Gynecologic Oncology Clinical Trials

Updated 06/25/2018

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
• GOG3015 (atezolizumab, paclitaxel, carboplatin, bevacizumab): A phase III, multicenter, randomized study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer

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

• 2015-0647 (emactuzumab, paclitaxel, bevacizumab): A randomized phase II induction discontinuation trial of emactuzumab following paclitaxel and bevacizumab in patients with platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer
• 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
• 2017-0672 (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

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

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

All 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
• 2015-0035 (COTI-2): A phase I study of COTI-2 for the treatment of advanced or recurrent gynecologic malignancies
• 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