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 02/14/2018
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
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
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
- 2013-1035 A phase III Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk 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
- 2015-0961 (everolimus, letrozole, LEE011): A phase II, single-arm study of ribociclib (LEE011), everolimus, and letrozole, in patients with advanced or recurrent endometrial carcinoma
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
Newly Diagnosed, Surgery Only
- 2007-0800 A phase III randomized clinical trial of laparoscopic or robotic radical hysterectomy versus abdominal radical hysterectomy in patients with early stage cervical cancer
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