Philadelphia, May 26, 2016 -- Enrollment of patients in the National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) phase II precision medicine cancer trial will resume on Tuesday, May 31, 2016, at 12:00 Noon Eastern Time, the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) announced today. The trial will be available in nearly 900 medical facilities nationwide.
The trial opened to patient enrollment in August 2015 with 10 treatment arms and a goal to genetically screen 3000 patients for possible treatment in the trial. Enrollment of new patients was paused in November 2015 for a planned scientific review.
The NCI-MATCH trial will determine whether treating patients with certain drugs or drug combinations that target changes in the tumor genes will shrink the cancer, regardless of its location in the body, such as the breast, lungs, etc. Changes in tumor genes are believed to drive cancer growth.
Treatments that show promise in the NCI-MATCH trial can then advance to larger, more definitive clinical trials.
During the pause in enrollment of new patients, investigators analyzed many facets of this innovative study that ignores the specific type of cancer in favor of looking for common genetic changes across tumor types.
Based upon this analysis, several changes to the trial design are now in effect:
- The number of available treatment arms increased from 10 to 24. Each arm tests treatment for a unique gene abnormality.
- The estimate for the percentage of patients who will match to the 24 treatment arms is 23 percent--about one in four or five--to reflect the actual percentage of individuals in the initial group with matching gene abnormalities, which was lower than expected. The original estimate was that about one in every three patients might have a matching gene abnormality, based on data from other studies.
- The overall size of the trial increased from 3000 to 5000 patients for genetic screening, to include a larger number of patients given the lower-than-expected match rate.
- Physicians can now submit archived biopsy tissue samples in place of fresh tissue for genetic testing. This can occur if the biopsy samples were obtained within six months prior to enrollment on this trial and if patients have not received any intervening therapy that is considered to be targeted (e.g. against a particular target or multiple molecular targets) since the collection of the tumor sample. This can also occur in patients who received cytotoxic chemotherapy for up to four cycles, without the cancer responding to that treatment.
Expansion of Laboratory Capacity to Meet Demand
The launch of the trial last August was met with strong support by physicians, advocates, and patients, and as a result, patient registration for genetic screening was rapid from the start. Nearly 800 patients enrolled in the first three months of the trial, far surpassing the original estimate of 50 patients per month.
To address the expected return to a high pace of enrollment when the trial resumes, laboratory capacity is now in place to handle the processing of 100 patients per week.
Appropriate Patient Selection
Part of the increase in the overall screening goal to 5000 patients is the importance of selecting the right individuals for the trial. Trial leaders will strengthen communication with enrolling physicians about the importance of referring into the trial only those patients who have adequate function of major organs and are able to carry out light daily physical activities.
Patients must be able to withstand being off treatment for up to six weeks because the process of genetic testing can take up to three or four weeks to complete, starting from the time of the patient's tumor biopsy. Then, for patients who have a gene abnormality matching one of the 24 treatment arms, it can take up to two additional weeks to evaluate whether they meet the eligibility requirements for entering the specific treatment arm.
About the NCI-MATCH Trial
The NCI-MATCH trial is for patients with solid tumors or lymphomas that have progressed after standard systemic (oral or intravenous) therapy, and rare cancers for which there is no standard treatment. The study was co-developed by ECOG-ACRIN and the NCI. ECOG-ACRIN is leading the trial, and in this capacity, coordinates the genetic testing. It also supports all trial sites with training, tumor tissue collection and shipping, molecular laboratory services, trial assignments, biostatistical support, data management, auditing, quality control, and public awareness.
Several more treatment arms for the NCI-MATCH trial are in development, each one targeting a gene abnormality not in the current group of 24 treatment arms. These additional arms are expected to open to patient enrollment in coming months. The additional treatment arms may increase the estimated match rate.
ECOG-ACRIN study chair Keith T. Flaherty, MD, a medical oncologist at Massachusetts General Hospital and associate professor at Harvard Medical School, both in Boston, is available for comment.
For more information, visit http://ecog-acrin.org/nci-match-eay131.
The ECOG-ACRIN Cancer Research Group is a membership-based scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer. ECOG-ACRIN comprises nearly 1100 member institutions in the United States and around the world. Approximately 12,000 physicians, translational scientists, and associated research professionals from the member institutions are involved in Group research, which is organized into three scientific programs: Cancer Control and Outcomes, Therapeutic Studies, and Biomarker Sciences. ECOG-ACRIN is supported primarily through National Cancer Institute research grant funding, but also receives funding from private sector organizations through philanthropy and collaborations. It is headquartered in Philadelphia, Pa. For more information, visit ecog-acrin.org, call 215.789.3631, and follow the organization on Twitter: @eaonc.