[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AGO Research GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100508700","phase-2-pembrolizumab-combination-with-lenvatinib-in-pts-with-recurrentpersistentmetastatic-or-locally-advanced-vulvar-cancer-not-amenable-to-curative-surgery-or-radiotherapy-100508700",false,"NCT05903833","Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy","Pembrolizumab in Combination With Lenvatinib in Pts With Recurrent, Persistent, Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy","PIERCE","Inclusion Criteria:\n\n1. Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements.\n2. Female patients who are at least 18 years of age on the day signing informed consent\n3. Histologically confirmed locally advanced, recurrent, persistent and\u002For metastatic VSCC not amenable for salvage surgery or definitive (chemo)radiation (additive palliative radiotherapy for symptom control is allowed)\n4. ≤2 previous lines of chemotherapy for recurrent or metastatic disease\n5. Measurable disease (investigator assessed RECIST 1.1). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n6. Have an eastern cooperative oncology group (ECOG) performance status of 0-1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n7. No pregnancy (as documented by a positive beta-human chorionic gonadotropin \\[ß-hCG\\] or human chorionic gonadotropin \\[hCG\\]) test with a minimum sensitivity of 25 IU\u002FL or equivalent units of ß-hCG \\[or hCG\\]), no breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n   2. A WOCBP who agrees to follow the contraception and pregnancy testing recommendations for investigational medicinal products (IMPs) with demonstrated or suspected human teratogenicity\u002F fetotoxicity in early pregnancy of the CTFG-guideline in Appendix 3 during the treatment period and for at least 4 months (corresponding to time needed to eliminate pembrolizumab) after the last dose of study treatment. In addition to the described highly effective oral\u002Ftransdermal contraception methods a barrier method must be used.\n\n   A WOCBP should not become pregnant during the treatment and for at least 4 months.\n8. Available archival tumor tissue sample and\u002For newly obtained core or excisional biopsy of a tumor lesion ideally not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n9. Adequate organ function as defined in Table 3 of study protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n1. Non squamous cell histology\n2. Contraindications regarding treatment with pembrolizumab:\n\n   allergy or hypersensitivity to pembrolizumab or one of the components.\n3. Contraindications regarding treatment with lenvatinib: allergy or hypersensitivity to lenvatinib or one of the components or:\n\n   1. Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula\n   2. Radiographic evidence of major blood vessel infiltration\n4. Bradyarrhythmia\n5. Arterial dissection\u002Faneurysm\n6. Long QT Syndrome\n7. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 12 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening.\n8. History or evidence of major thrombotic (e.g. symptomatic pulmonary embolism) or hemorrhagic disorders within 6 months prior to day 1, cycle 1. The degree of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n9. Allogenic tissue\u002Fsolid organ transplant.\n10. Diagnosis of immunodeficiency\n11. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years (time requirement does not apply for definitively treated early endometrial cancer (FIGO IA\u002FB), in-situ carcinomas \\[e.g. breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin).\n13. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n14. Active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n15. History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n16. Major active infection requiring systematic therapy.\n17. Has active hemoptysis within 3 weeks prior to the first dose of study intervention or tumor bleeding within 2 weeks prior randomization.\n18. Known history of Human Immunodeficiency Virus (HIV) infection\n19. History of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n20. Known history of active TB (Bacillus tuberculosis).\n21. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n22. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n23. Pregnancy\n24. Breastfeeding Prior\u002F Concomitant Therapy\n25. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n26. Systemic use of corticosteroids or immunosuppressive drugs within 7 days prior start of study treatment (see EC 11.)\n\n    * Systemic corticosteroids (at dose higher than 10 mg\u002Fday equivalent prednisone); if systemic corticoid use, corticoid must be stopped at least 7 days before study treatment start\n    * Interferons\n    * Interleukins\n    * Live vaccine\n\n    Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed as other killed vaccines, if done at least 2 weeks prior the first dose of study drug; however, intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.\n27. Antiarrhythmics of classes Ia and III and other QT-interval prolongation drugs\n28. Prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to allocation.\n29. Prior radiotherapy within 2 weeks of start of study intervention. Patients must have recovered from radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n30. Not recovered adequately from any toxicity from other anticancer treatment regimens and\u002For complications from major surgery prior to starting therapy. Note: Withhold lenvatinib for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing.\n31. Administration of a live, attenuated vaccine within 30 days prior first dose of study drug. Diagnostic Assessments\n32. Uncontrolled blood pressure (Systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg) in spite of an optimized regimen of antihypertensive medication.\n33. Change of anti-HTN (hypertension) medical regimen within 1 week prior to randomization\n34. Prolongation of corrected QT interval (QTc interval) \\>480 ms\n35. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n36. Electrolyte abnormalities that have not been corrected.\n37. Subjects having \\>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours. Prior\u002FConcurrent Study Experience\n38. Prior enrolment on a clinical study evaluating pembrolizumab and lenvatinib for a carcinoma, regardless of treatment received.\n39. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Note: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.","FEMALE","18 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.",[27,28,29,30],"Recurrent Vulvar Cancer","Persistent Vulvar Cancer","Metastatic Vulva Cancer","Locally Advanced Vulvar Cancer",[32,33,34,35,36,37,38],"Advanced vulvar cancer","Recurrent vulvar cancer","Persistent vulvar canser","Metastatic vulvar cancer","Locally advanced vulvar cancer","Pembrolizumab","Lenvatinib","RECRUITING","2026-05-06",{"date":42,"type":43},"2026-05-11","ACTUAL",{"date":45,"type":43},"2025-06-24",{"date":47,"type":21},"2029-10-30",{"name":49,"class":50},"AGO Research GmbH","INDUSTRY",15,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100411956","phase-2-woo-window-of-opportunity-trial-of-olaparib-and-durvalumab-in-histologically-proven-eoc-100411956","NCT04644289","WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC","Window-of-opportunity Proof-of-concept, Non-randomized, Open-label Phase II Trial of Olaparib Given Alone (Cohort A) or in Combination With Durvalumab (Cohort B) Prior to Primary Debulking Surgery in Histologically Proven High-grade Epithelial Ovarian Cancer (EOC)","WoO","Inclusion Criteria:\n\nWoO pre-treatment (screening phase):\n\n1. Patients with presumed and previously untreated advanced stage ovarian cancer planned to undergo laparoscopy for histologic diagnosis and treatment planning\n2. Patients willing and able to comply with the study protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n3. Patients able and willing to provide fresh frozen biopsy samples from laparoscopy as well as primary debulking for translational endpoints as well as serial liquid biopsies\n4. Patients able and willing to provide formaldehyde-fixed paraffin embedded (FFPE) tissue samples from laparoscopy and primary debulking surgery\n5. Patients aged ≥18 years\n6. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n7. Provision of signed and dated, written ICF for the mandatory biomarker and genetic re-search as well as the clinical\u002Ftherapeutic part of the study prior to any mandatory study specific procedures, sampling, and analyses\n8. Eastern cooperative oncology group (ECOG) performance status 0-1 (see Appendix 1)\n9. Patients must have a life expectancy ≥16 weeks\n10. Ability to take oral medication\n11. Postmenopausal or evidence of non-childbearing status for women of childbearing potential (WOCBP): negative serum pregnancy test within 28 days of study treatment and confirmed neagtive urine or serum pregnancy test prior to treatment on day 1.\n\n    Postmenopausal is defined as:\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 post menopausal 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 sterilisation (bilateral oophorectomy or hysterectomy)\n12. Women of childbearing potential (WOCBP) and their partners, who are sexually active, must agree to the use of 2 highly effective forms of contraception in combination. This should be started from the signing of the informed consent and continue throughout the period of taking study treatment and for at least 6 months after last dose of study drug(s), or they must totally\u002Ftruly abstain from any form of sexual intercourse.\n\n    WoO treatment phase:\n13. Confirmed advanced (FIGO IIB\u002FIII\u002FIV) high-grade, non-mucinous, non-clear cell epithelial ovarian, fallopian tube or primary peritoneal cancer or known (BReast CAncer) BRCA mutation and any histologic type\n14. Planned primary debulking surgery after confirmation of diagnosis and disease evaluation during laparoscopy\n15. Body weight \\>30kg\n16. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\n\n    * Haemoglobin ≥10.0 g\u002FdL with no blood transfusion in the past 28 days\n    * Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL\n    * Platelet count ≥100×10\\^9\u002FL\n    * Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST), serum glutamic oxaloacetic transaminase (SGOT) \u002F alanine aminotransferase (ALT), serum glutamic pyruvate transaminase (SGPT) ≤2.5 × institutional upper limit of normal unless liver metastases are present in which case they must be ≤5×ULN. (cave: patients with intrahepatic metastases affecting liver function test might not be candidates for primary debulking surgery)\n    * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test:\n\nEstimated creatinine clearance=((140-age \\[years\\])\\*weight (kg))\u002F(serum creatinine (mg\u002FdL)\\*72)(\\* 0,85) 17. Patients must have successfully contributed blood and tissue samples as per requirements.\n\nExclusion Criteria:\n\nMedical conditions:\n\n1. Disease requiring urgent surgical intervention\n2. Evidence of significant uncontrolled concomitant disease that could affect compliance with the study protocol\n3. Significant uncontrolled symptom burden (e.g. but not necessarily limited to large volume ascites, shortness of breath on exertion, pain requiring opioid medication, signs of (sub)ileus\n4. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, recent (within 3 months) myocardial infarction, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n5. 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. Patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease (optional criteria that is dependent on the patient population under investigation).\n6. Resting electrocardiography (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, conges-tive heart failure, QTcF prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n   a. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with olaparib, durvalumab or the combination may be included only after consultation with the coordinating investigator.\n8. Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of myelodysplastic syndrome\u002Facute myeloid leukemia (MDS\u002FAML).\n9. Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry\n10. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n11. Evidence of central nervous system (CNS) or leptomeningeal metastases.\n12. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. 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 or any psychiatric disorder that prohibits obtaining informed consent.\n13. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders or any status that might interfere with resorption of the respective study drugs, e.g. parenteral nutrition, short bowel syndrome likely to interfere with absorption of the study medication.\n14. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n15. History of active primary immunodeficiency\n16. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B or hepatitis C.\n\n    1. Active HBV is defined by a known positive 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    2. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA\n17. ECOG performance status (PS) ≥2 or general condition that might interfere with the compliance with the study protocol\n18. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n\n    Prior \u002F concomitant therapy:\n19. Prior antineoplastic therapy for ovarian, fallopian tube or primary peritoneal cancer\n20. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n21. Any concurrent chemotherapy, investigational medicinal product (IMP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n22. Patients planned for neoadjuvant chemotherapy or deemed unresectable at laparoscopy\n23. Concomitant use of known strong cytochrome P450 3A (CYP3A) inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n24. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents\n25. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery\n26. History of allogenic organ transplantation\n27. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n28. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.\n29. Prior treatment with olaparib or any other poly \\[ADP-ribose\\] polymerase (PARP) inhibitor\n30. Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to inclusion criteria no. 16)\n\n    Other exclusions:\n31. Patients who are pregnant or breast-feeding or patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after the last dose of study drug(s).\n32. Involvement in the planning and\u002For conduct of the study\n33. Participation in another interventional clinical study with an investigational product during the last with the last 3 months.\n34. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n35. Previous enrolment in the present study.\n36. Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.\n\n    Additional Durvalumab-specific exclusion criteria for cohort B:\n37. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤28 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or pharmacokinetic (PK) properties of an agent, a longer wash-out period will be required.\n38. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n    1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the coordinating investigator.\n    2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the coordinating investigator.\n39. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n40. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: local surgery of isolated lesions for palliative intent is acceptable.\n41. History of allogenic organ transplantation.\n42. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome \\[granulomatosis with polyangiitis, graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n    1. Patients with vitiligo or alopecia\n    2. Patients with hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement\n    3. Any chronic skin condition that does not require systemic therapy\n    4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n    5. Patients with celiac disease controlled by diet alone\n43. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring (Adverse Events) AEs or compromise the ability of the patient to give written informed consent.\n44. History of another primary malignancy except for\n\n    1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IMP and of low potential risk for recurrence\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    3. Adequately treated carcinoma in situ without evidence of disease\n45. History of leptomeningeal carcinomatosis\n46. Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry.\n47. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)\n48. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus (HBV) surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-hepatitis-B-core (HBc)\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n49. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n50. Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP. Note: patients, if enrolled, should not receive live vaccine whilst receiving IMP and up to 30 days after the last dose of IMP.\n51. Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment or other immunotherapies\n52. Patients who have received prior anti-programmed cell death-protein 1(PD-1), anti PD-L1 or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4):\n\n    1. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n    2. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n    3. Must not have experienced a ≥grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. Note: Patients with endocrine AE of ≤grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if rechallenged, and not currently require maintenance doses of \\>10 mg prednisone or equivalent per day.\n53. Patients planned for neoadjuvant chemotherapy (e.g. but not exclusively due to extend of disease spread or poor general condition etc.).\n54. (sub)ileus or signs of malignant bowel obstruction.",{"count":61,"type":21},60,[24],"This is a multi-center, prospective, open-label, phase II trial. Patients with suspected advanced ovarian cancer planned to undergo diagnostic laparoscopy for histologic confirmation and evaluation of disease spread will be registered into the trial after providing a 1st written informed consent.",[65],"Epithelial Ovarian Cancer",[65,67,68],"Olaparib","Durvalumab","2025-09-30",{"date":71,"type":43},"2025-10-03",{"date":73,"type":43},"2022-05-05",{"date":75,"type":21},"2028-06",{"name":49,"class":50},6,""]