A Spotlight on Gynecologic Cancer Trials at NRG Oncology

09/16/2026

Gynecologic Cancer Awareness Month and Ovarian Cancer Awareness Month provide important opportunities to highlight the vital role of clinical research in improving outcomes for people affected by gynecologic cancers. Clinical research drives progress by helping researchers identify earlier and more accurate approaches to detection, develop innovative treatments, understand cancer risk factors, and advance personalized care. For ovarian cancer, where symptoms can be subtle and effective early-detection strategies remain an important area of research, continued investment in clinical studies is especially critical. Raising awareness about clinical research can empower patients and communities to learn about available studies, consider participation when appropriate, and recognize that every research contribution can help shape better prevention, diagnosis, treatment, and quality of life for future generations. Below, we feature multiple NRG Oncology trials in this space that are currently enrolling:

 

*NEW TRIAL* NRG-GY038

NRG Oncology opened the NRG-GY038 clinical trial earlier this month for patients with platinum-sensitive ovarian cancer that has progressed on prior maintenance PARP inhibitor therapy. This Phase II trial will enroll patients with recurrent platinum sensitive high grade serous or endometrioid ovarian, fallopian tube or primary peritoneal cancers and will stratify them by BRCA 1/2 mutation or BRCA 1/2 wildtype and homologous recombination deficiency test positive (HRD+) tumors as well as platinum free intervals of 6-12 months or over 12 months. Following stratification, patients will be randomized 1:1 to receive either standard of care carboplatin chemotherapy with pegylated liposomal doxorubicin (PLD) and Bevacizumab or the antibody-drug conjugate sacituzumab govitecan-hziy (SG) with Bevacizumab. The primary objective of this study is to compare clinical activity with regards to progression-free survival between the treatment arms.

“This study addresses a critical unmet need in these patients with progression on first-line PARPi maintenance, a population in whom subsequent platinum therapy appears less effective. By evaluating sacituzumab govitecan plus bevacizumab against the current standard of care, this study seeks to determine whether targeting the widely expressed Trop2 protein can provide a more effective treatment option for patients with limited therapeutic alternatives,” stated Rebecca Porter, MD, PhD, of the Dana-Farber Cancer Institute and the Principal Investigator of the NRG-GY038 study.

In addition to progression-free survival, this trial will also assess overall response rates, duration of response, and overall survival between treatment arms.

 

NRG-GY035

The currently enrolling NRG-GY035 Phase III trial is comparing three different treatment regimens for patients with pMMR, TP53 mutated, advanced or recurrent endometrial cancer. This study will compare the standard of care carboplatin, paclitaxel, and pembrolizumab with or without bevacizumab as well as the combination of carboplatin, paclitaxel, and bevacizumab (without pembrolizumab).

“This study has the potential to establish a more effective treatment strategy for high-risk, pMMR/TP53-mutated endometrial cancer by determining whether the addition of bevacizumab to pembrolizumab and chemotherapy can meaningfully extend progression-free and overall survival, potentially redefining the standard of care for this high-need population,” stated Amanda Nickles Fader, MD, at the Johns Hopkins University Sidney Kimmel Cancer Center and the Principal Investigator of the NRG-GY035 trial.

Patients enrolled into this study will be stratified by disease status and prior adjuvant chemotherapy and then will be randomly assigned 1:1:1 to one of the three treatment arms. In addition to progression-free survival, this study will also be looking at secondary objectives including overall survival, toxicity from treatment combinations, and anti-tumor activity via objective response rate.

The NRG Oncology Podcast featured Dr. Fader discussing NRG-GY035 on a special episode for Uterine Cancer Month alongside Patient Advocate, Anna Wilson, reflecting on her cancer diagnosis, and Dr. Aghajanian discussing NRG’s involvement in uterine cancer research. Find this episode and more at www.NRGOncology.org/Podcast

 

NRG-GY036 

The NRG-GY036 Phase III trial will be comparing one year versus two years of maintenance olaparib with or without bevacizumab in patients with BRCA 1/2 mutated or homologous recombination deficient (HRD+) ovarian cancer following response to first line platinum-based chemotherapy. Patients enrolled in this study will be stratified by BRCA deleterious alteration versus BRCA wildtype and HRD+, by physician’s choice of bevacizumab use, and by response to platinum-based therapy prior to randomization. The primary objective of this study is comparing progression-free survival between treatment arms.

“If one year of olaparib is shown to be as effective as two years, this study could establish a new standard of care that reduces treatment burden and long-term toxicity while preserving survival benefits. The findings could also help personalize maintenance therapy by identifying which patients may safely benefit from de-escalation and clarify the added value of bevacizumab,” stated Ying Liu, MD, at Memorial Sloan Kettering Cancer Center and the Principal Investigator of the NRG-GY036 trial.

In addition to progression-free survival, the study will look at secondary objectives including overall survival and toxicity.

The NRG Oncology Podcast recently featured the Dr. Liu discussing NRG-GY036 on September 4th in honor of Wear Teal Day. You can listen to this podcast and other episodes at www.NRGOncology.org/Podcast

 

NRG GY037

The NRG-GY037 study is an active, phase III trial evaluating neoadjuvant pembrolizumab with carboplatin/paclitaxel followed by chemoradiation plus pembrolizumab versus chemoradiation with concurrent and adjuvant pembrolizumab for patients with high-risk, locally advanced cervical cancer. This study builds on the practice-changing results of KEYNOTE-A18, aiming to optimize sequencing and integration of immunotherapy with definitive chemoradiation. Patients enrolled in NRG-GY037 will be stratified by FIGO 2018 stage and presence or absence of para-aortic lymph nodes. Following stratification, patients will be randomized 1:1 to either the control arm of cisplatin and external beam radiation therapy (EBRT) followed by brachytherapy and pembrolizumab with maintenance pembrolizumab or carboplatin and paclitaxel with pembrolizumab followed by cisplatin and EBRT followed by brachytherapy and pembrolizumab with maintenance pembrolizumab.

“This study has the potential to reshape treatment for locally advanced cervical cancer by combining immunotherapy and chemotherapy earlier in care. By improving outcomes and using biomarkers such as PD-L1 and ctDNA to guide treatment, it could advance more personalized and effective strategies for patients at high risk of relapse,” stated Jyoti Mayadev, MD, at the University of California San Diego and the Principal Investigator of the NRG-GY037 study.

The primary objective of this study is to determine if immunotherapy and chemotherapy prior to concurrent chemoradiation therapy with immunotherapy improves progression free survival compared to the standard of care. Additionally, this study has several secondary aims including overall survival, toxicity, and assessing the prognostic and predictive value of the integrated biomarkers.

NRG Communications interviewed Dr. Mayadev regarding the NRG-GY037 study. Watch the study overview interview here: https://youtu.be/LEaElA7KtxE

 

Please consider opening these important studies at your sites and sharing them with eligible patients.

 

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