Gynecologic Cancer Committee

Purpose
The NRG Oncology Gynecologic Cancer Committee’s purpose is to oversee the Gynecologic Subcommittees which aim to improve the lives of patients with Gynecologic Cancers by designing and conducting practice-changing multi-institutional clinical trials and translational research. These subcommittees include Cervix/Vulvar, Ovarian, Rare Tumor, and Uterine Corpus, and focus on developing and testing innovative advanced surgical, radiation oncology, and systemic (including chemotherapy and other targeted/biologic therapies) technologies for patients with gynecologic malignancies. Additionally, this committee is committed to identifying and rectifying disparities in patient outcomes within this population.

The goals of this committee include developing national and international priorities, goals, and initiatives for the management of gynecologic cancers; developing and managing currently active and developing NRG clinical trials on the prevention, diagnosis, and treatment of gynecologic cancers; and, fostering the advancement of promising therapeutics in development and exploring potential translational research and biomarker development for incorporation into future clinical trials. This committee strives to develop and implement standardized procedures needed to design and conduct a research protocol within NRG while identifying potential barriers, and potential solutions to improve enrollment to NRG clinical trials in gynecologic cancers, including fostering international collaboration. This committee meets monthly, including twice per year in-person.

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

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 

 

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Study Title Status Phase Disease Category Disease Site
NRG-GY007A 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
Closed to AccrualI/IIGynecologic [GY]Ovarian
GOG-0184A 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 CARCINOMATerminatedIIIGynecologic [GY]Uterine Corpus
NRG-GY032A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-wildtype/NSMP Early-Stage Endometrial Cancer (RAINBO BLUE & TAPER)

Open to AccrualIIGynecologic [GY]Uterine Corpus
EAY191-N5Molecular Analysis for Combination Therapy Choice (ComboMATCH) 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 AccrualIIGynecologic [GY]Multiple
NRG-GY033A Phase II Study of Androgen Receptor (AR) Inhibition by Darolutamide in combination with Leuprolide Acetate and Exemestane in Recurrent Adult-Type Ovarian Granulosa Cell Tumors
Temporarily Closed to AccrualIIGynecologic [GY]Ovarian
NRG-GY031A Phase IB Study Of Combination Atr (M1774) And Bet Inhibition (Zen003694) To Exploit Arid1a Loss In Recurrent Ovarian And Endometrial Cancer

Open to AccrualI/IIGynecologic [GY]Uterine Corpus
EAY191-N4 Molecular Analysis for Combination Therapy Choice (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 - A ComboMATCH Treatment Trial

Open to AccrualIIGynecologic [GY]Multiple
NRG-GY028A Phase IB and Randomized Phase II trial of Megestrol Acetate with or without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

Open to AccrualI/IIGynecologic [GY]Uterine Corpus
NRG-CC010A Phase III Trial of the Impact of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer

Open to AccrualIIIGynecologic [GY]Uterine Corpus
NRG-GY026A Phase II/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 AccrualII/IIIGynecologic [GY]Uterine Corpus
NRG-GY029A 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

Closed to AccrualIIGynecologic [GY]Ovarian
NRG-GY027NRG-GY027: PHASE I/IB SAFETY AND PHARMACODYNAMIC STUDY OF NEOADJUVANT (NACT) PACLITAXEL AND CARBOPLATIN WITH IPATASERTIB AS INITIAL THERAPY OF OVARIAN CANCER PTMA 100805

Open to AccrualIGynecologic [GY]Ovarian
NRG-GY025NRG-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 AccrualIIGynecologic [GY]Uterine Corpus
NRG-GY024Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment TrialOpen to AccrualIIGynecologic [GY]Cervix
NRG-GY023A 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 BevacizumabClosed to AccrualIIGynecologic [GY]Ovarian
GOG-0268A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: 683864, IND #61010) in Combination with Carboplatin and Paclitaxel followed by Temsirolimus Consolidation as First-line Therapy in the Treatment of Clear Cell Carcinoma of the Ovary.Closed to AccrualIIGynecologic [GY]Ovarian
GOG-0214Phase 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)

TerminatedIIGynecologic [GY]Ovarian
GOG-0207A Randomized Double-Blind Phase II Trial of Celecoxib, A COX-2 Inhibitor, In The Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3TerminatedIIGynecologic [GY]Cervix
GOG-0199Prospective Study of Risk-Reducing Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer
TerminatedIGynecologic [GY]Ovarian
GOG-0210A Molecular Staging Study of Endometrial CarcinomaTerminatedIGynecologic [GY]Uterine Corpus
NRG-GY020A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed, Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial CancerClosed to AccrualIIIGynecologic [GY]Uterine Corpus
NRG-GY021A Phase II Randomized Trial of Olaparib versus Olaparib plus Tremelimumab in Platinum-Sensitive Recurrent Ovarian CancerClosed to AccrualIIGynecologic [GY]Ovarian
NRG-GY022Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinOpen to AccrualIGynecologic [GY]Other
NRG-GY019A 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 PeritoneumOpen to AccrualIIIGynecologic [GY]Ovarian
GOG-0274 RTOG 1174A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone: THE OUTBACK TRIALClosed to AccrualIIIGynecologic [GY]Cervix
NRG-GY018A 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 CANCERClosed to AccrualIIIGynecologic [GY]Uterine Corpus
NRG-GY014A Phase II Study of Tazemetostat (EPZ-6438) (IND # 138671) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial AdenocarcinomaClosed to AccrualIIGynecologic [GY]Ovarian
GOG-0237Comparative 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 AccrualIGynecologic [GY]Cervix
GOG-0238A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-only Recurrence of Carcinoma of the Uterine CorpusTerminatedIIGynecologic [GY]Uterine Corpus
NRG-GY012A 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 CancerClosed to AccrualIIGynecologic [GY]Uterine Corpus
GOG-9923A Phase I Study of Carboplatin/Paclitaxel/CTEP-Supplied Bevacizumab(NSC #704865, IND #7921)and CTEP-Supplied Agent ABT-888(NSC #737664,IND# 77840)in Newly Diagnosed Patients with Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary PeritCancerTerminatedIGynecologic [GY]Ovarian
GOG-0277A 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 leiomyosarcomaTerminatedIIIGynecologic [GY]Uterine Corpus
GOG-0260A 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 (IND 110072) (NCT# 00888615).TerminatedIIGynecologic [GY]Ovarian
GOG-0186KA 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 CancerTerminatedIIGynecologic [GY]Ovarian
NRG-GY016A Phase II Study of MK-3475 (Pembrolizumab) (NSC #776864) + Epacadostat (NSC #766086) in Recurrent Clear Cell Carcinoma of the OvaryTerminatedIIGynecologic [GY]Ovarian
GOG-9926A 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 Para-Aortic Lymph NodesTerminatedIGynecologic [GY]Cervix
NRG-GY001A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women with Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or PeritoneumTerminatedIIGynecologic [GY]Ovarian
GOG-0213A Phase III Randomized Controlled Clinical Trial Of Carboplatin and Paclitaxel or  Gemcitabine) Alone or in Combination with Bevacizumab (NSC #704865, IND #113912) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrenovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865, IND #113912) Closed to AccrualIIIGynecologic [GY]Ovarian
NRG-GY006A 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 CancerClosed to AccrualIIIGynecologic [GY]Cervix
NRG-GY005A 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 AccrualII/IIIGynecologic [GY]Ovarian
NRG-GY004A 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 CancerClosed to AccrualIIIGynecologic [GY]Ovarian
GOG-0239A Phase II Trial of AZD6244 (NSC #748727, IND #77782) in Women with Recurrent Low-Grade Serous Carcinoma of the Ovary or PeritoneumTerminatedIIGynecologic [GY]Ovarian
GOG-0278Evaluation 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 (</= 2 cm) Cervical CancerClosed to AccrualI/IIGynecologic [GY]Cervix
NRG-GY017Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical CancerClosed to AccrualIGynecologic [GY]Cervix
NRG-GY003A Phase II Randomized Trial of Nivolumab with or without Ipilimumab in Patients with Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube CancerClosed to AccrualIIGynecologic [GY]Ovarian
AGCT1531A 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 TumorsOpen to AccrualIIIGynecologic [GY]Other
NRG-GY008A 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 MutationsTerminatedIIGynecologic [GY]Uterine Corpus
NRG-GY002A Phase II Evaluation of Nivolumab, a Fully Human Antibody against PD-1, in the Treatment of Persistent or Recurrent Cervical CancerTerminatedIIGynecologic [GY]Cervix
GOG-0225Can Diet and Physical Activity Modulate Ovarian or Primary Peritoneal Cancer Progression-Free Survival?Closed to AccrualIIIGynecologic [GY]Ovarian
NRG-GY009A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab (IND #134427) Versus Pegylated Liposomal Doxorubicin, CTEP-Supplied Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin and CTEP-Supplied Bevacizumab in Platinum Resistant Ovarian Cancer Closed to AccrualII/IIIGynecologic [GY]Ovarian
GOG-0186HA 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 CancerTerminatedIIGynecologic [GY]Ovarian
RTOG-1203A Randomized Phase III Study Of Standard Vs. IMRT Pelvic Radiation For Post-Operative Treatment Of Endometrial And Cervical Cancer (TIME-C)--RTOG CCOP StudyTerminatedIIIGynecologic [GY]Other
GOG-0263Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA, Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphdenectomy.Closed to AccrualIIIGynecologic [GY]Cervix
GOG-0281A 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 CancerClosed to AccrualII/IIIGynecologic [GY]Ovarian
GOG-9928A Phase I study of the safety of intraperitoneal EGEN-001 (IL-12 plasmid formulated with PEG-PEI-Cholesterol lipopolymer) administered in combination with pegylated liposomal doxorubicin (PLD) in recurrent ovarian cancer patients. The purpose of this studtermine the safety of EGEN-001 IP plus PLD treatment in platinum-recurrent ovarian cancer patients.TerminatedIGynecologic [GY]Ovarian
GOG-9924A 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 CancerTerminatedIGynecologic [GY]Ovarian
GOG-0280A Phase II Eval of the Poly(ADP-Ribose)Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888)(NSC #737644) in the tx of Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Ca in Patients who carry a germline BRCA 1 or 2 Mutation  TerminatedIIGynecologic [GY]Ovarian
NRG-GY011A 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 CorpusTerminatedIGynecologic [GY]Uterine Corpus
GOG-0286BA 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 CancerClosed to AccrualII/IIIGynecologic [GY]Uterine Corpus
RTOG-0724Phase 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 HysterectomyClosed to AccrualIIIGynecologic [GY]Ovarian
GOG-0229OA randomized phase II study with a phase I 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.TerminatedIIGynecologic [GY]Uterine Corpus

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