Head & Neck Cancer Awareness Month | |
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Trial Adding Relatlimab to Immunotherapy for Recurrent or Metastatic Nasopharyngeal Cancer Activates (NRG-HN011)
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NRG-HN011 (the “REMAIN” study): A Randomized Phase II Study of Nivolumab versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment after First-line Treatment with Platinum-Gemcitabine-Nivolumab for Patients with Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)
The NRG-HN011, also known as the “REMAIN” study activated to patient accrual in January 2024. This Phase II trial will accrue patients with recurrent or metastatic nasopharyngeal cancer. Following step 1-2 registration, all trial participants will receive induction treatment with platinum-based chemotherapy, gemcitabine, and nivolumab. Following step 3 registration, trial participants without progressive disease will be stratified by age (over or under 50) and number of sites of disease involvement prior to the induction treatment. Trial participants will then be randomly assigned to receive either maintenance nivolumab or nivolumab with relatlimab (BMS-986016). The primary aim of this study is to determine if adding relatlimab (BMS-986016) to maintenance nivolumab will show a signal of improved progression-free survival in patient who do not progress following induction treatment.
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NRG-HN011 Study Team Interview
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NRG Oncology recently sat down with Dr. Dimitrios Colevas to discuss the NRG-HN011 trial testing the addition of BMS-986016 (Relatilimab) to the usual immunotherapy after initial treatment for recurrent or metastatic nasopharyngeal cancer (Study PI: Dr. Bridgette B. Y. Ma). Watch below: | |
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Trial in Development Feature: NRG-HN012
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NRG-HN012 (The “XCELSIOR” Study): Randomized Phase II/III Trial of Radiotherapy with Concurrent Xevinapant vs. Cetuximab for Locoregionally Advanced Head and Neck Cancer Patients with a Cisplatin Contraindication
The phase II/III NRG-HN012 study, also known as the “XCELSIOR” study is currently in development in the NRG Oncology head and neck cancer portfolio. When activated, this trial is expected to accrue patients with locoregionally advanced head and neck squamous cell carcinoma who have a contraindication to cisplatin treatment. Patients would be stratified then randomly assigned to receive either radiotherapy with cetuximab (standard treatment) or radiotherapy with xevinapant.
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Trial in Development Feature: NRG-HN014
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NRG-HN014: Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-Of-Care treatment For Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma
NRG-HN014 is an upcoming registrational-intent, randomized phase III trial currently in development within NRG Oncology’s head and neck portfolio. The trial will be accruing patients with resectable stage III/IV cutaneous squamous cell carcinoma, stratifying them by immunosuppression and advanced nodal disease, then randomizing patients to either receive standard of care surgery with adjuvant radiotherapy or the experimental treatment arm.
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Protocol Support Committee (PSC) Column | |
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Lost in the Shuffle: Navigating Patient Follow-up in Clinical Trials
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Written by Mark Fischer BS, CCRP, Quality Assurance Monitor, University of New Mexico Comprehensive Cancer Center, New Mexico MU-NCORP
As clinical research professionals we all take immense pride in our dedication to our patients who agree to participate and partner with us in clinical trials. We often develop a strong relationship with each of our patients throughout the trial process. These relationships not only help improve patient safety but also may increase patient satisfaction with their care.
Navigating cancer care within a clinical trial is a complex and challenging endeavor for many patients. Patients may feel overwhelmed and lost due to the high demands of their care schedule. Participating in a clinical trial may contribute to these feelings.
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National Cancer Prevention & Early Detection Month | |
FORTE enrolled its 1300th participant on March 8, 2024, exactly one month after accruing its 1200th! We are also well on our way to 1400 participants! | | | |
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FORTE Workshop at #NRG2024
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The FORTE Workshop was held on Friday, February 16, where Dr. Bruner, NCORP Contact PI, championed the importance of this colorectal cancer prevention clinical trial. Topics discussed include an overview of the trial’s progress and protocol practices for FORTE success (Dr. Robert Schoen, Protocol Chair), discussing FORTE with gastroenterologists (Dr. Jeffrey Dueker, Protocol Co-Chair), FORTE enrollment at Kaiser Permanente Northern California (Jasmine Deras), and promoting FORTE within your clinical research network (Cheryl Leow, FORTE Education and Communication Specialist). The FORTE Workshop included a vibrant Q&A session, with engaged discussion with sites at different activation and accrual levels. Watch the FORTE Workshop recording to review these topics and more. | |
NRG New Protocols Under Development | |
New Protocols Under Development | |
Danielle Enserro, PhD Appointed the Associate Director of Biostatistics and Statistical Programming | |
Danielle Enserro, PhD has been promoted to Associate Director of Biostatistics and Statistical Programming at the Buffalo office of the NRG Oncology Statistics and Data Management Center (SDMC). In addition, Danielle was recently appointed to the role of Research Assistant Professor in both the Biostatistics & Bioinformatics Department at Roswell Park and the Department of Biostatistics within the School of Public Health & Health Professions at the University at Buffalo. | |
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Health Disparities Committee Symposium | |
The NRG Oncology Health Disparities Committee (HDC) will be hosting their annual symposium on Tuesday, April 16, 2024; 3-4:30pm ET. The focus of this year’s symposium will be “Aligning Clinical Trial Development with an Aging Population: Challenges and Opportunities for Older Adults with Cancer.” Refer to the agenda or the flyer for details. Please register in advance for this webinar. After registering, you will receive an email with the webinar link. | |
PCOR Committee PRO Primer Education Session at #NRG2024 Now Available on the NRG Website | |
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At the NRG Oncology Winter Meeting on February 15, 2024, the Patient Centered Outcomes Research (PCOR) Committee offered an educational session, the PCOR PRO Primer, for NRG investigators interested in learning about the basics of how to design patient reported outcomes (PROs) components for NRG trials and the responsibilities of a PRO Co-Chair.
This educational session was designed to broaden the PRO knowledge among NRG investigators. Some of the topics that were covered in this session included how to select appropriate PRO measures for each trial; how to design hypothesis-testing PRO components for a trial; the approval process for PRO components; and basic statistical considerations.
The PRO Primer session recording is now available on the NRG website under the NRG Winter 2024 Meeting page. Thank you to Dr. Ben Movsas, Dr. Ron Chen, and Dr. Stephanie Pugh for leading this PRO educational session.
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Dr. Wolmark receives American Surgical Association Medallion for Advancement of Surgical Care | |
Norman Wolmark, MD, FACS, FRCSC, Chairman of the NSABP Foundation, Inc., and Group Chair and Contact Principal Investigator of NRG Oncology, was awarded the 2024 American Surgical Association Medallion for Advancement of Surgical Care on April 4, 2024, at the American Surgical Association’s 144th Annual Meeting in Washington, D.C. | |
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The Medallion for Advancement of Surgical Care recognizes individuals who have made innovative and lasting contributions to the advancement of the care of surgical patients, in any aspect of clinical surgery or surgical education and mentorship, which truly established new benchmarks or paradigms. Dr. Wolmark has spent decades conducting groundbreaking research and clinical trials in the treatment of breast and bowel cancers. He joins a list of distinguished honorees who have received this award.
Established in 1880, the American Surgical Association is the oldest and most prestigious surgical association in the United States.
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NRG Oncology Research in 6 Plenary Presentations at SGO2024 | |
The Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer was held March 16-18, 2024 in San Diego, California. Six NRG Oncology studies were presented during plenary sessions at the conference including updates on NRG-GY018, NRG-GY005, GOG-0278 (2 presentations), NRG-GY014, and GOG-0258. Learn more
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PRESS RELEASE: Hypofractioned Post-Prostatectomy Radiotherapy New Acceptable Practice Standard Based on NRG Oncology Trial Findings | |
Results from the Phase III NRG Oncology NRG-GU003 clinical trial comparing hypofractioned post-prostatectomy radiotherapy (HYPORT) to conventionally fractioned post-prostatectomy radiotherapy (COPORT) determined that HYPORT was non-inferior to COPORT in terms of late gastrointestinal (GI) or genitourinary (GU) toxicity for patients primarily treated with prostatectomy for their prostate cancer. HYPORT was not associated with significantly higher patient-reported GU or GI symptoms at 1-2 years following radiotherapy, thus indicating HYPORT can be used as an acceptable new practice standard. There was greater short-term GI toxicity, mostly rectal irritation, associated with HYPORT as one would expect with the shorter regimen, but this difference resolved at 6 months following radiotherapy. These results were recently published in the JAMA Oncology. Read the press release
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PRESS RELEASE: NRG Oncology Announces New Leadership of Cancer Prevention & Control Committee | |
NRG Oncology, a National Cancer Institute (NCI) National Clinical Trials Network (NCTN) group focused on improving outcomes for adults with cancer through multi-center clinical research, recently announced a new Chair and Vice Chair of the organization’s Cancer Prevention and Control (CPC) Committee. Read the press release
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Information coming soon for the NRG Summer 2024 Meeting. Keep checking the NRG website, newsletters, email broadcasts, and social media for updates as they become available.
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