[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-platinum-resistant-ovarian-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-platinum-resistant-ovarian-carcinoma":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,84,105,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100512285","phase-1-testing-different-amounts-of-the-combination-of-drugs-m1774-and-zen-3694-for-the-treatment-of-recurrent-ovarian-and-endometrial-cancer-100512285",false,"NCT05950464","Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer","A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN003694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer","Inclusion Criteria:\n\n* Patients must have pathologically confirmed:\n\n  * PART I: Recurrent clear cell or endometrioid ovarian carcinoma (at least 50% morphology of clear cell and endometrioid required), recurrent clear cell and low grade endometrioid endometrial carcinoma (The International Federation of Gynecology and Obstetrics \\[FIGO\\] grade 1), or recurrent platinum resistant high grade serous ovarian carcinoma\n  * NOTE: platinum-resistant disease is defined as progression within \\\u003C 6 months from completion of platinum-based therapy. The date should be calculated from the last administered dose of platinum therapy\n  * NOTE: Institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian cancer.\n  * NOTE: Patients with recurrent endometrial carcinoma must not be eligible for or decline treatment with curative intent.\n  * PART II: Recurrent clear cell or endometrioid ovarian carcinoma (at least 50% tumor morphology of clear cell and endometrioid required). Recurrent clear cell or FIGO Grade 1 endometrioid endometrial carcinoma. Next Generation Sequencing (NGS) by Clinical Laboratory Improvement Act (CLIA) approved lab required for ARID1A status. Tumor will be determined as ARID1A pathologic alteration or likely pathologic alteration (Cohort I) or ARID1A wildtype by NGS (Cohort II). The number of patients in PART II cohort with clear cell or endometrioid EMCA will be capped at 33% (5 patients per cohort). Institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian cancer.\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of =\\\u003C 2\n* Prior Treatment\n\n  * 1-3 prior cytotoxic therapies\n\n    * NOTE: For platinum-resistant HGSOC (PART 1) may have received up to 3 prior cytotoxic therapies after developing platinum resistant disease.\n  * Subjects with microsatellite instability- high (MSI-H) and\u002For mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor.\n  * Unlimited prior hormonal therapy, targeted therapy (including immunotherapy), and\u002For antiangiogenic therapy will be permitted.\n* Washout periods (due to risk of myelosuppression):\n\n  * Cytotoxic chemotherapy - 3 weeks.\n  * Radiation therapy - 2 weeks (NOTE: patients with radiation to \\> 25% of the bone marrow are NOT eligible).\n* Disease status:\n\n  * For PART I, evaluable disease or measurable disease required. NOTE: evaluable disease: defined as disease related abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions.\n  * For PART II, measurable disease by RECIST 1.1 is required. Patients will be required to undergo biopsy, which may be a non-target lesion but should not be the only RECIST measurable lesion.\n\nNOTE: Patients for PART II are required to undergo paired tumor biopsies. If at time of biopsy the biopsy is deemed unsafe by interventional radiology or attempted and is unsuccessful, patients may still enroll.\n\n* Hemoglobin \\>= 9 g\u002FdL (in the absence of transfusion within 28 days prior to dosing)\n* Absolute neutrophil count \\>= 1,500 cells\u002Fmm\\^3\n* Platelet count \\>= 100,000 cells\u002Fmm\\^3\n* Calculated creatinine clearance (CrCL) of \\>= 50 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level =\\\u003C 3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents should be New York Heart Association (NYHA) Functional Classification of class I or II.\n* The effects of M1774 and ZEN003694 on the developing human fetus are unknown. For this reason and because BETi agents are known to be teratogenic, women of child-bearing potential 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 is participating in this study, she should inform her treating physician immediately. Women of reproductive potential should use effective contraception treatment with M1774 and ZEN003694 and for at least 6 months following the last dose. Women should be advised not to breastfeed while taking M1774 and ZEN003694 and for 1 month after cessation of treatment.\n* Patients 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.\n* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression, are off steroids, and are stable for at least 1 month.\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.\n* PART II only: Participants must have known mutational status (wild-type or pathogenic or likely pathogenic alteration) for ARID1A by Next-Generation Sequencing. This can be determined according to local testing generated by an assay with appropriate regulatory status.\n* Patients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening, or otherwise altering the product formulation.\n* Patients with co-morbidities:\n\n  * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * For patients with evidence of chronic Hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Patients with a history of Hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Resolution of all toxicities of prior therapy or surgical procedures to baseline or grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade =\\\u003C 2), alopecia, and other toxicities considered clinically nonsignificant and\u002For stable on supportive therapy as determined by the investigator).\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents.\n* Patients who have received prior ATR, ATM, CHK, BET, EZH2, and\u002For PI3K inhibitors.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or M1774 used in study.\n* Patients taking proton pump inhibitors given decreased solubility of M1774 with increased pH. Proton pump inhibitors must be discontinued 7 days prior to initiating the trial.\n* Patients with corrected QT (QTc) over 450msec that does not correct with correction of electrolyte abnormalities or family history of long QT syndrome.\n* Patients with severe, active co-morbidity defined as follows:\n\n  * No active infection requiring parenteral antibiotics.\n  * Known hereditary diseases characterized by genetic defects of DNA repair mechanisms, including ataxia telangiectasia, Nijmegen breakage syndrome, Werner syndrome, Bloom Syndrome, Fanconi anemia, xeroderma pigmentosum, Cockayne syndrome, and trichothiodystrophy.\n* Pregnant and breastfeeding women are excluded from this study because ZEN003694 has the potential for teratogenic or abortifacient effects and M1774 is genotoxic in in vivo nonclinical studies. Patients who discontinue breastfeeding are eligible for enrollment and may not resume breastfeeding until 1 month off treatment.\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. Moderate inhibitors of CYP3A4 should be avoided. If alternative is not available, the use of moderate CYP3A4 inhibitors is permitted with careful monitoring and approval by study team. At the discretion of the provider, additional monitoring (labs, toxicity checks) may be implemented for use of moderate CYP3A4 inhibitors. Substrates of CYP1A2 with narrow therapeutic window also must be avoided white taking ZEN003694. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.\n* Patients receiving any medications or substances that are Factor Xa inhibitors are discouraged given concerns for thrombocytopenia (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed. If patients are not willing to switch to low molecular heparin, they must obtain approval by study team.\n* Serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, presence of drainage gastrostomy tube, other chronic gastrointestinal disease, and\u002For other situations that may preclude absorption of oral medications M1774 and\u002For ZEN003694.\n* M1774 restrictions:\n\n  * Patients who cannot discontinue drugs that are strong inhibitors of CYP3A4 or CYP1A2.\n  * Patients who cannot discontinue drugs that use hMATE1 or hMATE2-K substrates.","FEMALE","18 Years",{"count":19,"type":20},65,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase Ib trial tests the safety, side effects, and best dose of M1774 when given with ZEN-3694 in treating patients with ovarian and endometrial cancer that has come back (recurrent). M1774 and ZEN-3694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. M1774 and ZEN-3694 combined together has demonstrated to be better than either drug alone in killing ovarian tumor cells.",[26,27,28,29,30,31,32,33,34],"Recurrent Endometrial Carcinoma","Recurrent Endometrial Clear Cell Adenocarcinoma","Recurrent Endometrial Endometrioid Adenocarcinoma","Recurrent Endometrial Low Grade Endometrioid Adenocarcinoma","Recurrent Ovarian Clear Cell Adenocarcinoma","Recurrent Ovarian Endometrioid Adenocarcinoma","Recurrent Ovarian High Grade Serous Adenocarcinoma","Recurrent Ovarian Low Grade Endometrioid Adenocarcinoma","Recurrent Platinum-Resistant Ovarian Carcinoma","RECRUITING","2026-06-26",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2023-12-18",{"date":43,"type":20},"2027-06-30",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",14,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100457017","phase-2-pembrolizumab-combined-with-bevacizumab-with-or-without-agonist-anti-cd40-cdx-1140-for-the-treatment-of-patients-with-recurrent-ovarian-cancer-100457017","NCT05231122","Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer","Randomized Phase 2 Clinical Trial of Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 in Patients With Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years of age.\n* Recurrent serous (low grade or high grade), endometrioid, or clear cell recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n* Participant can be either platinum-sensitive or platinum-resistant, no more than 4 prior lines of treatment, and BRCA status must be known.\n\nNeoadjuvant + adjuvant is considered one line.\n\n* Participants may have received a prior PARPi, this will not be considered a separate line of therapy if received in maintenance.\n* Participants may have received a prior anti-PD1\u002Fanti-PDL1 therapy or bevacizumab, these will not be considered a separate line of therapy.\n* Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.\n* Hormonal therapy for OC (e.g. Tamoxifen, aromatase inhibitors etc.) will not count as a separate line of prior therapy.\n\n  * Anticipated lifespan greater than 6 months.\n  * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present.\n  * All residual toxicity related to prior anti-cancer therapies (excluding alopecia, grade 2 fatigue, vitiligo, endocrinopathies on stable replacement therapy, grade 2 neuropathy from taxanes or platinum and grade 2 hearing loss from platinum) must be resolved to grade 1 severity or less (or returned to baseline) prior to receipt of study treatment.\n  * Absolute neutrophil count (ANC): \\>= 1,500 \u002FmcL.\n  * Platelets: \\>= 100,000 \u002F mcL.\n  * Hemoglobin: \\>= 8 g\u002FdL or 5.0 mmol\u002FL transfusion allowed with adequate bone marrow function\n  * Creatinine clearance \\>= 50 mL\u002Fmin.\n  * Total bilirubin: =\\\u003C 2 X upper limit of normal (ULN) except patients with Gilbert's syndrome or liver involvement, who must have a total bilirubin =\\\u003C 3 mg\u002FdL.\n  * Aspartate aminotransferase (AST) ( serum glutamic-oxaloacetic transaminase \\[SGOT\\] ) and alanine aminotransferase (ALT) ( serum glutamate pyruvate transaminase \\[SGPT\\]): =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for participants with liver metastases.\n  * Albumin: \\> 2.5 mg\u002FdL.\n  * International normalized ratio (INR) OR prothrombin time (PT) 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  * Participant must be willing to undergo core or excisional biopsy of a tumor lesion within 7 days prior to the first dose of investigational product and after 3 cycles of treatment(prior to cycle 4-day 1: mandatory only if available) and, at the end of treatment (optional). Participants for whom newly obtained samples cannot be provided at baseline (e.g., inaccessible or subject safety concern), may submit an archived specimen, only upon agreement from the Prinicipal Investigator, if available).\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 6 months 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  * Participant (or legal representative) 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* Primary platinum-refractory patients are excluded\n* Has a nonepithelial cancer (germ cell tumors, sex cord-stromal tumors), borderline tumors, mucinous or seromucinous that is predominately mucinous, malignant Brenner's tumor, carcinosarcoma or undifferentiated carcinoma.\n* Receipt of any antibody targeting T cell checkpoint or co-stimulation pathways within 4 weeks, use of any other monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks prior to the planned start of study treatment.\n* Has received prior systemic anticancer therapy (including investigational agents or maintenance therapy) within 28 days prior to the planned start of study treatment.\n\nHormonal therapy is allowed until the time of randomization\n\n* Progression on prior immune checkpoint blockade therapy.\n* Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks prior to the first dose of study treatment.\n* 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 study drug\n* Major surgery within 4 weeks prior to the first dose of study treatment. Surgery requiring local\u002Fepidural anesthesia must be completed at least 72 hours before study drug administration and patients should be recovered.\n* Known or prior malignancy requiring active treatment in the past 2 years. Exception: basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.\n* Active, untreated central nervous system metastases. Patients with brain metastases identified at screening may be rescreened after the lesion(s) have been appropriately treated; patients with treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment, and off corticosteroids for at least 2 weeks before administration of study drugs, and treated lesions should demonstrate no new growth on the re-screening scan.\n* History of (non-infectious) pneumonitis or has current pneumonitis, including grade 1 (asymptomatic; clinical or diagnostic observations only; intervention not indicated) pneumonitis.\n* History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).\n* Prior therapy with any anti-CD40 antibody.\n* Hypersensitivity to bevacizumab, pembrolizumab, or any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months.\n* Has an acute infection requiring systemic therapy\n* Known immunodeficiency or active human immunodeficiency virus (HIV)\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA)and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection\n* Has an active infection requiring systemic therapy\n* Known immunodeficiency or active HIV\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 mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.\n\nInvestigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.\n\n* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n* Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness. Subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility.\n* Subject has a serious, non-healing wound, ulcer, or bone fracture.\n* Subject has a clinically significant cardiovascular disease including:\n\n  * Uncontrolled hypertension \\\u003C 150\u002F90 mmHg (may be rescreened after adequate control)\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* New onset on thromboembolic event or hemorrhage within 6 weeks prior to randomization\n* Subject has organ allografts.\n* Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or require parenteral hydration and\u002For nutrition.\n* Pregnant or nursing female participants.\n* Known active alcohol or drug abuse.\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.",{"count":56,"type":20},80,[58],"PHASE2","This phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolong survival, and improve quality of life in patients with ovarian cancer.",[61,62,63,64,65,66,67,30,31,68,34,69,70,71,72],"Ovarian Clear Cell Adenocarcinoma","Platinum-Sensitive Ovarian Carcinoma","Recurrent Endometrial Serous Adenocarcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Fallopian Tube Endometrioid Adenocarcinoma","Recurrent Fallopian Tube Serous Adenocarcinoma","Recurrent Ovarian Carcinoma","Recurrent Ovarian Serous Adenocarcinoma","Recurrent Primary Peritoneal Carcinoma","Recurrent Primary Peritoneal Clear Cell Adenocarcinoma","Recurrent Primary Peritoneal Endometrioid Adenocarcinoma","Recurrent Primary Peritoneal Serous Adenocarcinoma","2026-05-28",{"date":75,"type":39},"2026-06-01",{"date":77,"type":39},"2024-03-12",{"date":79,"type":20},"2027-03-15",{"name":81,"class":82},"Roswell Park Cancer Institute","OTHER",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100411109","phase-1-testing-the-addition-of-abemaciclib-to-olaparib-for-women-with-recurrent-ovarian-cancer-100411109","NCT04633239","Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer","A Phase 1\u002F1b Dose Escalation Study of Abemaciclib and Olaparib for Recurrent Platinum-Resistant Ovarian Cancer","Inclusion Criteria:\n\n* Patients must have histologically confirmed recurrent platinum-resistant epithelial ovarian carcinoma (EOC) of any histology, as defined by progression within 6 months of the last dose of platinum-based chemotherapy. Both primary platinum resistant and acquired platinum resistant patients are allowed\n* High-grade serous histology is required (for the dose expansion cohort only) (data on BRCA (e.g. germline BRCA, Somatic BRCA, Neither, Unknown) and homologous recombination deficiency (HRD)\u002FLoss of Heterozygosity (LOH) (e.g. HRD \\> 42\u002FLOH \\>16%, HRD score \\\u003C 42\u002FLOH \\\u003C 16%, Unknown) is not required for study but will be collected if available\n* Patients must have received 1-3 prior systemic therapies\n* Women age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of abemaciclib in combination with olaparib in patients \\\u003C18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Hemoglobin \\>= 10 g\u002FdL (within 28 days prior to administration of study treatment)\n\n  * 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* Absolute neutrophil count \\>= 1,500\u002FmcL (within 28 days prior to administration of study treatment)\n* Platelets \\>= 100,000\u002FmcL (within 28 days prior to administration of study treatment)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)\n\n  * Patients with Gilbert's syndrome with a total bilirubin =\\\u003C 2.0 times ULN and direct bilirubin within normal limits are permitted\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN, unless liver metastases are present in which case they must be =\\\u003C 5 x ULN (within 28 days prior to administration of study treatment)\n* Patients must have creatinine clearance estimated of \\>= 51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24-hour urine test (within 28 days prior to administration of study treatment)\n* Glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m\\^2 (within 28 days prior to administration of study treatment). Estimated GFR calculated using Cockcroft-Gault equation\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n\n  * Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\n  * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)\n* Patients with treated brain metastases are eligible if patient is stable for at least 4 weeks status post (s\u002Fp) radiation therapy and off corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\] scan) during the screening period\n* Patients 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, patients should be class 2B or better\n* Postmenopausal or evidence of non-childbearing status, a negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:\n\n  * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\n  * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50\n  * Radiation-induced oophorectomy with last menses \\> 1 year ago\n  * Chemotherapy-induced menopause with \\> 1 year interval since last menses\n  * Surgical sterilization (bilateral oophorectomy or hysterectomy)\n* The effects of abemaciclib and olaparib on the developing human fetus are unknown. For this reason and because CDK-and PARP-inhibiting agents are known to be teratogenic, women of child-bearing potential and their partners, who are sexually active, must agree to the use of one highly effective form of contraception and their partner must use a male condom prior to study entry, for the duration of study participation, and for 6 months after the last dose of study treatment. 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* For the dose expansion cohort, patients must have disease amenable to biopsy for correlative studies, specifically at least 1 tumor accessible and safe for biopsy on office exam or tumor that a radiologist deems is safe for biopsy in interventional radiology department based on imaging (dose expansion cohort only). For the dose escalation cohort, patients with evaluable disease are acceptable\n* For inclusion in i) the optional genetic research and ii) the optional biomarker research, patients must fulfill the following criteria:\n\n  * Provision of informed consent for genetic research prior to collection of sample\n  * Provision of informed consent for biomarker research prior to collection of sample\n  * If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study\n* Patients may not have received prior CDK 4\u002F6 inhibitors. Previous PARP inhibitor use is allowed in front-line treatment but not for recurrent disease\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade =\\\u003C 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy)\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 28 days is required between end of radiotherapy and randomization\n* For agents other than chemotherapy, a 4 week washout period is required. Previous bevacizumab use is allowed\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents\n* History of allergic reaction or hypersensitivity attributed to compounds of similar chemical or biologic composition to abemaciclib, olaparib or any of the excipients of these products\n* Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because abemaciclib is a CDK-inhibiting agent and olaparib is a PARP inhibiting agent with 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 with abemaciclib and olaparib, breastfeeding should be discontinued if the mother is treated with abemaciclib and olaparib\n* Other malignancy unless curatively treated with no evidence of disease for \\>= 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma\n* Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT \\[QTcF\\] prolongation \\> 500 ms, electrolyte disturbances, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest, etc.), or patients with congenital long QT syndrome\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of myelodysplastic syndrome\u002Facute myeloid leukemia (MDS\u002FAML)\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection that, in the judgment of the investigator, would preclude participation in this study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C 30 ml\u002Fmin\\], 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)\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)\n* Patients with an active systemic fungal infection\n* Patients with suspected or history of interstitial lung disease (ILD)\u002Fpneumonitis\n* Patients with active thromboembolism. Active thromboembolism is defined as a diagnosis of a thromboembolic within the last 6 months or continued evidence of thromboembolism on imaging despite stable anti-coagulation for 6 months. Patients with a history of thromboembolism \\> 6 months ago on anti-coagulation as continued prevention are eligible",{"count":92,"type":20},42,[23],"This phase I\u002FIb trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.",[32,34],"2026-05-20",{"date":98,"type":39},"2026-05-22",{"date":100,"type":39},"2021-07-02",{"date":102,"type":20},"2026-11-01",{"name":45,"class":46},27,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":120,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100590176","phase-1-dt2216--paclitaxel-in-platinum-resistant-ovarian-cancer-100590176","NCT06964009","DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer","A Phase 1b Study of BCL-XL Degrader DT2216 in Combination With Weekly Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer","Inclusion Criteria:\n\n* Participants must have histologically confirmed relapsed or refractory ovarian cancer (including epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma).\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* Participants must have received at least one prior platinum-based chemotherapeutic regimen for primary management of disease.\n* Participants must have been treated with at least one line of standard-of-care platinum-based chemotherapy but otherwise there is no limit on lines of prior systemic therapy. For participants who received recent palliative radiotherapy, the radiation treatment must have been completed at least two weeks prior to initiating study treatment. Prior dose-dense paclitaxel as part of initial treatment and prior treatment with weekly paclitaxel in the recurrent setting is permitted; however, at least 6 months must have elapsed between the last dose of weekly paclitaxel and protocol treatment initiation.\n* Age ≥18 years.\n* ECOG performance status 0-2.\n* Participants must meet the following laboratory criteria:\n\n  * absolute neutrophil count ≥1000\u002FmcL\\*\n  * platelets ≥100,000\u002FmcL\\*\n  * hemoglobin ≥8 g\u002FdL\n  * total bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\\*\\*\n  * AST(SGOT)\u002FALT(SGPT) ≤3x institutional ULN\\*\\*\\*\n  * PT\u002FINR ≤ 1.5xinstitutional ULN\n  * Serum albumin ≥ 3.0 g\u002FdL\n  * eGFR (glomerular filtration rate) ≥50 mL\u002Fmin\\*\\*\\*\\*\n\n    * Hematologic criteria must be met in the absence of platelet transfusion within 3 days prior to the screening laboratory measurements. Criteria must also be met without G-CSF products for two weeks and romiplostim for four weeks prior to screening.\n\n      * In patients with Gilbert's disease, total bilirubin should be ≤ 4.0x ULN --\\*\\*\\*In patients with documented hepatic involvement, ≤ 5.0x ULN --\\*\\*\\*\\*Unless patient is receiving anticoagulant therapy and the PT\u002FINR or aPTT is within the intended therapeutic range of the anticoagulant.\n\n        * eGFR should be calculated using the 2021 chronic kidney disease epidemiology (CΚD-EPI) creatinine equation (preferred) or other formula. To convert to units of mL\u002Fmin from units of mL\u002Fminute\u002F1.73 m2, multiply the estimated GFR by the individual's body surface area and divide by 1.73.\n* Participants with known HIV infection should meet the following criteria:\n\n  * CD4+ count ≥ 300\u002FμL.\n  * Undetectable viral load\n  * Receiving highly active antiretroviral therapy\n  * No history of AIDS-defining opportunistic infection in the past 12 months\n* Participants with past Hepatitis B or C infections must have been treated appropriately and have undetectable virus levels in the plasma.\n* 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. Patients with a previously treated malignancy are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease. Patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are allowed to participate.\n* Participants must have platinum-resistant disease, defined by disease progression within 6 months (i.e., 183 days) from their last dose of prior platinum chemotherapy. Disease progression may be defined by imaging or by clinical progression per the assessment of the treating oncologist.\n* Participants must have epithelial ovarian cancer of any histology.\n* The effects of DT2216 on the developing human fetus are unknown. For this reason and because paclitaxel is known to be teratogenic, females of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence from penile-vaginal intercourse) prior to study entry and for the duration of study participation. Participants of childbearing potential who elect to use barrier methods should use a second form of contraception (e.g., cervical cap or diaphragm + male condom, or male condom + vaginal spermicide, etc.) given the failure rates of barrier methods and potential risks to the fetus of the study drugs. 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. Participants of child-bearing potential should agree to continue to use adequate contraception for at least 3 months after the last dose of study drug.\n* The participant or the participant's legal representative must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment with weekly paclitaxel in the recurrent setting. Prior dose-dense paclitaxel as part of the initial treatment at diagnosis is allowed.\n* Prior treatment with any BCL-XL inhibitor, such as navitoclax.\n* Participants who are receiving any other investigational agents for this condition or received an investigational agent within 5 half-lives of the agent or 4 weeks, whichever is shorter.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) except for alopecia. Participants with endocrine- related AEs who are adequately treated with hormone replacement or participants who have grade 2 neuropathy are eligible. Participants with grade 2 anemia likely related to prior treatment are eligible. Participants with a history of a thromboembolic event who are on stable therapeutic anticoagulation are eligible. Participants with asymptomatic grade 2 hypertension controlled with anti-hypertensive medications are eligible.\n* Ongoing treatment with chronic immunosuppressants or systemic steroids \\> 10 mg of prednisone daily (or equivalent). 10 mg daily of oral prednisone or less can be continued if clinically required.\n* Known active central nervous system involvement with metastatic cancer, including leptomeningeal disease. Participants with previously treated brain metastases may enroll if the disease is stable for at least one month on imaging with no neurologic symptoms and participants are not receiving pharmacologic doses of glucocorticoids for this diagnosis.\n* Prior organ transplantation or other cellular therapies such as Chimeric Antigen Receptor T-cells. Prior allogeneic stem cell transplantation (SCT) is allowed if there is no evidence of Graft Versus Host Disease and if participant meets other eligibility criteria listed. Prior autologous SCT is permitted if the participant meets the other eligibility criteria listed.\n* History of major surgery within 8 weeks prior to first dose of study drug.\n* History of clinically significant small or large bowel obstruction within 8 weeks prior to first dose of study drug (e.g. symptomatic, impairing nutrition, requiring nasogastric tube, requiring hospital admission).\n* History of clinically significant ascites or pleural effusion requiring recurrent paracentesis or thoracentesis within 4 weeks prior to first dose of study drug.\n* Dependence upon TPN or regular IV fluid resuscitation.\n* History (≤2 weeks before the start of treatment with the study drug) of ongoing or active infections (Grade ≥ 2).\n* Baseline prolongation of QTc interval (\\> 470 msec) using Bazett's formula or history of Long QT Syndrome. Caution should be exercised with the use of concomitant medications that prolong the QTc interval.\n* History of a bleeding complication within the past 4 weeks, or a clinically significant bleeding predisposition.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, symptomatic angina pectoris, cardiac arrhythmia, on dialysis, on any organ transplant list; any medical condition for which the primary oncologist or principal investigator deems the participant an unsuitable candidate to receive DT2216 and\u002For paclitaxel; or psychiatric illness or other situations that would limit compliance with study requirements.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DT2216 or paclitaxel. Participants with known allergy or hypersensitivity to paclitaxel or to its vehicle formulation may not enroll, except participants who have subsequently tolerated paclitaxel infusions after a hypersensitivity reaction with or without modifications to the pre-medications. If participants develop allergy or hypersensitivity to paclitaxel during treatment on the study, they may be able to remain on study via receiving paclitaxel with a desensitization procedure supervised by an allergy physician after a formal allergy consultation and discussion with the study PI.\n* Participants receiving any medications or substances that are strong inhibitors or inducers of the cytochrome P450 isoenzyme CYP3A4 or CYP2C8 are ineligible. Strong CYP3A4 or CYP2C8 inhibitors and inducers should be discontinued at least 2 weeks prior to the first dose of DT2216. As per paclitaxel product documentation, it is important to use caution with known substrates or inhibitors of the cytochrome P450 isoenzymes CYP3A4 and CYP2C8. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Pregnant females are excluded from this study because the effects of DT2216 on the developing fetus are unknown. Participants must have a negative pregnancy test result at screening (for females of childbearing potential). The test must be performed at the screening and Cycle 1 Day 1 visits. Participants of non-childbearing potential will have had at least continuous 12 months of natural (spontaneous) amenorrhea, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms), or have had surgical bilateral oophorectomy, hysterectomy, or have had bilateral tubal ligation \\>6 weeks prior to screening. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with DT2216, breastfeeding should be discontinued if the mother is treated with DT2216. These potential risks may also apply to other agents used in this study; specifically, paclitaxel has known embryo- and fetotoxicity.",{"count":113,"type":20},30,[23],"The purpose of this research study is determining the highest dose of the study drug DT2216 in combination with paclitaxel that can be safely and tolerably administered in recurrent ovarian cancer.\n\nThe names of the study drugs involved in this study are:\n\n* DT2216 (a type of proteolysis-targeting chimera degrader of BCL-XL protein)\n* Paclitaxel (a type of antimicrotubule agent)",[117,118,119,34],"Ovarian Cancer","Ovarian Carcinoma","Recurrent Ovary Cancer",[117,118,119,121,34,122],"Recurrent Ovarian Cancer","Recurrent Platinum-Resistant Ovarian Cancer","2026-04-20",{"date":125,"type":39},"2026-04-21",{"date":127,"type":39},"2025-09-22",{"date":129,"type":20},"2027-12-30",{"name":131,"class":82},"Elizabeth Stover, MD, PhD",3,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100553204","phase-1-muc1-activated-t-cells-for-the-treatment-of-relapsed-and-resistant-ovarian-cancer-100553204","NCT06483048","MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer","Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer\n* PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET\u002FCT\n\n  * Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler\n* PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1\u002F2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring \\\u003C 183 days after the last dose of platinum-based chemotherapy:\n\n  * Development of measurable disease (per RECIST 1.1)\n  * Progression of radiographic disease (per RECIST 1.1)\n  * Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits \\[WNL\\] at the completion of platinum-based chemotherapy)\n  * Increase in CA-125 level to ≥ 2 x nadir (if nadir \\> ULN)\n  * If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval\n* PRE-REGISTRATION: Provide written informed consent\n* PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma\n* REGISTRATION: MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study\n* REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months\n* REGISTRATION: Willingness and ability to provide written informed consent\n* REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study\n* REGISTRATION: Willing to undergo leukapheresis for blood component collection\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Lymphocyte count ≥ 1500\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Hemoglobin ≥ 8.0 g\u002FdL (performed ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 30,000\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 2.0 mg\u002FdL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis \\[DVT\\]\u002Fpulmonary embolism \\[PE\\] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)\n* REGISTRATION: Baseline oxygen saturation ≥ 90% on room air\n* REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration\n\nExclusion Criteria:\n\n* Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for \\> 30 days, and not requiring steroid therapy for \\> 14 days\n* Prior treatment targeting MUC1\n* Subjects with known plasma cell leukemia (PCL)\n* Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and\u002For teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate birth control measures\n* History of myocardial infarction ≤ 6 months prior to registration, and\u002For congestive heart failure requiring ongoing treatment such as medications and\u002For an implanted defibrillator to control life-threatening arrhythmias\n* Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.\n* Uncontrolled concurrent illness including, but not limited to:\n\n  * Inability to clear an ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Uncontrolled psychiatric problems\n  * Inability to have a caregiver for active oversight during treatment period\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements\n* Evidence of clinical immunocompromise and\u002For HIV positivity and currently receiving antiretroviral therapy\n* Patients requiring chronic supraphysiologic daily doses of steroids (\\> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)\n* Patients receiving any other investigational agent which could be considered a treatment for the neoplasm\n* Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence\n* Diagnosis of autoimmune disease\n\n  * Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded",{"count":141,"type":20},12,[23],"This phase I trial tests the safety, side effects, best dose of MUC1-activated T cells in treating patients with ovarian cancer that has come back after a period of improvement (relapsed) or that remains despite treatment (resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and are made in a laboratory to recognize MUC1, a protein on the surface of tumor cells that plays a key role in tumor cell growth. These MUC1-activated T cells may help the body's immune system identify and kill MUC1 expressing ovarian tumor cells.",[145,146,147,64,148,149,67,150,151,34,69,152,153,154,155,156],"Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Ovarian Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","Recurrent Fallopian Tube Carcinosarcoma","Recurrent Female Reproductive System Carcinoma","Recurrent Ovarian Carcinosarcoma","Recurrent Platinum-Resistant Fallopian Tube Carcinoma","Recurrent Primary Peritoneal Carcinosarcoma","Refractory Fallopian Tube Carcinoma","Refractory Female Reproductive System Carcinoma","Refractory Ovarian Carcinoma","Refractory Primary Peritoneal Carcinoma","2026-03-13",{"date":159,"type":39},"2026-03-16",{"date":161,"type":39},"2024-09-20",{"date":163,"type":20},"2028-09-30",{"name":165,"class":82},"Mayo Clinic",1]