[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-carcinosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-carcinosarcoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,87,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100335729","phase-2-recurrent-ovarian-carcinosarcoma-anti-pd-1-niraparib-100335729",false,"NCT03651206","Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib","An International Multicentric Randomized Phase II Evaluating Dostarlimab in Combination With Niraparib Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy","ROCSAN","Inclusion Criteria:\n\n1. Progressive or recurrent uterine carcinosarcoma (Malignant Mixed Mullerian Tumor-MMMT).\n2. The primary diagnosis must be histologically confirmed by pathological expert review of the initial tumor or biopsy at relapse.\n3. Mandatory tumor samples: Availability of an archival FFPE tumor sample(s) from diagnosis, or if not available from relapse setting.\n4. Progressive disease as defined by RECIST 1.1.\n5. Failure after ≥1 prior platinum containing regimen, which may have been given in the adjuvant setting.\n6. Patient must have had 1 prior chemotherapeutic regimen for management of carcinosarcoma that may have included chemotherapy, chemotherapy and radio-chemotherapy, and\u002For consolidation\u002Fmaintenance therapy.\n7. Patient must be free of active infection requiring antibiotics.\n8. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to beginning protocol treatment; continuation of hormone replacement therapy is permitted.\n9. Patient must have ECOG Performance Status ≤1.\n10. Life expectancy of \\> 2 months.\n11. Adequate bone marrow function:\n\n    * Platelet count greater than or equal to 100,000\u002Fmm3\n    * Absolute neutrophil count (ANC) greater than or equal to 1,500\u002Fmm3\n    * Hemoglobin \\> 9g\u002FdL\n12. Adequate hepatic and renal function:\n\n    * Total bilirubin ≤1.5x Upper Limit of Normal (ULN) unless liver metastases are present, in which case they must be ≤3x ULN (≤2.0 in patients with known Gilberts syndrome OR direct bilirubin ≤ 1 x ULN)\n    * Serum creatinine ≤1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL\u002Fmin using Cockcroft-Gault equation\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN unless liver metastases are present, in which case they must be ≤5x ULN\n    * Alkaline phosphatase \\\u003C 2.5 times ULN\n    * Serum albumin \\> 3 g\u002FdL\n13. International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.\n14. Patient must have normal BP or adequately treated and controlled hypertension (systolic BP≤140 mmHg and\u002For diastolic BP ≤90 mmHg)\n15. Patient receiving corticosteroids may continue as long as their dose is stable and ≤10mg\u002Fday (prednisone equivalent) for at least 4 weeks prior to initiating protocol therapy.\n16. Patient must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\n17. Patient has a negative urine or serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 4 monhs after the last dose of study treatment, or is of nonchildbearing potential.\n\n    * Non-childbearing potential is defined as follows:\n\n      * ≥45 years of age and has not had menses for \\>1 year\n      * Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n      * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n    * For women of childbearing potential: the patient must be willing to use a highly effective contraception measure throughout the study, starting with the screening visit through 4 months after the last dose of study treatment. See Section 4.3. for a list of highly effective contraception methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n18. Patient must agree to not breastfeed during the study and for 4 months after the last dose of study treatment.\n19. Patient able to take oral medications.\n20. Female aged ≥18 years at time of signing ICF.\n21. Patient must have signed an approved informed consent.\n22. For France only: patient affiliated to, or a beneficiary of, a social security category.\n\nExclusion Criteria:\n\n1. Not enrolled in any interventional clinical trial (except to biological trials that must be validated by the sponsor)\n2. Prior treatment with niraparib or other PARPi therapy or PD1\u002FPDL-1 inhibitors.\n3. Patient has had investigational therapy, immunotherapy, chemotherapy or biological therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to treatment initiation. Patient has had radiotherapy within 4 weeks prior to treatment initiation.\n4. Patients must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects\n5. Patient who has received more than 3 prior cytotoxic chemotherapies for management of uterine carcinosarcoma.\n6. Patient with persistent, clinically significant \\> Grade 1 toxicity.\n7. Patient has clinically significant cardiovascular disease (eg, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina \\\u003C 6 months to enrollment, NYHA grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident within 6 months)\n8. Patient with any other severe concurrent disease, which may increase the risk associated with study participation or study drug administration and, in the judgment of the investigator, would make the patient inappropriate for entry into this study, including significant neurologic, psychiatric, infectious, hepatic, renal, or gastrointestinal diseases or laboratory abnormalities. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n9. Symptoms or signs of gastrointestinal obstruction requiring parenteral nutrition or hydration or any other gastro-intestinal disorders or abnormalities, including difficulty swallowing, that would interfere with drug absorption.\n10. Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities\n11. Participant has had radiation therapy encompassing \\>20% of the bone marrow within 2 weeks prior to Day 1 of protocol therapy or any radiation therapy within 1 week prior to Day 1 of protocol therapy.\n12. Patient has a diagnosis of immunodeficiency or has received systemic steroid therapy \\>10mg\u002Fday (prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy\n13. Participants with known HIV infection are allowed with the following requirements:\n\n    Documented evidence of plasma HIV-1 RNA persistently \\\u003C50 copies\u002FmL ≤3 months prior to AND at Screening. In the \\>3 to 12 months prior to Screening, plasma HIV-1 RNA consistently \\\u003C50 c\u002FmL required; if single increases ≥50 c\u002FmL occurred, they cannot have been persistent nor associated with antiretroviral resistance per investigator assessment AND CD4 cell count \\>350 cells\u002Fmm3 over past 12 months and at Screening (and no measurement ≤350 cells\u002Fmm3 during that time period) AND Must be on an uninterrupted combination antiretroviral therapy regimen for at least 3 months prior to Screening, with combination antiretroviral therapy regimen consistent with locally recommended guidelines Participants with history of CDC Stage 3 AIDS-defining disease (CDC, 2014; also known as acquired immunodeficiency syndrome - defining disease) are allowed if AIDS-defining disease has been treated and cured or is stable for ≥3 months prior to study entry. Cutaneous Kaposi's sarcoma not requiring systemic therapy is allowed.\n\n    No history of HIV-associated non-Hodgkin lymphoma ≤5 years prior to study entry.\n\n    No treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening\n14. Patient has known active hepatitis B (e. g., hepatitis B surface antigen \\[HBsAg\\] reactive and HBcAb reactive) or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[qualitative\\] is detected).\n15. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, 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.\n16. Patient must not have a history of interstitial lung disease.\n17. Patient has received a live vaccine within 30 days of initiating protocol therapy.\n18. Patient must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.\n19. Patient must not have received colony-stimulating factors (e.g, granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.\n20. Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)\n21. Symptomatic CNS metastasis or leptomeningeal carcinomatosis.\n22. Patients with a history of other invasive malignancies (any evidence of other malignancy being present within the last 3 years) or with a concomitant invasive malignancy, with the exception of non-melanoma skin cancer; patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy.\n23. Known hypersensitivity reactions or allergy to investigational drugs or their excipients that contraindicates the subject's participation.\n24. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; those considerations should be discussed with the patient before registration in the trial.\n25. Patients under psychiatric care and patients admitted to a health or social institution.\n26. Patients deprived of their liberty by judicial or administrative decision.\n27. Patients under a legal protection measure or unable to express their consent.","FEMALE","18 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases\u002F100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) \\\u003C 10% and a poor prognosis. After initial treatment (surgery +\u002F- adjuvant radiotherapies +\u002F- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is \\\u003C20%, progression-free survival (PFS) \\\u003C4 months, and OS \\\u003C1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.",[28,29],"Ovarian Carcinosarcoma","Endometrial Carcinosarcoma",[31,32,33,34,35,36,37],"Malignant mixed Mullerian tumors","Metastatic ovarian carcinosarcoma","Recurrent ovarian carcinosarcoma","Metastatic endometrial carcinosarcoma","Recurrent endometrial carcinosarcoma","Niraparib","TSR-042 (Dostarlimab)","RECRUITING","2026-05-28",{"date":41,"type":42},"2026-06-01","ACTUAL",{"date":44,"type":42},"2020-07-15",{"date":46,"type":21},"2029-03",{"name":48,"class":49},"ARCAGY\u002F GINECO GROUP","OTHER",36,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100433092","phase-2-apl-2-and-pembrolizumab-versus-apl-2-pembrolizumab-and-bevacizumab-versus-bevacizumab-alone-for-the-treatment-of-recurrent-ovarian-fallopian-tube-or-primary-peritoneal-cancer-and-malignant-effusion-100433092","NCT04919629","APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion","Randomized Phase 2 Trial of APL-2 With Pembrolizumab vs. APL-2 With Pembrolizumab and Bevacizumab vs. Bevacizumab Alone in Patients With Recurrent Ovarian Cancer and Persistent Malignant Effusion","Inclusion Criteria:\n\n* Age \\>= 18 years of age on day of signing informed consent\n* Recurrent epithelial ovarian\u002Ffallopian tube or primary peritoneal cancer (serous, clear cell, endometrioid, mixed or poorly differentiated or carcinosarcoma) based on imaging or synchronous primary ovarian and uterine cancer patients with any of the histology subtypes mentioned above regardless of platinum sensitivity, prior stage or number of prior treatment lines\n* Symptomatic ascites or pleural effusion or both requiring \\>= 1 drainage within 4-weeks of study entry or has a peritoneal\u002Fpleural drainage catheter in place to control symptoms\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patient has not received pembrolizumab or other immune checkpoint inhibitor treatment for 9 weeks prior to enrollment\n* Life expectancy of \\>= 3 months\n* Absolute neutrophil count (ANC): \\>= 1,500\u002FµL\n* Platelets: \\>= 75,000\u002FµL\n* Hemoglobin: \\>= 9 g\u002FdL or 5.6 mmol\u002FL (within 7 days of assessment)\n* Creatinine: =\\\u003C 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance \\>= 60 mL\u002Fmin (Cockcroft-Gault Equation) for participant with creatinine levels \\> 1.5 X institutional ULN. GFR can also be used in place of creatinine or creatinine clearance (CrCl)\n* Total bilirubin: =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for participants with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]): =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for participants with liver metastases\n* Albumin: \\> 2.5 gm\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT): =\\\u003C 1.5 unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants\n* Activated Partial Thromboplastin Time (aPTT): =\\\u003C 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* A woman of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year). Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately\n* Willing and able to self-administer APL-2 (administration by caregiver will be allowed)\n* No known absolute contraindication to bevacizumab and\u002For pembrolizumab treatment per enrolling provider\n* Willing to receive vaccination against Neisseria meningitidis, Streptococcus pneumoniae, and Hemophilus influenzae if randomized into an APL-2 receiving arm, if not already vaccinated\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Is currently receiving any additional cancer therapy or participating or used an investigational drug or device within 3 weeks of the first dose of treatment\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or, is taking any other medication that might affect immune function\n* Has active autoimmune disease that has required systemic treatment in the past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Participant has clinically significant cardiovascular disease including:\n\n  * Uncontrolled hypertension, defined as systolic \\>150 mmHg or diastolic \\>90 mmHg\n  * Myocardial infarction or unstable angina within 6 months prior to enrollment\n  * New York Heart Association (NYHA) Grade II or greater congestive heart failure\n  * Participant has a Grade II (NYHA) or greater peripheral vascular disease\n  * Participant has a clinically significant peripheral artery disease (e.g. those with claudication), within 6 months prior to study enrollment\n* Pregnancy or lactation\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has a known history of human immunodeficiency virus (HIV) infection\n* Concurrent active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] positive and\u002For detectable HBV deoxyribonucleic acid \\[DNA\\]) and hepatitis C virus (HCV) (defined as anti-HCV Ab positive and detectable HCV ribonucleic acid \\[RNA\\]) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection\n* Has received any investigational vaccines (i.e., those not licensed or approved for emergency use). Note: Any licensed COVID-19 vaccine (including for Emergency Use) is allowed in the study as long as they are modified ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (i.e., those not licensed or approved for emergency use) are not allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded",{"count":59,"type":21},60,[24],"This phase II trial studies the effect of APL-2 when given in combination with either pembrolizumab or pembrolizumab and bevacizumab compared with bevacizumab alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) and a buildup of fluid and cancer cells (malignant effusion). APL-2 may limit tumor progression, decrease malignant effusion production, and improve the immune system's response against cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving APL-2 together with either pembrolizumab or pembrolizumab and bevacizumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer and malignant effusion compared to bevacizumab alone.",[63,64,65,66,28,67,68,69,70,71,72,73,74,75,76],"Fallopian Tube Carcinosarcoma","Fallopian Tube Clear Cell Adenocarcinoma","Fallopian Tube Endometrioid Adenocarcinoma","Fallopian Tube Serous Adenocarcinoma","Ovarian Clear Cell Adenocarcinoma","Ovarian Endometrioid Adenocarcinoma","Ovarian Serous Adenocarcinoma","Primary Peritoneal Carcinosarcoma","Primary Peritoneal Clear Cell Adenocarcinoma","Primary Peritoneal Endometrioid Adenocarcinoma","Primary Peritoneal Serous Adenocarcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","2026-03-19",{"date":79,"type":42},"2026-03-23",{"date":81,"type":42},"2023-04-27",{"date":83,"type":21},"2028-04-30",{"name":85,"class":49},"Roswell Park Cancer Institute",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":110,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100508635","phase-1-a-phase-iii-study-of-vls-1488-in-subjects-with-advanced-cancer-100508635","NCT05902988","A Phase I\u002FII Study of VLS-1488 in Subjects With Advanced Cancer","A Phase I\u002FII Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer","Key Inclusion Criteria:\n\n* All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration\n* Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non -Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian Carcinosarcoma, CN-high Endometrial\u002FUterine\n* Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), CN-high Endometrial\u002FUterine\n\nKey Exclusion Criteria:\n\n* MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype\n* Previously received KIF18A inhibitor\n* Current CNS metastases or leptomeningeal disease\n* Cardiac parameters: MI or stroke ≤ 1 year, unstable angina\u002FPE\u002FDVT\u002FCABG ≤ 6 months, NYHA Class ≥ II, LVEF \\\u003C 50%\n* Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP\n* Any clinically significant ascites or pleural effusions at time of enrollment, or any therapeutic paracentesis or thoracentesis within 28 days of planned first dose of study drug\n* Bowel obstruction or GI perforation within 6 months of planned first dose of study drug","ALL",{"count":96,"type":21},200,[98,24],"PHASE1","This is a first-in-human phase I\u002FII study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.",[101,102,103,104,105,28,106,107,108,109],"Advanced Solid Tumor","High Grade Serous Adenocarcinoma of Ovary","Squamous Non-small-cell Lung Cancer","Triple Negative Breast Cancer","Head and Neck Squamous Cell Carcinoma","Uterine Carcinosarcoma","Uterine Serous Carcinoma","Endometrium Cancer","Chromosomal Instability",[111,112,113,114,115],"KIF18A Inhibitor","HGSOC","TNBC","HNSCC","sqNSCLC","2025-10-31",{"date":118,"type":42},"2025-11-04",{"date":120,"type":42},"2023-10-18",{"date":122,"type":21},"2026-12",{"name":124,"class":125},"Volastra Therapeutics, Inc.","INDUSTRY",14,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":146,"locationsCount":148},"100486887","phase-2-epoch-eribulin-and-pembrolizumab-in-ovarianuterine-carcinosarcoma-100486887","NCT05619913","EPOCH: Eribulin and Pembrolizumab in Ovarian\u002FUterine Carcinosarcoma","The EPOCH Study: Phase II Open Labelled Study Investigating the Use of Single Agent Eribulin and Eribulin in Combination With Pembrolizumab in Relapsed Tubo-ovarian or Uterine Carcinosarcoma","EPOCH","Inclusion Criteria:\n\n1. Provision of written informed consent prior to any study specific procedures and the ability to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.\n2. Patients \\> 18 years old who have a histologically confirmed tubo-ovarian carcinosarcoma or uterine carcinosarcoma with evidence of recurrence or progression. The component of sarcoma in the diagnostic pathology sample must be equal to or \\> 5% of tumour.\n3. Must have Positron Emission Tomography (PET), Computerized Tomography CT, or Magnetic Resonance Imaging (MRI) -proven relapsed disease after completion of at least one line and not more than two lines of chemotherapy.\n4. Must have at least one evaluable measurable lesion (other than the lesion that will be used for biopsy) using standard techniques according to the Response Evaluation Criteria in Solid Tumours (RECIST v1.1) guidelines (Appendix 1).\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (Appendix 5). Evaluation of ECOG is to be performed within 28 days prior to the first dose of the study intervention.\n6. Have adequate organ function as defined below (refer also Appendix 6).\n\n   * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n   * Platelets ≥100 x 109\u002FL\n   * Haemoglobin (Hb) ≥90 g\u002FL or ≥5.6 mmol\u002FL (criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks).\n   * Creatinine ≤ 1.5 x Upper Limit Normal (ULN); OR Creatinine Clearance (CrCl) ≥ 30 mL\u002Fmin (calculated per institutional standard) for participants with creatinine levels \\>1.5 ULN (glomerular filtration rate, GFR, can also be used in place of creatinine or CrCl). (Patients with moderate renal impairment (CrCl 30-49ml\u002Fmin) will receive a 25% reduced dose of eribulin).\n   * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n   * Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n   * 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 Biological specimens must be collected within 28 days prior to the first dose of the study intervention (within 7 days, where indicated in the SoA).\n7. Available formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer and\u002For metastatic tumour from the up-front or secondary debulking surgery with adequate neoplastic cell content (\\>30%).\n8. Must have disease amenable to biopsy and must be willing to undergo a paired biopsy for additional correlative analyses (the first biopsy to be performed within 28 days prior to the start of the study intervention and the second biopsy in the five-day window prior to Cycle 2 (post Cycle 1)). For patients that experience progression of their disease whilst on study, separate patient consent will be sought for additional biopsies of their tumour for research.\n9. Willing to have blood samples collected for translational research\n10. Must not be pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    1. Not a person of childbearing potential (POCBP). OR\n    2. A POCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 months (120 days) after the last dose of the study treatment.\n\nExclusion Criteria:\n\n1. Prior line of treatment involving immunotherapy 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. This criteria is applicable for both intervention arms as patients may cross-over from the non-immunotherapy arm during their study participation.\n2. Prior treatment with eribulin for any malignancy.\n3. Absence of a second disease site suitable for biopsy\n4. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the first dose of the study intervention.\n5. Has active autoimmune disease (such as Systemic Lupus Erythematosus) that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n6. A POCBP who has a positive urine pregnancy test within 7 days prior to the first dose of the study intervention (see Appendix 7). If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n7. Has received prior radiotherapy within 2 weeks of the start of the study intervention. Patients 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-central nervous system disease.\n8. Known central nervous system malignancy or metastasis, including leptomeningeal metastasis or carcinomatous meningitis, unless adequately treated and patients are neurologically stable for at least one month prior to enrolment. Patients must be either off corticosteroids or on stable or decreasing dose of \\\u003C \u002F=10 mg daily prednisone (or equivalent) within 28 days prior to the first dose of the study intervention. In the case of short-term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg daily of prednisone or an equivalent corticosteroid, the required washout period prior to starting the first dose of the study intervention is 7 days. Anticonvulsants are allowed to be continued except for those which interfere with the study interventions or are associated with liver toxicity. However, patients receiving anticonvulsants must be discussed with Study Chair or Acting Chair of Trial Management Committee (TMC) prior to their enrolment to the study.\n9. Symptomatic or clinically significant inflammatory bowel disease (Crohn's disease or ulcerative colitis).\n10. 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 therapy within 7 days prior to the first dose of the study intervention.\n11. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of the study intervention. Live vaccine or live-attenuated vaccine cannot be administered during treatment with the study intervention and for 30 days post discontinuation of the study intervention. Administration of killed vaccines is allowed.\n12. Has an active infection requiring systemic therapy.\n13. Has had an allogenic tissue\u002Fsolid organ transplant.\n14. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n15. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n16. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: no testing for HIV is required unless mandated by local health authority.\n17. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\> 25 international units\u002FmL is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n18. Has a known additional active malignancy that is likely to interfere with assessment of response or tolerance to the study intervention.\n19. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patients' participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n20. Inability to attend or comply with treatment or follow-up scheduling.",{"count":136,"type":21},30,[24],"The EPOCH study population is patients with tubo-ovarian carcinosarcoma or uterine carcinosarcoma with evidence of recurrence or progression.\n\nThe study aims to determine the activity of eribulin as a single agent and the combination of eribulin and pembrolizumab as measured by clinical benefit rate (CBR) at 12 weeks.\n\nAdditionally, the study aims to establish whether high mobility group A2 (HMGA2) protein expression is a good functional biomarker to predict response to eribulin and pembrolizumab.",[28,106],"2025-02-02",{"date":142,"type":42},"2025-02-04",{"date":144,"type":42},"2023-05-22",{"date":122,"type":21},{"name":147,"class":49},"Australia New Zealand Gynaecological Oncology Group",6]