[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clear-cell-adenocarcinoma-of-ovary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clear-cell-adenocarcinoma-of-ovary":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100572213","phase-2-a-study-of-lorigerlimab-in-participants-with-advanced-solid-tumors-100572213",false,"NCT06730347","A Study of Lorigerlimab in Participants With Advanced Solid Tumors","A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR\n* Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.\n* Persistent or recurrent disease with documented disease progression.\n* Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.\n* Participants with CCGC must have received at least 1 prior line of therapy for CCGC.\n* Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or intolerance on the PARP inhibitor.\n* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.\n* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.\n* Participants have acceptable physical condition and laboratory values.\n* Participants of childbearing potential must agree to use highly effective methods of birth control.\n* Participants must not be pregnant, planning to be pregnant, or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.\n* Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1\u002FPD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial and clear cell cervical cancer.\n* Active brain metastases or leptomeningeal metastases.\n* Prior stem cell, tissue, or solid organ transplant.\n* Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.\n* Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.","FEMALE","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC.\n\nParticipants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends.\n\nParticipants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.",[26,27,28,29,30,31,32,33,34,35,36],"Platinum-resistant Ovarian Cancer","Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","Clear Cell Adenocarcinoma of Ovary","Clear Cell Adenocarcinoma of Vulva","Clear Cell Adenocarcinoma of Vagina","Clear Cell Adenocarcinoma of Cervix","Clear Cell Adenocarcinoma of Uterus","Clear Cell Adenocarcinoma of Fallopian Tube","Clear Cell Adenocarcinoma of Peritoneum","Endometrial Cancer","RECRUITING","2026-05-29",{"date":40,"type":41},"2026-06-02","ACTUAL",{"date":43,"type":41},"2025-05-01",{"date":45,"type":20},"2027-12",{"name":47,"class":48},"MacroGenics","INDUSTRY",16,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100605865","efficacy-and-safety-of-sacituzumab-in-patients-with-occc-after-immunotherapy-progression-100605865","NCT07168083","Efficacy and Safety of Sacituzumab in Patients With OCCC After Immunotherapy Progression","The Efficacy and Safety of Sacituzumab in Patients With Ovarian Clear Cell Carcinoma After the Progression of Immunotherapy: A Prospective Real-world Study","Inclusion Criteria:\n\n* Histologically diagnosed ovarian clear cell carcinoma\n* Patients who have progressed on imaging assessment after receiving immunotherapy, including anti-PD-1, PD-L1, and PD-1\u002FPD-L1+CTLA4, and subsequently received Sacituzumab.\n* At least one measurable lesion as assessed by RECIST, version 1.1.\n* Life expectancy ≥ 12 months.\n* Normal renal an liver function, no myelosuppression.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score (PS score) 0-1.\n* Participants must have recovered from all toxicities resulting from previous treatment (recovery to \\\u003C grade 1 or protocol-specified inclusion criteria, based on a CTCAE 5.0 assessment), excluding alopecia.\n* Participants must be willing to participate in the study, be compliant, sign the informed consent form, and be able to adhere to protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n* Receipt of more than two lines of therapy after progression on immunotherapy.\n* Previous use of irinotecan or ADCs containing topoisomerase I inhibitors.\n* Presence or history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment\n* Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or a history of corneal disease that prevents delayed corneal healing.\n* Concomitant incomplete or complete intestinal obstruction, intestinal fistula of any grade, hydronephrosis that cannot be resolved with a ureteral stent, inflammatory bowel disease or brain metastases.\n* Organ transplant recipient.\n* ≥ Grade 3 venous embolism\n* Active infectious disease of any grade, including tuberculosis.\n* Previous history of pelvic or abdominal radiation therapy to any site.\n* Concurrent with other types of malignant tumors.\n* Mental status abnormalities.\n* Pregnant or lactating women; or patients of childbearing potential (male or female) who are unable to use effective medical contraception during the study period and for 6 months after the end of dosing.\n* Any other condition deemed inappropriate for participation in this study by the investigator.","70 Years",{"count":59,"type":20},22,"2 Years","OBSERVATIONAL","Ovarian clear cell carcinoma (OCCC) is a relatively rare but highly malignant epithelial ovarian cancer, accounting for 5%-10% of all ovarian cancers. The incidence of this tumor has significant racial disparity, with the highest incidence in Asians, accounting for 25% of ovarian cancer patients, while in European and American ovarian cancer patients, it only accounts for 4.8%. Due to the unique biological behavior of OCCC, it responds poorly to traditional platinum-based chemotherapy regimens, and the prognosis of patients with advanced and recurrent disease is extremely poor.\n\nOCCC has low sensitivity to platinum-based chemotherapy, especially in recurrent or persistent disease, and the objective response rate (ORR) of chemotherapy is usually less than 10%. Although immunotherapy has shown good results in OCCC, 60% of patients still cannot shrink their tumors after using combination regimens, and 50% of patients will still progress after 6.9 months of treatment. The question of how to treat OCCC after progression on immunotherapy remains a pressing issue. Sacituzumab (SKB264) is an antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen 2 (Trop-2) monoclonal antibody conjugated to T030. In the KL264-I-01 study (which included patients with OCCC) in patients with recurrent ovarian cancer, single-agent Sacituzumab achieved an objective response rate of 40%, superior to conventional chemotherapy, with manageable toxicity. OCCC patients who progress on immunotherapy face a dilemma of limited treatment options. Based on this current situation and the potential activity of Sacituzumab the investigators propose Sacituzumab as an option for patients with OCCC after immunotherapy progression.",[64,65,29],"Ovarian Cancer","Antibody-drug Conjugates",[67,68],"Ovarian Clear Cell Carcinoma","antibody-drug conjugate","NOT_YET_RECRUITING","2025-09-10",{"date":72,"type":41},"2025-09-11",{"date":74,"type":20},"2026-09-01",{"date":76,"type":20},"2029-08-31",{"name":78,"class":79},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER"]