Gynecologic Cancer Committee
Gynecologic Cancer Committee Leadership
Chair
Carol Aghajanian, MD
Vice Chair
Paul DiSilvestro, MD
Vice Chair
David Gaffney, MD
Working Groups
Translational Science GYN Cancer Working Group
Chair
Michael Birrer, MD, PhD
Chair
Heather Lankes, PhD
Core Committee Members
- Ronald Alvarez
- Floortje Backes
- Sally Bialy
- Michael Birrer
- Jubilee Brown
- Meg Colahan
- Nicole Copeland
- Allan L. Covens
- William T. Creasman
- Stephanie Gaillard
- Jade Gibson
- Warner Huh
- Ann Klopp
- Elise Kohn
- Panagiotis Konstantinopoulos
- Angela Kuras
- Heather Lankes
- Charles Leath
- Joyce Liu
- Leah Madden
- Robert S. Mannel
- Jessica Marston
- Grace Martin
- Jyoti Mayadev
- Austin Miller
- David Miller
- Kathryn Miller
- Marlyn Molero
- Kathleen Moore
- Kia Neff
- Roisin O’Cearbhaill
- Matthew Powell
- Laura L Reese
- Russell J. Schilder
- Mark Shahin
- Michael Sill
- William Tew
- Krishnansu S. Tewari
- Joan Walker
| Study | Title | Status | Phase | Disease Category | Disease Site |
|---|---|---|---|---|---|
| AGCT1531 |
A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors |
Open to Accrual | III | Gynecologic [GY] | Other |
| 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: A ComboMATCH Treatment Trial |
Open to Accrual | II | Gynecologic [GY] | Multiple |
| EAY191-N5 |
A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination with Palbociclib, a CDK4/6 Inhibitor, in Patients with HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial |
Open to Accrual | II | Gynecologic [GY] | Multiple |
| GOG-0184 |
A RANDOMIZED PHASE III STUDY OF TUMOR VOLUME DIRECTED PELVIC PLUS OR MINUS PARA-AORTIC IRRADIATION FOLLOWED BY CISPLATIN AND DOXORUBICIN OR CISPLATIN, DOXORUBICIN AND PACLITAXEL FOR ADVANCED ENDOMETRIAL CARCINOMA |
Terminated | III | Gynecologic [GY] | Uterine Corpus |
| GOG-0186H |
A Randomized Phase II Evaluation of Weekly Paclitaxel (NSC# 673089) Versus Weekly Paclitaxel with Oncolytic Reovirus (Reolysin NSC # 729968, BB-IND # 13370) in the Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
Complete | II | Gynecologic [GY] | Ovarian |
| GOG-0186K |
A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968 IND #116059) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
Complete | II | Gynecologic [GY] | Ovarian |
| GOG-0199 |
Prospective Study of Risk-Reducing Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer |
Complete | Other | Gynecologic [GY] | Ovarian |
| GOG-0207 |
A Randomized Double-Blind Phase II Trial of Celecoxib, a COX-2 Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or 3)(IND #69,656, Sponsor-GOG) |
Complete | II | Gynecologic [GY] | Cervix |
| GOG-0210 |
A Molecular Staging Study of Endometrial Carcinoma |
Complete | Other | Gynecologic [GY] | Uterine Corpus |
| GOG-0213 |
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination with Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865) |
Closed to Accrual | III | Gynecologic [GY] | Ovarian |
| GOG-0214 |
Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women At High Risk for Ovarian Cancer (IND# 79,610) |
Complete | II | Gynecologic [GY] | Ovarian |
| GOG-0225 |
Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival? |
Closed to Accrual | Other | Gynecologic [GY] | Ovarian |
| GOG-0229O |
A Randomized Phase II with a Safety Lead-In to Assess the Antitumor Efficacy of the MEK Inhibitor Trametinib Alone or in Combination with GSK2141795, an AKT Inhibitor, in Patients with Recurrent or Persistent Endometrial Cancer NCT #01935973 |
Terminated | I | Gynecologic [GY] | Uterine Corpus |
| GOG-0237 |
Comparative Analysis of CA-IX, p16, Proliferative Markers and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients with a Cytologic Diagnosis of Atypical Glandular Cells (AGC) |
Closed to Accrual | Other | Gynecologic [GY] | Cervix |
| GOG-0238 |
A Randomized Trial of Pelvic Irradiation with or Without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus |
Complete | II | Gynecologic [GY] | Uterine Corpus |
| GOG-0239 |
A Phase II Trial of AZD6244 (NSC# 748727, IND# 77782) in Women with Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum |
Terminated | II | Gynecologic [GY] | Ovarian |
| GOG-0260 |
A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
Terminated | II | Gynecologic [GY] | Ovarian |
| GOG-0263 |
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451) |
Terminated | III | Gynecologic [GY] | Cervix |
| GOG-0268 |
A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: NSC# 683864, IND# 61010) in Combination with Carboplatin and Paclitaxel Followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary |
Terminated | II | Gynecologic [GY] | Ovarian |
| GOG-0274 RTOG 1174 |
A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone: THE OUTBACK TRIAL |
Terminated | III | Gynecologic [GY] | Cervix |
| GOG-0277 |
A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma |
Terminated | III | Gynecologic [GY] | Uterine Corpus |
| GOG-0278 |
Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy with Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (=/<2CM) Cervical Cancer |
Complete | Other | Gynecologic [GY] | Cervix |
| GOG-0280 |
A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (IND#77840) (NSC #737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation |
Terminated | II | Gynecologic [GY] | Ovarian |
| GOG-0281 |
A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients with Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer |
Terminated | II/III | Gynecologic [GY] | Ovarian |
| GOG-0286B |
A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer |
Complete | II/III | Gynecologic [GY] | Uterine Corpus |
| GOG-9923 |
A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination with Continuous or Intermittent /CTEP-Supplied Agent ABT-888 (NSC #737664) and CTEP-Supplied Agent Bevacizumab (NSC #704865) in Newly Diagnosed Patients with Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
Complete | I | Gynecologic [GY] | Ovarian |
| GOG-9924 |
A Phase I Pharmacokinetic Study of Intraperitoneal CTEP-Supplied Agent Bortezomib (PS-341, NSC 681239, IND# 58443) and Carboplatin (NSC# 241240) in Patients with Persistent or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
Terminated | I | Gynecologic [GY] | Ovarian |
| GOG-9926 |
A Phase I Evaluation of Extended Field Radiation Therapy with Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women with Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes |
Terminated | I | Gynecologic [GY] | Cervix |
| GOG-9928 |
A Phase I Study of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) (IND #12,484) Administered in Combination with Pegylated Liposomal Doxorubicin (PLD, Doxil (NSC #712227) or Lipodox (NSC #673089) in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
Terminated | I | Gynecologic [GY] | Ovarian |
| NRG-CC010 |
A Phase III Trial of the Impact of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer |
Open to Accrual | III | Gynecologic [GY] | Uterine Corpus |
| NRG-GY001 |
A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women with Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum |
Terminated | II | Gynecologic [GY] | Ovarian |
| NRG-GY002 |
A Phase II Evaluation of Nivolumab, a Fully Human Antibody Against PD-1, in the Treatment of Persistent or Recurrent Cervical Cancer |
Complete | II | Gynecologic [GY] | Cervix |
| NRG-GY003 |
Phase II Randomized Trial of Nivolumab with or Without Ipilimumab in Patients with Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer |
Terminated | II | Gynecologic [GY] | Ovarian |
| NRG-GY004 |
A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
Closed to Accrual | III | Gynecologic [GY] | Ovarian |
| NRG-GY005 |
A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS) |
Closed to Accrual | II/III | Gynecologic [GY] | Ovarian |
| NRG-GY006 |
A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer |
Complete | III | Gynecologic [GY] | Cervix |
| NRG-GY007 |
A Phase I/II Study of Ruxolitinib with Front-Line Neoadjuvant and Post-Surgical Therapy in Patients with Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
Terminated | I/II | Gynecologic [GY] | Ovarian |
| NRG-GY008 |
A Phase II Evaluation of Copanlisib (BAY 80-6946) (IND #130822), a Selective Inhibitor of PI3KCA, in Patients with Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations |
Complete | II | Gynecologic [GY] | Uterine Corpus |
| NRG-GY009 |
A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer |
Open to Accrual | II/III | Gynecologic [GY] | Ovarian |
| NRG-GY011 |
A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Medroxyprogesterone Acetate (NSC #26386) Compared to Medroxyprogesterone Acetate Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Primary Endometrioid Adenocarcinoma of the Uterine Corpus |
Terminated | II | Gynecologic [GY] | Uterine Corpus |
| NRG-GY012 |
A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer.: A Platform Trial for Women with Recurrent or Persistent Endometrial Cancer |
Closed to Accrual | II | Gynecologic [GY] | Uterine Corpus |
| NRG-GY014 |
A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma |
Closed to Accrual & Treatment | II | Gynecologic [GY] | Ovarian |
| NRG-GY016 |
A Phase II Study of MK-3475 (Pembrolizumab) (NSC #776864) + Epacadostat (NSC #766086) in Recurrent Clear Cell Carcinoma of the Ovary |
Terminated | II | Gynecologic [GY] | Ovarian |
| NRG-GY017 |
Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer |
Terminated | I | Gynecologic [GY] | Cervix |
| NRG-GY018 |
A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer |
Closed to Accrual & Treatment | III | Gynecologic [GY] | Uterine Corpus |
| NRG-GY019 |
A 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 |
Closed to Accrual | III | Gynecologic [GY] | Ovarian |
| NRG-GY020 |
A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer |
Closed to Accrual & Treatment | III | Gynecologic [GY] | Uterine Corpus |
| NRG-GY021 |
A Phase II Randomized Trial of Olaparib Versus Olaparib Plus Tremelimumab in Platinum-Sensitive Recurrent Ovarian Cancer |
Complete | II | Gynecologic [GY] | Ovarian |
| NRG-GY022 |
Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin |
Open to Accrual | I | Gynecologic [GY] | Other |
| NRG-GY023 |
A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination with Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women with Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab |
Complete | II | Gynecologic [GY] | Ovarian |
| NRG-GY024 |
Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial |
Open to Accrual | II | Gynecologic [GY] | Cervix |
| NRG-GY025 |
A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients with Deficient Mismatch Repair System Recurrent Endometrial Carcinoma |
Open to Accrual | II | Gynecologic [GY] | Uterine Corpus |
| NRG-GY026 |
A Phase III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma |
Open to Accrual | III | Gynecologic [GY] | Uterine Corpus |
| NRG-GY027 |
Phase I/IB Safety and Pharmacodynamic Study of Neoadjuvant (NACT) Paclitaxel and Carboplatin with Ipatasertib as Initial Therapy of Ovarian Cancer PTMA 100805 |
Closed to Accrual & Treatment | I | Gynecologic [GY] | Ovarian |
| NRG-GY028 |
A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer |
Closed to Accrual | I/II | Gynecologic [GY] | Uterine Corpus |
| NRG-GY029 |
A Randomized Phase II Trial Comparing the Combination of PI3K Inhibitor Copanlisib (BAY 80-6946) and PARP Inhibitor Olaparib (AZD2281) to Standard Chemotherapy in Patients with Recurrent Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Progressed Through Prior PARP Inhibitor Therapy |
Terminated | II | Gynecologic [GY] | Ovarian |
| NRG-GY031 |
A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN003694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer |
Open to Accrual | I | Gynecologic [GY] | Uterine Corpus |
| NRG-GY032 |
A Phase II Study of Tailored Adjuvant Therapy in Pole-Mutated and p53-Wildtype/NSMP Early-Stage Endometrial Cancer (RAINBO BLUE & TAPER) |
Open to Accrual | II | Gynecologic [GY] | Uterine Corpus |
| NRG-GY033 |
A Phase II Study of Androgen Receptor (AR) Inhibition by Darolutamide in Combination with Leuprolide Acetate and Exemestane in Recurrent Adult-Type Ovarian Granulosa Cell Tumor |
Temporarily Closed to Accrual | II | Gynecologic [GY] | Ovarian |
| NRG-GY036 |
A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or Without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy |
Open to Accrual | III | Gynecologic [GY] | Ovarian |
| NRG-GY037 |
A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer |
Open to Accrual | III | Gynecologic [GY] | Cervix |
| RTOG-0724 |
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 |
Terminated | III | Gynecologic [GY] | Ovarian |
| RTOG-1203 |
A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C) |
Terminated | III | Gynecologic [GY] | Other |
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