib-with-sbrt-for-hcc-patients-with-portal-vein-thrombosis-100461260","NCT05286320","Phase Ib\u002FII Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.","Phase Ib\u002FII Trial of Combining Pembrolizumab and Lenvatinib With Stereotactic Body Radiotherapy for Hepatocellular Carcinoma Patients With Portal Vein Thrombosis.","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 20 years of age on the day of signing informed consent with histologically confirmed diagnosis of HCC or those diagnosed by the EASL non-invasive criteria for HCC will be enrolled in this study.\n2. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 220 days after the last dose of study treatment and refrain from donating sperm during this period.\n3. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n   2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.\n4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n5. Have measurable disease based on mRECIST.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n7. Have adequate organ function as defined in the following criteria (Specimens must be collected within 10 days prior to the start of study intervention) :(1)Absolute neutrophil count (ANC) ≥1500\u002FµL. (2)Platelets ≥100000\u002FµL. (3)Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL. (4)Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN. (5)Total bilirubin ≤1.5 ×ULN (mg\u002FdL) OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>2.5 × ULN (mg\u002FdL).(6)AST (SGOT) and ALT (SGPT) ≤5 × ULN. (7)Alkaline phosphatase ≤2 × ULN.(8)Child-Pugh class Class A. (9)International normalized ratio (INR) OR prothrombin time (PT)、Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n8. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to starting study intervention. Participants with HBV will be eligible as long as they meet the following criteria: (1) Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to starting study intervention. (2)Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n9. Patients have PVTT in the main trunk (VP4) or central branch (VP3).\n10. Previous liver resection, embolization, or ablative therapy is permitted.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to \\[allocation\\]. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-HCC therapy including investigational agents or other local therapy within 4 weeks prior to \\[allocation\\].\n4. Has received prior radiotherapy to non-liver sites within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive or modulation therapy within 7 days prior to the first dose of study drug.\n7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n8. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n9. Has severe hypersensitivity (≥Grade 3) to pembrolizumab\u002FLenvatinib and\u002For any of their excipients.\n10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n11. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n12. Has an active infection requiring systemic therapy.\n13. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n16. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n17. Has had an allogenic tissue\u002Fsolid organ transplant.\n18. Child-Pugh class B or C cirrhosis of liver.\n19. Patients with a history of selective internal radiation therapy (eg, microsphere radioembolization) or who have received radiotherapy to the abdominal area prior to the initiation of study treatment.\n20. Patients who have an inadequate hepatic reserve, as judged by the investigator; ie, normal liver tissue volume \\\u003C700 mL.\n21. Patients who fail to follow the radiation dose constraint of any critical organ.\n22. Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula.\n23. Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of study intervention.\n24. Has significant cardiovascular impairment within 12 months prior to the first dose of study intervention such as history of congestive heart failure greater than NYHA Class II, unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia associated with hemodynamic instability.\n25. Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention.\n\n    Note: f participant underwent major surgery, they must have adequately recovered from the toxicity and\u002For complications from the intervention prior to starting study intervention.\n26. Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of study intervention (Cycle 1 Day 1).\n27. Has serious nonhealing wound, ulcer, or bone fracture.\n28. Participants with proteinuria \\>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 g\u002F24 hours will be ineligible.\n29. Has prolongation of corrected QT (QTc) interval to \\>480 ms (corrected by Fridericia Formula) or is taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics (Quinidine, Procainamide, Disopyramide, Amiodarone, Sotalol, Ibutilide, Dofetilide \\& Dronedarone).\n30. Has LVEF below the institutional normal range as determined by MUGA or echocardiogram (ECHO).\n31. Has dual active HBV infection (HbsAg positive and \u002For detectable HBV DNA) and HCV infection (anti-HCV Ab positive and detectable HCV RNA) at study entry.\n32. Uncontrolled blood pressure \\> 140\u002F90 mmHg in spite of an optimal regimen of antihypertensive medication.","20 Years",{"count":161,"type":19},27,[163,22],"PHASE1","HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.",[166,27,167,168],"Unresectable Hepatocellular Carcinoma","Lenvatinib","Stereotactic Body Radiotherapy",[166,59,170,171],"Stereotactic body radiotherapy","targeted therapy","2023-02-28",{"date":174,"type":34},"2023-03-02",{"date":176,"type":19},"2023-03-01",{"date":178,"type":19},"2026-09-30",{"name":180,"class":41},"National Taiwan University Hospital"]