Head & Neck Cancer Awareness Month

Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naïve, Unresectable HER2-positive Salivary Gland Cancer (NRG-HN010)

Written by NRG-HN010 Principal Investigator, Alan Ho, MD

Salivary gland cancers (SGCs) are rare tumors that constitute ~5% of head and neck malignancies, representing >20 different histologic types. These orphan diseases are understudied and lack effective systemic therapy options. One of the most promising therapeutic targets for SGCs is the overexpression and/or amplification of the Her2/neu gene (“Her2+”). Over a third of salivary duct carcinomas are Her2+, as well as lesser percentages of adenocarcinomas, ex-pleomorphic carcinomas, mucoepidermoid carcinomas and other histologies. Two single-arm phase II trials which combined enrolled 100 Her2+ SGC patients in Asia (Japan and South Korea) observed that the combination of docetaxel and the Her2-directed antibody trastuzumab can produce a high rate of response (67-70%) and progression-free survival of ~8-9 months. This is now considered the most widely accepted standard therapy for this situation. Smaller prospective cohorts have also demonstrated intriguing signals of activity with other Her2-directed antibodies and Her2 antibody-drug conjugates. 

NRG Oncology and RTOG Foundation Integrated Efforts in the NRG Head and Neck Cancer Committee

Written by Stuart Wong, MD

The NRG Oncology Head and Neck Committee has a tradition of over half a century of pioneering leadership in scientific innovation. The very earliest trials from this committee, under the legacy organization RTOG, were conducted in the same era as the first lunar missions. Looking back, these seminal head and neck trials conveyed a similar spirit as the Apollo missions of exploration, excitement, and trepidation. The earliest of these investigations tested groundbreaking experimental concepts such as neoadjuvant therapy, concurrent therapy, and altered fractionated radiation. In the subsequent decades, many practice changing head and neck trials have been published by this group. These efforts were led by multi-disciplinary teams of investigators, many who were giants in their respective fields, and supported by dedicated staff, some of whom have spanned these eras. Prior leaders of the NRG (RTOG) Head and Neck Committee include Victor Marcial (a founder of RTOG), Karen Fu, Kian Ang, and Quynh Le. 

Cancer Control Month

Cancer Control Month is observed every year in April and prevention is the goal. At NRG Oncology, we aim to promote awareness for early screening for cancer to ensure early detection. The NCI’s website is a great resource for learning about cancer screenings.



PI Perspective: The Journey of NRG-GY018

Written by NRG-GY018 Principal Investigator, Ramez Eskander, MD

Video Interview Feature

NRG-CC010 Interview with Dr. Tanner

NRG-CC010, is a phase III trial of the impact of SLN mapping on patient-reported lower extremity limb dysfunction in endometrial cancer. We talked with Dr. Edward Tanner at #NRG2023 in Orlando to discuss this study further. 

Watch the full interview

NRG Health Equity Fellowship Program News

WVOCA Donates Additional Funds to the NRG Oncology Health Equity Fellowship Program

This generous $25,000 donation is delivered on top of WVOCA’s $38,000 donation for the NRG Health Equity Fellowship in April 2022. 

NRG Study News and New Protocols Under Development

Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone-Receptor Positive Metastatic Breast Cancer (EAY191-N2, A ComboMATCH Treatment Trial)

EAY191-N2 (ComboMATCH): Phase II Trial of Fulvestrant and Binimetinib in Patients with Hormone Receptor-Positive Metastatic Breast Cancer with a Frameshift or Nonsense Mutation or Genomic Deletion in NF1

The EAY191-N2 clinical study, part of the ComboMATCH precision medicine initiative, is open for patients who have hormone receptor-positive (HR+) breast cancer with NF1 Nonsense or Frameshift mutation. Patients will be enrolled into two different cohorts. Cohort 1 is testing the combination of fulvestrant and binimetinib in HR+ patients who have never received fulvestrant (fulvestrant-naïve). Cohort 2 is assessing the addition of binimetinib to fulvestrant for patients who have previously received fulvestrant (fulvestrant-exposed) and their disease progressed.

Comparing Selumetinib and Olaparib to Selumetinib Alone for Ovarian and Endometrial Cancers with RAS Pathway Mutations (EAY191-N4, A ComboMATCH Treatment Trial)

EAY191-N4 (ComboMATCH): A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients with Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers

The EAY191-N4 clinical study, part of the ComboMATCH precision medicine initiative, is open for women who have recurrent or persistent ovarian and endometrial with a RAS pathway mutation, including activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, and MEK2, or inactivating mutations in NF1. The trial will be comparing the combination of the MEK inhibitor Selumetinib and the PARP inhibitor Olaparib to Selumetinib alone for this patient population. The study will be occurring in two different cohorts. Cohort 1 will consist of patients with ovarian cancer and Cohort 2 will include patients with endometrial cancer. 

NRG-BR008/HERO Patient Webpage Activation



New Protocols Under Development

FORTE Study Update

FORTE at #NRG2023

The NRG Winter Meeting was held in-person and virtually in sunny Orlando at the end of January 2023, where the FORTE study was represented by NRG Oncology staff, study leadership, and research and medical professionals from various sites.

The FORTE Workshop was held on Friday, January 27, where Emeritus Deputy Chair of NRG Oncology, D. Lawrence Wickerham, MD, introduced the importance of the FORTE clinical trial to attendees. Topics discussed include an overview of the trial (Dr. Jeffrey Dueker, Protocol Co-Chair), a gastroenterologist perspective of FORTE (Dr. Furkan Ertem), strategies for recruitment, (Dr. Robert Schoen, Protocol Chair), and available resources targeted at gastroenterology practices (Cheryl Leow, FORTE Education and Communication Specialist). The guest coordinator panel (Jamie Saunders, Maine Health; Jodi Geer, Metro-Minnesota NCORP; Nicola Thornley, Ralph H. Johnson VA) also answered questions about the conduct of NRG-CC005 at each of their sites. Watch the FORTE Workshop recording to review these topics and more. 

NRG Protocol Support Committee (PSC) Column

Show Me the Money

Written by: Erin McCaig RN, BSN from Cancer Research for the Ozarks 

Are you collecting your Federal Funds?

Did you know many of the studies you are currently working on have approved additional NCI funding? There is no CTSU or Oncology Patient Enrollment Network (OPEN) steps needed to trigger these funds. To determine if additional funding is available, simply look for the dollar sign icon next to the protocol number in the OPEN history tab.  

SGO2023 Recap

Late-Breaking Results of NRG-GY018 Presented at SGO 2023: Study Demonstrates Improved PFS Outcomes with the Addition of Pembrolizumab to Chemotherapy for Women with Advanced or Recurrent Endometrial Cancer

Protocol-specified first interim analysis results from the Phase III NRG-GY018 clinical trial comparing pembrolizumab combined with standard of care chemotherapy followed by maintenance pembrolizumab to placebo combined with chemotherapy followed by placebo indicated that patients with stage III-IV or recurrent endometrial cancer who received pembrolizumab exhibited improved progression-free survival outcomes. These findings were presented as a late-breaking abstract at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer and are also simultaneously being published in the New England Journal of Medicine. Read the Press Release

Study Identifies Two Promising Molecular Targets for Drug Development in Recurrent and Metastatic Cervical Cancer

NRG Oncology GOG-0240 is the phase 3 randomized trial which demonstrated that the incorporation of bevacizumab with chemotherapy resulted in a statistically significant and clinically meaningful survival benefit for women with recurrent and metastatic cervical carcinoma (NCT00803062). GOG-0240 was a proof of concept in anti-angiogenesis therapy and a proof of principle in supportive care and led directly to an indication for bevacizumab in this disease in over 60 countries. Whole genome sequencing and whole exome sequencing of tumor samples obtained in GOG-0240 suggest that ARID1A and PIK3CA could represent potential targets for drug development in the recurrent/metastatic cervical cancer space. Read the Press Release

The Utilization of Atezolizumab as a Primer for Chemoradiation Results in Promising Immune System Alterations for Women with Locally Advanced Cervical Cancer

Locally advanced cervical cancer remains an area of high therapeutic need, with recent trials failing to demonstrate evidence of benefit from adjuvant chemotherapy or immune checkpoint blockade administered concurrent with chemoradiation. Results from the NRG-GY017 randomized trial comparing the anti-PD-L1 inhibitor atezolizumab before and concurrent with chemoradiation (CRT) indicated favorable outcomes for 2-year disease-free survival (DFS) and demonstrated evidence of improved immunogenicity with neoadjuvant atezolizumab in patients with locally advanced cervical cancer. These findings were presented during the Plenary Session at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer and the abstract was the recipient of the SGO 2023 Presidential Award. Read the Press Release

The Addition of Gemcitabine with Cisplatin and Intensity-Modulated Radiation Therapy Improves Outcomes for Women with Locally Advanced Vulvar Cancer

Results from the NRG Oncology Phase II NRG-GOG-0279 clinical study indicate that women with locally advanced squamous cell carcinoma of the vulva who received gemcitabine concurrently with cisplatin and intensity-modulated radiation therapy (IMRT) exhibited increased rate of pathologic complete responses (pCR). This is also the first clinical trial to standardize IMRT. These findings were presented during the Plenary Session at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer. Read the Press Release

NRG Press

NRG Oncology Combined Trial Long-Term Results Indicate that Pathologic Complete Response is Prognostic of Outcomes for Soft Tissue Sarcoma Patients