[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07718854":3,"trial-entities:NCT07718854":107,"trial-summary:NCT07718854":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":44,"secondary_outcomes":49,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":81,"locations":84,"central_contacts":102,"overall_officials":104,"references":105,"see_also_links":106},"NCT07718854","Sacituzumab-OCCC","Sacituzumab Tirumotecan +\u002F- Pembrolizumab in I\u002FO Exposed Metastatic or Recurrent Ovarian Clear Cell Cancer","A Phase 2 Randomized Trial of Sacituzumab Tirumotecan (MK2870) Alone and in Combination With Pembrolizumab in Ovarian Clear Cell Carcinoma Previously Exposed to Immunotherapy","NOT_YET_RECRUITING","2032-03","2026-07","2026-07-22","2026-06","Tufts Medical Center","OTHER",true,"This is a phase II randomized study of Sacituzumab tirumotecan, an intravenous antibody-drug conjugate (ADC) that targets Trop-1, administered alone or in combination with pembrolizumab, a monoclonal antibody to PD-1 in patients with relapsed clear cell cancers that originated in the ovary, fallopian tube or peritoneal cavity, inclusive of endometriosis (collectively referred to as OCCC throughout the protocol) after previous treatment with anti-PD1 therapy.","The treatment plan consists of Sacituzumab tirumotecan administered at 4 mg\u002Fkg on days 1, 15, and 29 as a single agent (Arm 1) or in combination with pembrolizumab 400mg on day 1 (Arm 2). Each cycle will be 42 days. Treatment is administered for a maximum duration of two years on both arms. The interventions are summarized in Table 1.",[19,20,21],"Ovarian Clear Cell Carcinoma","Metastatic Ovarian Cancer","Recurrent Ovarian Clear Cell Adenocarcinoma",[23,24,25,26,27],"clear cell carcinoma","ovarian","Sacituzumab","MK2870","pembrolizumab","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},50,"ESTIMATED",[36,41],{"type":37,"name":38,"description":38,"armGroupLabels":39},"DRUG","Sacituzumab tirumotecan",[38,40],"Sacituzumab tirumotecan + Pembrolizumab",{"type":37,"name":42,"description":27,"armGroupLabels":43},"Pembrolizumab",[40],[45],{"measure":46,"description":47,"timeFrame":48},"Overall Response Rate (ORR).","Responses will be confirmed by serial imaging (CT or MRI), conducted at least 4 weeks apart. Initial tumor scans at Screening must be performed within 28 days before randomization. The first on-study scan should be performed 6 weeks (42 days+7 days) from the date of randomization. Subsequent tumor scans should be performed every 12 weeks (84 days±7 days) or more frequently if clinically indicated for the first two years of treatment (Week 104). After Week 104 (±7 days), tumor scans should be performed every 16 weeks (112 days±7 days) until documentation of disease progression.\n\nScans are to be performed until disease progression is identified by the investigator or until any of these conditions are met:\n\n* start of a new anticancer therapy\n* pregnancy\n* death\n* withdrawal of consent\n* the end of the study","First scan collected within 28 days prior to randomization, then according to the schedule above until disease progression, new anticancer therapy, pregnancy, death, withdrawal of consent, or the end of the study, whichever occurs first, up to ten years.",[50,54,58,60],{"measure":51,"description":52,"timeFrame":53},"Clinical benefit rate (Response+Stable disease at 6 months)","Responses will be confirmed by serial imaging (CT or MRI), conducted at least 4 weeks apart. Initial tumor scans at Screening must be performed within 28 days before randomization. The first on-study scan should be performed 6 weeks (42 days+7 days) from the date of randomization. Subsequent tumor scans should be performed every 12 weeks (84 days±7 days) or more frequently if clinically indicated for the first two years of treatment (Week 104). After Week 104 (±7 days), tumor scans should be performed every 16 weeks (112 days±7 days) until documentation of disease progression. Scans are to be performed until disease progression is identified by the investigator or until any of these conditions are met: • start of a new anticancer therapy • pregnancy • death • withdrawal of consent • the end of the study","Baseline imaging assessment will be collected within 28 days before randomization. All scans obtained thereafter through the first six months after randomization.",{"measure":55,"description":56,"timeFrame":57},"Toxicity of Treatment (Adverse Events)","* All AEs from the time of intervention randomization through 90 days after cessation of study intervention must be reported by the investigator.\n* All AEs meeting serious criteria, from the time of intervention randomization through 90 days after cessation of study intervention must be reported by the investigator.\n* All pregnancies and exposure during breastfeeding, from the time of intervention randomization through the time required to eliminate systemic exposure after cessation of study intervention, or 90 days after cessation of study intervention if the participant initiates new anticancer therapy must be reported by the investigator.\n* Additionally, any SAE brought to the attention of an investigator at any time outside the time specified above must be reported immediately to the Sponsor\u002FPrincipal Investigator if the event is considered related to study intervention.","Safety information will be collected according to protocol guidellines from the time of patient signing of informed consent through 90 days after cessation of study intervention or until resolution.",{"measure":59,"description":47,"timeFrame":48},"Progression-Free Survival (Time to progression of disease)",{"measure":61,"description":62,"timeFrame":63},"Overall Survival (Time to Death)","Participant survival follow-up status will be assessed approximately every 12 weeks to assess for survival status until death, withdrawal of consent, or the end of the study, whichever occurs first.\n\nThe first survival follow-up assessment should be scheduled as described below:\n\n* For participants who discontinue treatment intervention and who will not enter Efficacy Follow-up, the first survival follow-up contact will be scheduled 12 weeks after the Discontinuation Visit and\u002For Safety Follow-up Visit (whichever is last).\n* For participants who completed assessments in Efficacy Follow-up, the first survival follow-up contact will be scheduled 12 weeks after the last efficacy assessment follow-up visit has been performed.","Survival status will be assessed beginning after the discontinuation, safety follow-up or final efficacy follow-up visit, approximately every 12 weeks until death, withdrawal of consent, or the end of the study, whichever occurs first, up to 10 years.","FEMALE","18 Years",null,false,{"inclusion":69,"exclusion":79,"raw_text":80},[70,71,72,73,74,75,76,77,78],"Is not a Person of Child-Bearing Potential (POCBP) OR","Is a POCBP and:","Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.5.","Abstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.","Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.","There is a known history of HBV infection","Mandated by local guidelines 16. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.","There is a known history of HCV infection","Mandated by local guidelines",[],"Inclusion Criteria:\n\nType of Participant and Disease Characteristics\n\n1. Has a histologically-confirmed diagnosis of pure OCCC. Patients with mixed histologies that include a clear cell component will not be eligible for this trial.\n2. Has measurable disease per RECIST 1.1 as assessed by the local site investigator\u002F radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.\n3. Patients must have received at least one prior platinum and taxane based chemotherapy regimen. Radiation therapy (including the use of chemotherapy as a radiosensitizer) will not count as a prior systemic regimen.\n4. Patients must have also received one prior line containing an immune checkpoint inhibitor (ICI) More than one prior line of ICI treatment will be exclusionary.\n5. Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n6. ECOG performance status 0-1\n7. Is an individual of assigned female sex at birth and is at least 18 years of age at the time of providing the informed consent.\n8. Participant is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a Person of Child-Bearing Potential (POCBP) OR\n   * Is a POCBP and:\n\n     \\- Agrees to use of a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The participant agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during this period for the purpose of reproduction. The length of time required to continue contraception for Sacituzumab tirumotecan is 210 days.\n\n     ◦ sacituzumab tirumotecan: 210 days\n\n     \\- The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n     * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.5.\n     * Abstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.\n     * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.\n\nInformed Consent 8. The participant (or legally acceptable representative if applicable) provides written informed consent for the study.\n\nAdditional Categories 9. Has provided an archival tumor tissue sample (slides or block) for pathologic confirmation of diagnosis at Tufts Medical Center.\n\n10\\. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n\n11\\. Adequate organ function as defined in the following table (Table 3). Specimens must be collected within 10 days before the start of study intervention.\n\n12\\. Any other medical condition that will prevent the safe administration of study drugs in the opinion of the treating physician.\n\n13\\. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.\n\n14\\. HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n1. Having a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n2. Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening.\n3. Absence of any AIDS-defining opportunistic infections within the past 12 months\n4. Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before randomization and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers\u002Finhibitors\u002Fsubstrates. Refer to https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor\u002Fsubstrate of CYP3A4.\n\nHIV testing at screening is not otherwise required. 15. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization.\n\nNote: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\nHepatitis B testing at screening is not required unless:\n\n* There is a known history of HBV infection\n* Mandated by local guidelines 16. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before randomization.\n\nHepatitis C testing at screening is not required unless:\n\n* There is a known history of HCV infection\n* Mandated by local guidelines\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n2. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.\n3. 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.\n4. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n5. History of stem cell\u002Fsolid organ transplant. Prior\u002FConcomitant Therapy\n6. Received prior treatment with a TROP2-targeted ADC.\n7. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.\n8. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.\n9. Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and\u002For has radiation pneumonitis.\n\n   Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n10. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n    Refer to Section 6.2 for information on COVID-19 vaccines.\n11. Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n\n    Note: A list of strong inducers\u002Finhibitors of CYP3A4 can be found at the following website: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor of CYP3A4.\n\n    Prior\u002FConcurrent Clinical Study Experience\n12. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.\n13. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n\n    Diagnostic Assessments\n14. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of any organ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n\n    Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n15. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously-treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n16. Has an active infection requiring systemic therapy.\n17. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n\n    Other Exclusions\n18. Severe hypersensitivity (Grades ≥3) to study interventions, any of their excipients, and\u002For to another biologic therapy.\n19. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n\n    Note: Participants who underwent major surgery must have adequately recovered from toxicity and\u002For complications from the surgery before starting study intervention.\n20. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n21. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":99},"Boston","Massachusetts","02111","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Neely Center for Clinical Cancer Research","CONTACT","617-636-5000","TMNCCCR@tuftsmedicine.org",{"name":97,"role":98},"Don S Dizon, MD","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},42.35843,-71.05977,[103],{"name":92,"role":93,"phone":94,"email":95},[],[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Ovarian Clear Cell Adenocarcinoma",[111],"Programmed Cell Death Protein 1",{"nct_id":4,"found":15,"summary":113,"prompt_version":123},{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is a randomized study, meaning participants will be assigned by chance to receive either Sacituzumab tirumotecan alone or Sacituzumab tirumotecan with pembrolizumab. It plans to enroll 50 participants.","completed","Study of Sacituzumab Tirumotecan with or without Pembrolizumab for Ovarian Clear Cell Cancer","This study is for women aged 18 and older with ovarian clear cell cancer that has spread (metastatic) or come back (recurrent), and who have already received anti-PD1 therapy. It tests Sacituzumab tirumotecan, a drug that targets cancer cells, either alone or combined with pembrolizumab, a drug that helps your immune system fight cancer. The study aims to see how many patients respond to these treatments (Overall Response Rate). You must have a confirmed diagnosis of pure ovarian clear cell cancer and measurable disease to join. The study is currently recruiting 50 participants.","Your progress will be monitored until your disease gets worse, you start new cancer treatment, become pregnant, pass away, withdraw from the study, or the study ends, for up to ten years.",93,"Treatment involves Sacituzumab tirumotecan given on days 1, 15, and 29, and pembrolizumab (if in that arm) on day 1, every 42 days. Treatment can last up to two years, and scans will be done regularly to check for changes.","Not stated in the trial record.",[38,42],"v2"]