Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation

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Peritoneal Cancer Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, 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Peritoneal Cancer HIPEC After Initial CRS in Patients Who Have Received NACT Study of Ramucirumab in Ovarian Cancer Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum Vaccine Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC). Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma Genomic BRCA and Extensive ovArian Cancer Testing A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43) Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer EGEN-001 and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer Neoadjuvant Therapy for Ovarian Cancer Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin 18F-CP18 Imaging Studies for Cancer Treatment With Birinapant Phase 2, A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer Depression Treatment and Screening in Ovarian Cancer Patients Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel Bevacizumab for Primary Ovarian Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer Anti—PD-L1 and SAbR for Ovarian Cancer Autologous OC-L Vaccine and Ovarian Cancer S9912 Combination Chemo in Stage III Ovarian Cancer, Study of Paclitaxel in Patients With Ovarian Cancer Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma PDL-1 Inhibition and Focal Sensitizing Radiotherapy in Recurrent Ovarian/Primary Peritoneal/Fallopian Tube Cancers. Guadecitabine and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Physical Activity Monitored by Fitbit Charge 2 in Improving Quality of Life in Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer RO4929097 in Treating Patients With Recurrent and/or Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Vaccine Therapy and Cyclophosphamide in Treating Patients With Stage II-III Breast or Stage II-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Vinorelbine in Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Decitabine, Vaccine Therapy, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Study of Prolanta™ in Recurrent or Persistent Epithelial Ovarian Cancer A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer Phase II ABT-888 With Cyclophosphamide PD 0360324 and Cyclophosphamide in Treating Patients With Recurrent High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2) Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Combination Chemotherapy and Autologous Peripheral Stem Cell Transplant in Treating Patients With Stage III, Stage IV, or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Biomarkers in Predicting Response in Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Treated on GOG-0172 or GOG-0182 Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen Pazopanib Hydrochloride, Paclitaxel, and Carboplatin in Treating Patients With Refractory or Resistant Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Liposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Carboplatin With or Without Decitabine in Treating Patients With Progressive, Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Vaccine Therapy and OPT-821 or OPT-821 Alone in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer in Complete Remission Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer AMG 706 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy ZD9331 With or Without Topotecan in Treating Patients With Refractory or Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Homologous Recombination Inquiry Through Ovarian Malignancy Investigations Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Trial of Best Supportive Care and Either Cisplatin or Paclitaxel to Treat Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer and Inoperable Malignant Bowel Obstruction Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Carboplatin, Gemcitabine Hydrochloride, and ATR Kinase Inhibitor VX-970 in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer PH3 Study of Mirvetuximab Soravtansine vs Investigator’s Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer A Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer Pemetrexed Disodium and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Viral Therapy in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond to Platinum Chemotherapy SJG-136 in Treating Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer That Did Not Respond to Previous Treatment With Cisplatin or Carboplatin A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube Cancer PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer

Brief Title

Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation

Official Title

A Phase I/II Evaluation of Olaparib in Combination With Durvalumab (Medi4736) and Tremelimumab in the Treatment of Recurrent Platinum Sensitive or Resistant or Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Patients Who Carry a BRCA1 or BRCA2 Mutation

Brief Summary

      This phase I/II trial studies the side effects and best dose of olaparib when give together
      with durvalumab and tremelimumab and to see how well they work in treating patients with
      ovarian, fallopian tube, or primary peritoneal cancer with BRCA1 or BRCA2 genetic mutation
      that has come back or has not responded to treatment. Drugs, such as olaparib, may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth and kill tumors
      cells with BRCA1 or BRCA2 mutation. Monoclonal antibodies, such as durvalumab and
      tremelimumab, may help stimulate the immune system in different ways to attack and stop tumor
      cells from growing. Giving olaparib with durvalumab and tremelimumab may work better in
      treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess the safety and toxicity of the combination of PARP inhibitor olaparib with
      anti-PD-L1 antibody durvalumab and anti-CTLA4 antibody tremelimumab. (Phase I) II. To assess
      the impact of the combination of olaparib with durvalumab and tremelimumab on progression
      free survival (PFS) rates. (Phase II)

      SECONDARY OBJECTIVES:

      I. To assess the impact of the combination of olaparib with durvalumab and tremelimumab on
      anti-tumor immune responses in patients with recurrent platinum sensitive or resistant or
      refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer who carry a
      germline and/or somatic BRCA1 or BRCA2 mutation and/or a homologous recombination deficiency
      (HRD).

      II. To assess the impact of the combination of olaparib with durvalumab and tremelimumab on
      PFS and overall survival (OS) in patients with recurrent platinum sensitive or resistant or
      refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer who carry a
      germline and/or somatic BRCA1 or BRCA2 mutation and/or a HRD.

      OUTLINE: This is a phase I, dose-escalation study of olaparib followed by a phase II study.

      Patients receive olaparib orally (PO) twice daily (BID), and tremelimumab intravenously (IV)
      over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up
      to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with
      tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats
      every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up at 30 and 90 days, and every 2
      months thereafter.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Incidence of dose-limiting toxicities (DLTs) defined as the rate of drug-related grade 3-5 adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (Phase I)

Secondary Outcome

 Anti-tumor immune response of the treatment combination assessed in tumor biopsy

Condition

BRCA1 Gene Mutation

Intervention

Durvalumab

Study Arms / Comparison Groups

 Treatment (olaparib, tremelimumab, durvalumab)
Description:  Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

36

Start Date

June 29, 2017

Completion Date

December 15, 2021

Primary Completion Date

December 29, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have platinum-sensitive or platinum-resistant recurrent or persistent or
             refractory ovarian, fallopian tube, or primary peritoneal carcinoma AND have one or
             more of the following characteristics documented on a validated platform (documented
             genetic test report is required). Historic report is permitted.

          -  A germline BRCA1 or BRCA2 deleterious alteration.

          -  A somatic mutation in BRCA1 or BRCA2 detected in a tumor sample or on circulating
             tumor DNA

          -  Carry a known or likely loss of function alteration in one or more of the homologous
             recombination or mismatch repair pathways genes

          -  Demonstrate a genomic phenotype of HR deficiency as measured by a LOH-high score.

               -  Recurrent ovarian cancer is defined as recurrence of disease in a patient who
                  achieved initial complete response to primary therapy

               -  Persistent ovarian cancer is defined as having residual disease in the form of
                  elevated tumor markers or microscopic or clinically evident disease in a patient
                  who has completed and apparently responded to initial chemotherapy

               -  Refractory ovarian cancer is defined as patients who have failed to achieve at
                  least a partial response to therapy including patients with either stable disease
                  or disease progression during primary therapy

               -  Platinum-sensitive is defined as achievement of documented response to initial
                  platinum-based treatment and has been off treatment for an extended period of
                  time (more than 6 months)

               -  Platinum-resistant is defined as relapse within 6 months of last platinum-based
                  chemotherapy or progression while on platinum-based therapy

          -  All patients must have measurable disease as defined by immune-related Response
             Evaluation Criteria in Solid Tumors (irRECIST); measurable disease is defined as 10 mm
             in the longest diameter by computed tomography (CT) or magnetic resonance imaging
             (MRI) scan (or no less than double the slice thickness) for non- nodal lesions and >=
             15 mm in short axis for nodal lesions, 20 mm by chest X-ray, a lymph node must be >=
             15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to
             be no greater than 5 mm)

          -  Must have archival tissue available for PD-L1 assessment

          -  Patients should be free of active infection requiring antibiotics (with the exception
             of uncomplicated urinary tract infection [UTI])

          -  Patients who have the following risk factors are considered to be at increased risk
             for cardiac toxicities and may be enrolled only with increased monitoring: i) prior
             treatment with anthracyclines; ii) prior treatment with trastuzumab; iii) a New York
             Heart Association classification of II controlled with treatment; iv) prior central
             thoracic radiation therapy (RT), including RT to the heart

          -  Any hormonal therapy being taken as a treatment for cancer must be discontinued at
             least one week prior to registration; continuation of hormone replacement therapy e.g.
             thyroid hormone replacement therapy is permitted

          -  Able to tolerate oral medications and no GI illnesses that would preclude absorption
             of olaparib

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Life expectancy of > 6 months

          -  Hemoglobin >= 10 g/dL (no blood transfusion in the 28 days prior to entry [olaparib
             guidelines])

          -  White blood cell count (WBC) > 3 x 10^9/L

          -  Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>=1500 per mm^3)

          -  Platelet count >= 100 x 10^9/L (>= 100,000 per mm^3)

          -  Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not
             apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent
             hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or
             hepatic pathology), who will be allowed only in consultation with their physician

          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 x institutional upper limit of normal unless liver metastases are present, in
             which case it must be =< 5 x ULN

          -  Creatinine =< 1.5 x ULN, serum creatinine clearance (CL) > 51 ml/min (by the
             Cockcroft- Gault equation)

          -  Female subjects must either be of non-reproductive potential (i.e., post-menopausal by
             history: >= 60 years old and no menses for >=1 year without an alternative medical
             cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history
             of bilateral oophorectomy) or must have a negative serum pregnancy test within 28 days
             of study treatment, confirmed prior to treatment on day 1

          -  Participants of child-bearing potential must agree to use two highly effective and
             acceptable forms of contraception from screening, throughout their participation in
             the study and for 180 days after the last dose of durvalumab + tremelimumab
             combination therapy or 90 days after last dose of durvalumab or olaparib, whichever is
             the longer time period (e.g., hormonal or barrier method of birth control); 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

          -  Participant or legal representative must understand the investigational nature of this
             study and sign an Independent Ethics Committee/Institutional Review Board approved
             written informed consent form prior to receiving any study related procedure

          -  Subject is willing and able to comply with the protocol for the duration of the study
             including undergoing treatment and scheduled visits and examinations including follow
             up

        Exclusion Criteria:

          -  Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
             staff and/or staff at the study site); previous enrollment in the present study

          -  Participation in another clinical study with an investigational product during the
             last 4 weeks (prior use of bevacizumab in the upfront setting is allowed)

          -  History of discontinuation of any previous treatment with PARP inhibitors, including
             olaparib, or a PD-1 or PD-L1 inhibitor, including durvalumab or anti-CTLA4 antibody,
             including tremelimumab due to toxicity.

          -  Patients with myelodysplastic syndrome/acute myeloid leukemia

          -  History and/or confirmed interstitial lung disease (ILD)/pneumonitis, extensive
             bilateral lung disease on high-resolution computed tomography (HRCT) scan

          -  Concomitant use of a strong CYP3A inhibitors (e.g., itraconazole, telithromycin,
             clarithromycin, ketoconazole, voriconazole, nefazodone, posaconazole, ritonavir,
             lopinavir/ritonavir, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) and
             moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin,
             crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole. Fosamprenavir,
             imatinib, verapamil)

          -  Concomitant use of strong CYP3A inducers (e.g., phenytoin, rifampicin, carbamazepine,
             St. John's wort) and moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine,
             modafinil, nafcillin)

          -  History of another primary malignancy except for:

               -  Malignancy treated with curative intent and with no known active disease >= 5
                  years before the first dose of study drug and of low potential risk for
                  recurrence

               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
                  of disease (e.g. basal cell or squamous cell carcinoma of the skin)

               -  Adequately treated carcinoma in situ without evidence of disease (e.g., breast
                  and cervical cancer in situ)

          -  Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy,
             endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal
             antibodies, radiotherapy or other investigational agent) =< 21 days prior to the first
             dose of study drug and within 6 weeks for nitrosourea or mitomycin C)

          -  Mean QT interval corrected for heart rate (QTcF) >= 470 ms calculated from 3
             electrocardiograms (ECGs) using Fridericia's correction

          -  Patients with history of myocardial infarction within 6 months

          -  Current or prior use of immunosuppressive medication within 28 days before the first
             dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or
             systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of
             prednisone, or an equivalent corticosteroid

          -  Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade
             >= 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is
             not reasonably expected to be exacerbated by the investigational product may be
             included (e.g., hearing loss, peripherally neuropathy)

          -  Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous
             immunotherapy agent, or any unresolved irAE > grade 1

          -  Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects
             with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within
             the past 2 years) are not excluded

          -  Active or prior documented inflammatory bowel disease (e.g., Crohn?s disease,
             ulcerative colitis)

          -  Patients with thyroid dysfunction if not adequately controlled

          -  History of primary immunodeficiency

          -  History of allogeneic organ transplant

          -  History of hypersensitivity to durvalumab, tremelimumab, olaparib or, any excipient

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active
             bleeding diatheses including any subject known to have evidence of, or test positive
             for, acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV),
             or psychiatric illness/social situations that would limit compliance with study
             requirements or compromise the ability of the subject to give written informed consent

          -  Known history of previous clinical diagnosis of tuberculosis

          -  History of leptomeningeal carcinomatosis

          -  Receipt of live attenuated vaccination within 30 days prior to study entry or within
             30 days of receiving durvalumab (e.g. live attenuated influenza vaccine [LAIV],
             measles/mumps/rubella vaccine [MMR], variola virus vaccine [VAR], zoster, yellow
             fever, etc.)

          -  Female subjects who are pregnant, breast-feeding, or of reproductive potential who are
             not employing an effective method of birth control from screening to 180 days after
             the last dose of durvalumab + tremelimumab + olaparib combination therapy or 90 days
             after the last dose of durvalumab and olaparib therapy, whichever is the longer time
             period

          -  Any condition that, in the opinion of the investigator, would interfere with
             evaluation of study treatment or interpretation of patient safety or study results or,
             is an unsuitable candidate to receive study drug (e.g. inability to tolerate oral
             medications which would preclude absorption of olaparib)

          -  Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive
             of but not limited to surgery, radiation and/or corticosteroids

          -  Subjects with uncontrolled seizures

          -  Dependency on IV hydration or total parenteral nutrition (TPN)
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kunle Odunsi, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02953457

Organization ID

I 288216

Secondary IDs

NCI-2016-01598

Responsible Party

Sponsor

Study Sponsor

Roswell Park Cancer Institute

Collaborators

 AstraZeneca

Study Sponsor

Kunle Odunsi, Principal Investigator, Roswell Park Cancer Institute


Verification Date

July 2020