[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-ovary-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-ovary-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100540795","phase-1-intraperitoneal-cytokine-induced-memory-like-ciml-natural-killer-nk-cells-in-recurrent-ovarian-cancer-100540795",false,"NCT06321484","Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer","A Phase 1b Study of Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cell Therapy in Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed recurrent epithelial ovarian cancer. Eligible histologies include high grade serous, high grade endometrioid and clear cell ovarian carcinoma.\n* Participants must have measurable cancer defined by RECIST 1.1 criteria.\n* Patients must have received at least 1 lines of prior systemic therapy and be deemed platinum resistant\u002Fintolerant by their treating oncologist. Patients with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment. Prior receipt of immune checkpoint blockade is allowed if grade 3 or higher toxicities were not experienced.\n* Age ≥18 years and \\\u003C85 years old.\n* ECOG performance status of 0 or 1.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1,000\u002FmcL\n  * Platelets ≥75,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤3 x institutional ULN\n  * Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * Serum creatinine ≤ 2.0 mg\u002FdL OR glomerular filtration rate (GFR) ≥40 mL\u002Fmin\u002F1.73 m2\n  * Oxygen saturation: ≥ 90% on room air\n  * Left ventricular ejection fraction (cardiac function) ≥ 40%\n  * No laboratory evidence of ongoing hemolysis in opinion of investigator\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.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Physician assessment indicating the patient would be able to tolerate undergoing a brief procedure for placement of an intraperitoneal port for NK cell infusion.\n* Ability to understand and the willingness to sign a written informed consent document.\n* The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason and because CIML NK cells and IL-2 may be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n\nExclusion Criteria:\n\n* Participants who have had anti-tumor chemotherapy or other investigational agents within two weeks prior to NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 6 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior.\n* Participants with a bowel obstruction within the last 3 months or high risk for bowel obstruction (in the opinion of the investigator) or current need for parenteral nutrition or dependence on intravenous fluids.\n* Participants who are receiving any other investigational agents.\n* Solid organ transplant (allograft) recipients.\n* Participants with known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy, or cancers from which the patient has been disease-free for \\> 1 year after treatment with curative intent.\n* History of severe or anaphylactic allergic reactions attributed to compounds of similar chemical or biologic composition to CIML NK cells or IL-2 or any of the other agents used in study.\n* For patients with prior exposure to check point inhibitor therapy, those with a prior history of immune-related toxicity during immune therapy that resulted in permanent discontinuation of therapy (as recommended per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well-controlled on replacement hormones) are excluded.\n* Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[Wegener's granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g., GuillainBarre syndrome and myasthenia gravis). Patients with Hashimoto thyroiditis are eligible.\n* Systemic corticosteroid therapy (\\> 10 mg of prednisone or equivalent dose of systemic steroids for at least 4 weeks prior to NK cell infusion).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by fludarabine\u002Fcyclophosphamide chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n* HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high-risk of lethal treatment-related hepatotoxicity in the setting of marrow suppression. Known non-infectious pneumonitis or any history of interstitial lung disease.\n* Receipt of a live vaccine within 30 days of start of study treatment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.\n* Anaphylactic reactions to murine-based antibody therapy or iron dextran as the CIML NK cell product contains similar reagents at end of manufacturing\u002Finfusion.\n* Prior history of Grade 2 or higher hemolytic anemia (\\>\u002F= 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.","ALL","18 Years","85 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy in recurrent, high grade ovarian cancer (HGOC).\n\nNames of the study therapies involved in this study are:\n\nCIML NK (cellular therapy) Interleukin-2 (IL-2)",[27,28,29,30,31,32,33],"Platinum-resistant Ovarian Cancer","Recurrent Ovary Cancer","Ovarian Cancer","Ovarian Carcinoma","Ovarian Carcinoma, Recurrent","Endometroid Ovarian Carcinoma","Clear Cell Ovarian Carcinoma",[35,28,29,30,31,32,33],"Platinum-Resistant Ovarian Cancer","RECRUITING","2026-06-15",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":40},"2024-10-09",{"date":44,"type":21},"2031-10-31",{"name":46,"class":47},"Dana-Farber Cancer Institute","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"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.","FEMALE",{"count":57,"type":21},30,[24],"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)",[29,30,28,61],"Recurrent Platinum-Resistant Ovarian Carcinoma",[29,30,28,63,61,64],"Recurrent Ovarian Cancer","Recurrent Platinum-Resistant Ovarian Cancer","2026-04-20",{"date":67,"type":40},"2026-04-21",{"date":69,"type":40},"2025-09-22",{"date":71,"type":21},"2027-12-30",{"name":73,"class":47},"Elizabeth Stover, MD, PhD",3]