Gynecologic Oncology Clinical Trials
Central to the department’s mission of providing exceptional research-driven care is the development of clinical research trials, including prevention trials, innovative surgical trials and therapeutic trials. The following is a list of ongoing major therapeutic trials.
Central to the department’s mission of providing exceptional research-driven care is the development of clinical research trials, including prevention trials, innovative surgical trials and therapeutic trials. The following is a list of ongoing major therapeutic trials.
Updated 09/11/2020
Ovarian
Window-of-Opportunity Studies
2015-0519 (AZD 1775): A pilot study of Wee1 inhibition induction prior to tumor reductive surgery in ovarian cancer
2018-0775 (NOW) Olaparib in treating patients with newly diagnosed BRCA-mutant ovarian, primary peritoneal, or fallopian cancer before surgery
Post-Completion of Primary Therapy
2015-0520 (bevacizumab): Phase II investigation of bevacizumab for the treatment of second-look positive epithelial ovarian cancer
Recurrent - Platinum Sensitive
2020-0224 (NRG-GY021) Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
Recurrent - Platinum Resistant
2016-0093 (durvalumab, tremelimumab): Randomized phase II trial of durvalumab (MEDI4736) and tremelimumab administered in combination versus sequentially in recurrent platinum-resistant epithelial ovarian cancer
2017-0404 (niraparib, copanlisib): A phase Ib study of the oral PARP inhibitor niraparib with the intravenous PI3K inhibitor copanlisib for recurrent endometrial and recurrent ovarian, primary peritoneal, or fallopian tube cancer
2017-0672 (cyclophosphamide, fludarabine, LN-145, interleukin 2): Clinical study to assess efficacy and safety of LN-145 (autologous centrally manufactured tumor infiltrating lymphocytes) across multiple tumor types
2016-0400 (utomilumab): Phase I/Ib study of adoptive cellular therapy using autologous IL-21-primed CD8+ tumor antigen-specific T cells in combination with utomilumab (PF-05082566) in patients with platinum resistant ovarian cancer
2017-0671 (cyclophosphamide, fludarabine, MDA-TIL, interleukin 2): Clinical study to assess efficacy and safety of MDA-TIL (Autologous Expanded Tumor Infiltrating Lymphocytes) across multiple tumor types
2016-0677 (AZD1775, olaparib): A randomized 2-arm, non-comparative phase 2 study of AZD1775 alone or AZD1775 and olaparib in ovarian cancer patients who have progressed during PARP inhibition
2019-0149 (D-AXL) AVB-S6-500 and durvalumab in treating patients with platinum-resistant or recurrent ovarian, fallopian tube, or primary peritoneal cancer
Rare Tumors (Ovarian)
Low-Grade serous, neoadjuvant
2017-0405 (fulvestrant + abemaciclib) A pilot phase II study of neoadjuvant fulvestrant plus abemaciclib in women with advanced low grade serous carcinoma
Low-Grade serous, primary
2019-1245 (NRG-GY019) Randomized phase III, two-arm trial of paclitaxel/carboplatin/maintenance letrozole versus letrozole monotherapy in patients with stage II-IV, primary low-grade serous carcinoma of the ovary or peritoneum
Low-Grade serous, recurrent
GOG3026 A phase II trial of ribociclib (LEE011) plus letrozole in women with recurrent low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum
Endometrial
Primary Therapy (Newly Diagnosed, Untreated)
2014-0944 Phase II study of the levonorgestrel intrauterine device alone or in combination with the mTOR inhibitor, everolimus, for the treatment of complex atypical hyperplasia and stage Ia Grade 1 endometrial cancer
Advanced or Recurrent
2015-0723 (enzalutamide, carboplatin, paclitaxel): A phase II study with a limited safety lead-in of enzalutamide in combination with carboplatin and paclitaxel in advanced stage or recurrent endometrioid endometrial cancer
2017-0404 (niraparib, copanlisib): A phase Ib study of the oral PARP inhibitor niraparib with the intravenous PI3K inhibitor copanlisib for recurrent endometrial and recurrent ovarian, primary peritoneal, or fallopian tube cancer
2015-0961 (ribociclib, everolimus, letrozole): A phase II, single-arm study of ribociclib (LEE011), everolimus, and letrozole, in patients with advanced or recurrent endometrial carcinoma
GOG3041 (DUO-E) Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
Cervical, vaginal, vulvar
Newly Diagnosed
RTOG0724 (chemo + pelvic radiation): Phase III randomized study of concurrent chemotherapy and pelvic radiation therapy with or without adjuvant chemotherapy in high-risk patients with early-stage cervical carcinoma following radical hysterectomy
Recurrent, Metastatic
2017-0505 A phase 2, multicenter study to evaluate the efficacy and safety using autologous tumor infiltrating lymphocytes (LN-145) in patients with recurrent, metastatic or persistent cervical carcinoma
2017-0548 Phase I multi-center study of stereotactic ablative radiotherapy (SABR) in combination with durvalumab and tremelimumab in patients with recurrent/metastatic advanced cervical, vaginal, or vulvar cancer
Multiple solid tumor sites
Advanced or Recurrent (Previously Treated)
2011-0216 (siRNA-EphA2-DOPC): EphA2 gene targeting using neutral liposomal small interfering RNA delivery (IND# 72924): A phase I clinical trial
2017-0302 (MEDI0457, durvalumab): A phase 2, open-label study to evaluate efficacy of combination treatment with MEDI0457 (INO-3112) and durvalumab (MEDI4736) in patients with recurrent/metastatic Human Papilloma Virus associated cancers
2017-0264 (ipilimumab, nivolumab): Phase Ib clinical investigation of intraperitoneal ipilimumab and nivolumab in patients with peritoneal carcinomatosis due to gynecologic cancers
2016-1129 (selumetinib + olaparib): Evaluation of the combination of selumetinib and olaparib in endometrial, ovarian and other solid tumors with Ras pathway alterations, and ovarian tumors with PARP resistance
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