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
Neoadjuvant therapy
2022-0451 (Imunon): A phase II study evaluating the effect of GEN-1 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on second look laparoscopy (SLL) when administered in combination with Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in subjects newly diagnosed with advanced ovarian, fallopian tube or primary peritoneal cancer.
2022-0621 (OPAL): Cohort C: Open-label phase 2, randomized, controlled multicenter study comparing Niraparib versus Platinum-Taxane doublet chemotherapy as neoadjuvant treatment in participants with homologous recombination-deficient stage III/IV 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
2022-0685 (PCB): Phase II investigation of Pembrolizumab in combination with Bevacizumab and Oral Cyclophosphamide in patients with high grade Ovarian Cancer and surgically documented minimal residual disease after frontline therapy
Recurrent - Platinum Resistant
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.
2022-0231 (Lurbi, Taxol, Bev): Phase 1b of lurbinectedin in combination with weekly paclitaxel and bevacizumab in platinum-resistant ovarian cancer
2023-0585 (Combo MATCH): EAY191-N4: A randomized trial of Selumetinib and Olaparib or Selumetinib alone in patients with recurrent or persistent Ras pathway mutant Ovarian and Endometrial cancers
2022-0687 (TROP2): Phase I/II study of TROP2 CAR engineered IL15-transduced cord blood-derived NK cells delivered intraperitoneally for the management of platinum resistant ovarian cancer, mesonephric-like adenocarcinoma, and pancreatic cancer
2022-0696 (GOG-3067 -MAMMOTH): A phase 1/2 dose-escalation and dose-expansion study of ZN-c3 in combination with Niraparib and ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer
Recurrent - Platinum Sensitive
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
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
Clear-cell, recurrent
2022-1047 (Dostarlimab, LB-100): Safety and efficacy of targeting PP2A in ovarian clear cell carcinoma using Dostarlimab and LB-100
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, Upfront)
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
2021-0618 (chemo RTD): Phase I trial evaluating the safety and tolerability of chemoradiation followed by chemotherapy + dostarlimab for stage IIIC, node positive, endometrial cancer
Advanced or Recurrent
2022-0526 (LEAP/DKN-01): Phase 2 study evaluating the efficacy of the combination of DKN-01 (DKK1 inhibitor, Leap Therapeutics) and Pembrolizumab in the treatment of advanced or recurrent endometrial cancer
2022-0751 (E7386, Lenvatinib): An Open-label phase 1b study of E7386 in combination with other Anticancer Drug(s) in subjects with solid tumors
2023-0585 (ComboMATCH): EAY191-N4: A randomized trial of Selumetinib and Olaparib or Selumetinib alone in patients with recurrent or persistent Ras pathway mutant Ovarian and Endometrial cancers
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)
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.
2020-0800 (Bio-Path) A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients with Advanced or Recurrent 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
Last updated January 24, 2024
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