Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) Availability & Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer Interactive Educational Website for Women With Ovarian Cancer & Caregivers PH I SRC Kinase, Dasatinib Combo Paclitaxel & Carboplatin in Pts w Ovarian, Peritoneal, & Tubal Cancer Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer) Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Liposomal Doxorubicin and Etoposide in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer SCH-58500 in Treating Patients With Primary Ovarian, Fallopian Tube, or Peritoneal Cancer (C95084) Cisplatin and Gemcitabine in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission Letrozole in Patients With Ovarian Tumors Tivozanib As Maintenance Therapy In GYN Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer Low Dose Cyclophosphamide +/– Nintedanib in Advanced Ovarian Cancer Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or 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, Recovery & Survival Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer – A Feasibility Study Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary 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

Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Official Title

Phase II Randomized Trial of Nivolumab With or Without Ipilimumab in Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Brief Summary

      This randomized phase II trial studies how well nivolumab works with or without ipilimumab in
      treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that
      has not responded after prior treatment (persistent) or has come back (recurrent).
      Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the
      body's immune system attack the cancer, and may interfere with the ability of tumor cells to
      grow and spread.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. To estimate the proportion of patients who have objective tumor response (complete or
      partial) by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in patients
      with persistent or recurrent epithelial ovarian, fallopian tube, primary peritoneal cancers,
      treated with nivolumab or the combination of nivolumab and ipilimumab and to assess the
      difference in objective response rate (ORR) between patients treated with nivolumab versus
      those treated with the combination of nivolumab and ipilimumab.

      SECONDARY OBJECTIVES:

      I. To estimate the progression-free survival (PFS) hazard ratio for patients treated with
      nivolumab versus those treated with the combination of nivolumab and ipilimumab.

      II. To estimate and compare the duration of overall survival (OS) for patients treated with
      nivolumab or the combination of nivolumab and ipilimumab.

      III. To determine the frequency and severity of adverse events associated with treatment with
      nivolumab or the combination of nivolumab and ipilimumab as assessed by Common Terminology
      Criteria for Adverse Events (CTCAE).

      IV. To determine whether cellular and molecular laboratory parameters in pre-treatment tissue
      and peripheral blood specimens predict overall survival (OS), tumor response by modified
      RECIST 1.1, and progression-free survival (PFS):

      IVa. PD-L1 expression in tumor cells and tumor-infiltrating lymphocytes (TILs) measured by
      quantitative immunohistochemistry (IHC).

      IVb. Natural anti-tumor immunity in tumor cells and TILs measured using IHC and T cell
      repertoire analyses.

      IVc. Tumor "immunogenicity" as determined by the neo-epitope landscape using next-generation
      whole exome sequencing (NGS).

      IVd. Anti-tumor immune response in peripheral blood, including serologic responses and
      analysis of T cell receptor (TCR) repertoires by deep sequencing.

      IVe. Shift in quantitative laboratory peripheral blood parameters after the first 6 and 12
      weeks of therapy.

      OUTLINE: Patients are randomized to 1 of 2 treatment groups.

      GROUP I:

      INDUCTION: Patients receive nivolumab intravenously (IV) over 30 minutes every 2 weeks.
      Treatment repeats every 4 weeks for 2 cycles in the absence of disease progression or
      unacceptable toxicity.

      MAINTENANCE: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats
      every 4 weeks for up to 21 cycles in the absence of disease progression or unacceptable
      toxicity.

      GROUP II:

      INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes.
      Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or
      unacceptable toxicity.

      MAINTENANCE: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats
      every 4 weeks for up to 21 cycles in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up for 100 days, every 3 months
      for 2 years, and then every 6 months for 3 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Tumor Response

Secondary Outcome

 Progression-free Survival (PFS)

Condition

Recurrent Fallopian Tube Carcinoma

Intervention

Ipilimumab

Study Arms / Comparison Groups

 Group I (nivolumab)
Description:  INDUCTION: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats every 4 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats every 4 weeks for up to 21 cycles 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

100

Start Date

June 29, 2015

Completion Date

December 31, 2020

Primary Completion Date

September 5, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or
             primary peritoneal cancer with documented disease progression (disease not amendable
             to curative therapy); histologic confirmation of the original primary tumor is
             required via the pathology report; NOTE: patients with mucinous histology are NOT
             eligible; patients with carcinosarcoma histology are NOT eligible

          -  All patients must have measurable disease as defined by RECIST 1.1; measurable disease
             is defined as at least one lesion that can be accurately measured in at least one
             dimension (longest diameter to be recorded); each lesion must be >= 10 mm when
             measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper
             measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes
             must be >= 15 mm in short axis when measured by CT or MRI

          -  Patients must have at least one "target" lesion to be used to assess response on this
             protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be
             designated as "non-target" lesions unless progression is documented or a biopsy is
             obtained to confirm persistence at least 90 days following completion of radiation
             therapy

          -  Appropriate for study entry based on the following diagnostic workup:

               -  History/physical examination within 28 days prior to registration

               -  Imaging of target lesion(s) within 28 days prior to registration

               -  Further protocol-specific assessments:

                    -  Recovery from effects of recent surgery, radiotherapy or chemotherapy

                    -  Free of active infection requiring antibiotics (with the exception of
                       uncomplicated urinary tract infection [UTI])

                    -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                       least one week prior to registration

                    -  Any other prior therapy directed at the malignant tumor including
                       chemotherapy, targeted agents, immunologic agents, and any investigational
                       agents, must be discontinued at least 4 weeks prior to registration (6 weeks
                       for nitrosoureas or mitomycin C)

                    -  Any prior radiation therapy must be completed at least 4 weeks prior to
                       registration

                    -  At least 4 weeks must have elapsed since major surgery

          -  Patients are allowed to have received up to three prior cytotoxic regimens for
             treatment of their epithelial ovarian, fallopian tube, or primary peritoneal cancer;
             they must have had one prior platinum-based chemotherapeutic regimen for management of
             primary disease, possibly including intra-peritoneal therapy, consolidation,
             biologic/targeted (non-cytotoxic) agents or extended therapy
             (maintenance/consolidation) administered after surgical or non-surgical assessment;
             patients are allowed to have received, but are not required to have received, one to
             two cytotoxic regimens for management of recurrent or persistent disease; (for the
             purposes of this study poly adenosine diphosphate [ADP] ribose polymerase [PARP]
             inhibitors given for recurrent or progressive disease will be considered cytotoxic;
             PARP inhibitors given as maintenance therapy in continuation with management of
             primary disease will not be considered as a separate cytotoxic regimen); if two
             cytotoxic regimens had been received for management of recurrent or persistent
             disease, one of these regimens would have had to contain either a platinum or a taxane
             agent

          -  Performance status of 0, 1 or 2 within 28 days prior to registration

          -  Absolute neutrophil count (ANC) >= 1,500/ul (within 14 days prior to registration)

          -  Platelets >= 100,000/ul (within 14 days prior to registration)

          -  Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14
             days prior to registration)

          -  Bilirubin =< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =< 3.0 mg/dL
             is acceptable (within 14 days prior to registration)

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within
             14 days prior to registration)

          -  Albumin >= 2.8 g/dL (within 14 days prior to registration)

          -  Adequate thyroid function within 28 days prior to registration defined as serum
             thyroid-stimulating hormone (TSH) in normal range

          -  The patient or a legally authorized representative must provide study-specific
             informed consent prior to study entry

          -  Platinum-free interval (PFI) - patients must have progressed < 12 months after
             completion of their last platinum-based chemotherapy; the date (platinum free
             interval) should be calculated from the last administered dose of platinum therapy to
             documentation of progression

          -  Adequate oxygen saturation via pulse oximeter within 28 days prior to registration
             (i.e., patient can NOT have CTCAE hypoxia grade 2 or greater)

          -  Left ventricular ejection fraction (LVEF) >= 50% (measured within 28 days of study
             entry)

        Exclusion Criteria:

          -  Patients who have had prior therapy with nivolumab or with an anti-programmed cell
             death (PD)-1, anti-PD-ligand (L)1, anti-PD-L2, anti-cytotoxic T-lymphocyte-antigen
             (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell
             co-stimulation or immune check point pathways

          -  History of severe hypersensitivity reaction to any monoclonal antibody

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer and other specific malignancies are excluded if there is any
             evidence of other malignancy being present within the last three years (2 years for
             breast cancer); patients are also excluded if their previous cancer treatment
             contraindicates this protocol therapy

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
             THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within
             the last three years are excluded; patients may have received prior adjuvant
             chemotherapy and radiotherapy for localized breast cancer, provided that it was
             completed more than 2 years prior to registration, and the patient remains free of
             recurrent or metastatic disease and hormonal therapy has been discontinued; patients
             who have received prior radiotherapy to any portion of the abdominal cavity or pelvis
             or thoracic cavity within the last three years are excluded; prior radiation for
             localized cancer of the head and neck or skin is permitted, provided that it was
             completed more than three years prior to registration, and the patient remains free of
             recurrent or metastatic disease

          -  Patients with uncontrolled illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure and unstable angina pectoris

          -  Patients with history of organ transplant

          -  Patients who are pregnant or nursing; women of child-bearing potential (WOCBP) must
             agree to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) prior to study entry and for the duration of study participation; WOCBP
             should use an adequate method to avoid pregnancy for 23 weeks after the last dose of
             investigational drug; WOCBP must have a negative serum or urine pregnancy test
             (minimum sensitivity 25 IV/L or equivalent units of human chorionic gonadotropin
             [HCG]) within 24 hours prior to the start of nivolumab or nivolumab + ipilimumab;
             women must not be breastfeeding; women who are not of childbearing potential (i.e.,
             who are postmenopausal or surgically sterile) do not require contraception; women of
             childbearing potential (WOCBP) is defined as any female who has experienced menarche
             and who has not undergone surgical sterilization (hysterectomy and/or bilateral
             oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12
             month amenorrhea in a woman over 45 in the absence of other biological or
             physiological causes; in addition, women under the age of 55 must have a documented
             serum follicle stimulating hormone (FSH) level greater than 40 mIU/mL; if, following
             initiation of the investigational product(s), it is subsequently discovered that a
             study subject is pregnant or may have been pregnant at the time of investigational
             product exposure, including during at least 6 half-lives after product administration,
             the investigational product will be permanently discontinued in an appropriate manner
             (e.g., dose tapering if necessary for subject safety); the investigator must report
             this event and any outcomes by amendment through Cancer Therapy Evaluation Program
             (CTEP)-Adverse Event Reporting System (AERS); protocol-required procedures for study
             discontinuation and follow-up must be performed on the subject unless contraindicated
             by pregnancy (e.g., X-ray studies); other appropriate pregnancy follow-up procedures
             should be considered if indicated; in addition, the investigator must report and
             follow-up on information regarding the course of the pregnancy, including perinatal
             and neonatal outcome; infants should be followed for a minimum of 8 weeks

          -  History or evidence upon physical examination of central nervous system (CNS) disease,
             including primary brain tumor, seizures which are not controlled with non-enzyme
             inducing anticonvulsants, any brain metastases and/or epidural disease, or history of
             cerebrovascular accident (cerebrovascular accident [CVA], stroke), transient ischemic
             attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of
             study treatment

          -  In order for patients with known history of testing positive for human
             immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) to be
             eligible, they must be on a stable highly active antiretroviral therapy (HAART)
             regimen, have cluster of differentiation (CD)4 counts > 350, with no detectable viral
             load on quantitative polymerase chain reaction (PCR)

          -  Patients with treated hepatitis virus infections (hepatitis B or hepatitis C) are
             eligible if they have been definitively treated for 6 months, have no detectable viral
             load on quantitative PCR, and liver function tests (LFTs) meet eligibility
             requirements

          -  Patients with active autoimmune disease or history of autoimmune disease that might
             recur, which may affect vital organ function or require immune suppressive treatment
             including systemic corticosteroids, should be excluded; these include but are not
             limited to patients with a history of immune related neurologic disease, multiple
             sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia
             gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE),
             connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's,
             ulcerative colitis, hepatitis; and patients with a history of toxic epidermal
             necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be
             excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed
             with replacement hormones including physiologic corticosteroids are eligible; patients
             with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis
             controlled with topical medication and patients with positive serology, such as
             antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the
             presence of target organ involvement and potential need for systemic treatment but
             should otherwise be eligible

          -  Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus,
             residual hypothyroidism due to autoimmune condition only requiring hormone replacement
             (such as Hashimoto's thyroiditis), psoriasis not requiring systemic treatment, or
             conditions not expected to recur in the absence of an external trigger (precipitating
             event)

          -  Patients should be excluded if they have a condition requiring systemic treatment with
             either corticosteroids (> 10 mg daily prednisone equivalents) or other
             immunosuppressive medications within 14 days of study drug administration; inhaled or
             topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents
             are permitted in the absence of active autoimmune disease; patients are permitted to
             use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids
             (with minimal systemic absorption); a brief course of corticosteroids for prophylaxis
             (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g.,
             delayed-type hypersensitivity reaction caused by contact allergen) is permitted

          -  Any of the following within 2 months of registration: active peptic ulcer disease,
             diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, malabsorption
             syndrome; any of the following within 6 months of registration: intra-abdominal
             abscess, gastrointestinal obstruction requiring parenteral hydration and/or nutrition,
             gastrointestinal perforation; Note: complete resolution of an intra-abdominal abscess
             must be confirmed prior to registration even if the abscess occurred more than 6
             months prior to registration

          -  No planned concomitant, non-protocol directed anti-cancer therapy

          -  Grade >= 2 peripheral neuropathy
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dimitry Zamarin, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02498600

Organization ID

NCI-2014-02424

Secondary IDs

NCI-2014-02424

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 NRG Oncology

Study Sponsor

Dimitry Zamarin, Principal Investigator, NRG Oncology


Verification Date

September 2020