From the Co-Chairs, January 2022January 26, 2022
Trial Results: Copanlisib in Patients with PIK3CA-Mutated TumorsFebruary 24, 2022
New Website, New Clinical Trial Searching
The new website ECOG-ACRIN.org offers an improved central resource for ECOG-ACRIN’s trials. Visit the Active Clinical Trials Table where you can search and sort trials by cancer type, trial ID, target patient population, keyword, and more. Each trial now has a description, eligibility criteria, locations and contacts, trial objectives and outline (interactive content from the official study record on the National Cancer Institute website cancer.gov), as well as educational/recruitment materials.
NCI-MATCH Continues to Offer Treatment Opportunities
The study chairs for this trial are Alice Chen, MD (NCI) and Keith Flaherty, MD (ECOG-ACRIN). The study co-chairs are Lyndsay Harris, MD (NCI) and Peter O'Dwyer, MD (ECOG-ACRIN).
Investigators and research staff, please continue to keep the open treatment arms top-of-mind when considering treatment options for your patients:
- Evaluating the immunotherapy combination of relatlimab and nivolumab (Arm Z1M). It is for patients whose tumors have mismatch repair deficiency and LAG-3 expression and have progressed after anti–PD-1/PD-L1 immunotherapy. Enrollment status: 0/35 patients
- Combination of the BRAF inhibitor dabrafenib and the MEK1/2 inhibitor trametinib in tumors harboring BRAF V600E or BRAF V600K mutations (Arm H). Enrollment status: 5/50 patients
"NCI-MATCH's Arm H shows promising activity outside of currently approved FDA indications," said lead researcher April K.S. Salama, MD (Duke University). “So far, the data show that BRAF/MEK combination therapy has widespread activity across multiple cancer types whose tumors harbor BRAF mutations. Therefore, we hope to identify 50 more patients for Arm H to define the broad applicability of these positive findings.”
NCI-MATCH has eliminated the need for a formal referral letter from the laboratories.
A revision in Addendum #29 helps oncologists determine more quickly whether their patients are eligible for one of the treatment subprotocols. In short, they no longer need a formal referral letter or email from the lab to enroll their patient to the trial’s Step 0 for an eligibility determination. Previously, if the lab found a match, it was required to send a formal referral to the ordering physician (either a letter or email). In some cases, the formal notification was a rate-limiting step. Now, the physician uses the laboratory sequencing result to register the patient to Step 0 for a screening assessment. After that, the rest of the eligibility determination process is the same.
The goal of eliminating the formal referral is to see an uptick in registrations to Step 0, resulting in more patients assigned to the available treatment arms.
Read the feature article on the results of Arm Z1F in this issue.
TMIST Hits Accrual Milestone
The study chair for this trial is Etta Pisano, MD (Beth Israel Deaconess Medical Center, Harvard Medical School, and the American College of Radiology).
The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is now more than halfway towards meeting its enrollment goal of 128,905 participants. Total accrual stands at 64,560 participants among 119 participating sites as of February 24, 2022.
“We must continue to invite women to take part in TMIST,” says ECOG-ACRIN group co-chair Mitchell D. Schnall, MD, PhD (University of Pennsylvania). “This trial can help us learn how to improve the process for identifying high-risk patients and utilize both digital mammography and digital breast tomosynthesis better.”
Important updates and reminders:
- Financial burden can be a barrier to TMIST participation, especially for women of color, and can be exacerbated by COVID-19. The supplemental trial EAQ201 is assessing COVID-19-related financial hardship and distress in women who decline participation in TMIST.
- A CIRB-approved TMIST video is now available
- New sites may join this trial! If your site is interested in offering this trial to your constituents, email TMIST@acr.org to discuss the study requirements, reimbursement/payment structure, and how to start the application process
- Read the quarterly site newsletter for more updates
The Cancer Letter Spotlights Edith Mitchell
In a recent issue, Cancer History Project guest editor for Black History Month Robert Winn interviewed Edith P. Mitchell, MD. Dr. Mitchell detailed her journey from living in rural Tennessee to achieving success as a cancer doctor and a brigadier general. Read the interview or listen to the podcast now. Dr. Mitchell also took part in a panel discussion for Black History Month hosted by the Cancer History Project on February 23. She and other panelists including Robert A. Winn, MD, Otis W. Brawley, MD, and John H. Stewart, MD, MBA discussed the evolution of the health equity movement.
Dr. Mitchell is co-chair of the ECOG-ACRIN Health Equity Committee. She is a clinical professor of medicine and medical oncology, director of the Center to Eliminate Cancer Disparities, and associate director of Diversity Affairs at the Sidney Kimmel Cancer Center at Thomas Jefferson University. She also serves as a member of the President’s Cancer Panel.
Read ECOG-ACRIN's profile of Dr. Mitchell in this month's issue of News from ECOG-ACRIN.
OncLive On Air® Features Melissa Simon
In a recent episode of OncLive On Air®, Melissa A. Simon, MD, MPH discusses unmet needs regarding clinical trials for underserved populations with cancer, highlights the key objectives of the ECOG-ACRIN Health Equity Committee and the US Preventive Services Task Force, and shares her advice to health care professionals in the cancer space who are working to bridge some of these disparities. Listen to the full episode.
Dr. Simon is chair of the ECOG-ACRIN Health Equity Committee. She is the vice chair for research in the Department of Obstetrics and Gynecology, director of the Institute for Public Health and Medicine – Center for Health Equity Transformation, the George H. Gardner, MD, Professor of Clinical Gynecology, and a professor of obstetrics and gynecology (general obstetrics and gynecology)/preventive medicine and medical social sciences at the Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center at Northwestern Medicine.
Psychosocial Outcomes and Health Promotion Subcommittee Leaders among Authors of NCI Cancer Moonshot’s Tobacco Cessation Publication Series
Elyse R. Park, PhD, MPH and Jamie S. Ostroff, PhD recently co-authored several articles in a series of articles published in the Journal of the National Comprehensive Cancer Network. The articles are from the Cancer Center Cessation Initiative (C3I), part of the NIH/NCI Cancer Moonshot, which focuses on integrating tobacco treatment in cancer care delivery. Among the topics:
- Involving Family and Social Support Systems
- Implementation Science of Tobacco Cessation Services
- Sustainability of Tobacco Treatment Programs
- Integrating Diversity, Equity, and Inclusion Approaches
- Introduction to the C3I Working Groups
Drs. Park and Ostroff are study co-chairs for trial EAQ171CD, Implementing a Virtual Tobacco Treatment in Community Oncology Practices: “Smoke-Free Support Study 2.0.”
Spring 2022 Group Meeting
Registration for ECOG-ACRIN’s Spring 2022 Group Meeting, Wednesday, May 4 - Friday, May 6, is expected to open in early March. We currently plan to hold this meeting in person at the Chicago Marriott Downtown Magnificent Mile. The hotel is following the City of Chicago’s latest vaccination and mask mandates. At this time, all hotel patrons age 5 and older must be fully vaccinated against COVID-19 and wear a mask to visit any communal spaces. Verification of guests’ vaccination status will be required to access these areas.
We look forward to welcoming back our industry partners for this meeting. As usual, staff from ECOG-ACRIN member institutions, ECOG-ACRIN advocates, NCI/NIH employees, and invited guests may attend.
Sessions will likely begin early in the morning on Wednesday and end by noon on Friday (subject to change).