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.
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Clinical trials by disease site
Ovarian
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
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
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
2020-0420 (Avenge) This is an open-label, First-in-Human, Phase 1/2, multicenter study to evaluate the safety and efficacy of a single dose of AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2). It is delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.
2020-1121 (pembrolizumab, lenvatinib) Immunomodulation of the tumor microenvironment in high-grade serous ovarian cancer patients receiving pembrolizumab and lenvatinib monotherapy and combination therapy
2021-0694 (TAME) A pilot study of weekly paclitaxel, bevacizumab, and Tumor Associated Macrophage targeted therapy (zoledronic acid) in women with recurrent, platinum-resistant, Epithelial ovarian, fallopian tube or primary peritoneal cancer
Rare Tumors (Ovarian)
GOG 3051 (BOUQUET) This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors.
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
Clear-cell, recurrent
2021-0511 (EON) EON: A Single-arm Phase II study of Etigilimab (OMP-313M32) in Combination with Checkpoint Inhibition (Nivolumab) in Patients with Platinum-resistant, Recurrent Epithelial Ovarian Cancer
Recurrent Mucinous
2021-0660 (HIPEC) Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)
Endometrial (Uterine)
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
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
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
2020-0545 (CoNteSSa): FIGO 2018 stage IB2 (=2cm - <4 cm) Cervical Cancer Treated with Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and ConservativeSurgery in Cervical Cancer to Preserve Fertility (NeoCon-F)
2019-0919 (Yoga) Yoga Therapy During Chemotherapy and Radiation Treatment for Local-regional 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
2022-0107 (Traction) This is a study to learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment.
Rare Tumors (Cervical)
2021- 0585 (cadonilimab) Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix
Multiple Solid Tumor Sites
2018-0538 (Immatics) Phase 1 study evaluating genetically modified autologous T cells expressing a T-cell receptor recognizing a cancer/germline antigen as monotherapy or in combination with atezolizumab in patients with recurrent and/or refractory solid tumors (ACTengine® IM)
2021-0589 (Xencor) This study is to test the safety and effectiveness of XmAb20717 for participants with advanced rare cancers.
2020-1042 (Alaunos TCR trial) A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors.
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
Surgical Trials
2020-0165 Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
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