Gynecologic Oncology Clinical Trials

Updated 05/02/2019

Ovarian

Primary Therapy - Newly Diagnosed, untreated

• 2014-0662 (pembrolizumab + chemo): Matched paired pharmacodynamics and feasibility study of pembrolizumab in combination with chemotherapy in frontline ovarian cancer
• 2015-0900 (durvalumab + chemo): Matched paired pharmacodynamics and feasibility study of durvalumab in combination with chemotherapy in frontline ovarian cancer

Primary Maintenance Therapy for Advanced Stage

• GOG3020 (rucaparib, nivolumab) ATHENA: A multicenter, randomized, double-blind, placebo-controlled phase 3 study in ovarian cancer patients evaluating rucaparib and nivolumab as maintenance treatment following response to front-line platinum-based chemotherapy

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 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

Window-of-Opportunity Studies

• 2015-0519 (AZD 1775): A pilot study of Wee1 inhibition induction prior to tumor reductive surgery in ovarian cancer

Rare Tumors (Ovarian)

Sex Cord Stromal, Primary or Recurrent, Chemo-naïve

• GOG 0264 (paclitaxel + carboplatin vs bleomycin, etoposide, + cisplatin):  A randomized phase II trial of paclitaxel and carboplatin vs. bleomycin, etoposide, and cisplatin for newly diagnosed advanced stage and recurrent chemo-naive sex-cord stromal tumors of the ovary   

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
• 2018-0601 (ARQ-092 + anastrozole): An open-label Phase 1b study of ARQ 092 in combination with other antineoplastic agents in subjects with selected solid tumors

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