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Brief Title: Study of Durvalumab (MEDI4736) After Chemo-Radiation for Microsatellite Stable Stage II-IV Rectal Cancer
Official Title: A Phase II Study to Assess the Activity of PD-L1 Inhibition With Durvalumab (MEDI4736) After Chemo-Radiotherapy in Patients With Stage II-IV Microsatellite Stable (MSS) Rectal Cancer
Study ID: NCT03102047
Brief Summary: This study is being done to look at the safety and response to the investigational drug durvalumab (MEDI4736) following chemo-radiation therapy for patients with MSS stage II to IV rectal cancer. Durvalumab recognizes specific proteins on the surface of cancer cells and triggers the immune system to destroy the cancer cells. The chemoRT portion of the treatment will be completed just before the course of durvalumab is initiated. In order to learn more about certain characteristics of rectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, a tissue sample from tumors removed during surgery, fresh tumor samples from an area where the cancer has recurred, and blood samples.
Detailed Description: The FR-2 study is designed as a phase II, open label, single arm study in patients with microsatellite stable (MSS) stages II-IV rectal cancer, to assess the activity of PD-L1 inhibition with durvalumab (MEDI4736) monotherapy after standard chemo-radiotherapy (chemoRT). The study's primary aim is to determine the safety and efficacy of durvalumab immediately following chemoRT in patients undergoing subsequent surgery with stage II-IV rectal cancer. One dose of durvalumab will be given every 2 weeks for four total doses beginning within 3-7 days of completing chemoRT. Surgery for all patients must occur within 8-12 weeks of the final dose of RT. Adjuvant chemotherapy after surgical recovery is at the discretion of the treating physician. During a safety run-in, the first 6 patients will be closely followed for 30 days after last dose of durvalumab without further accrual of patients. Patients will receive durvalumab (750mg IV infusion once every 2 weeks) for 4 total doses. No other concurrent anti-neoplastic medications or treatments aside from standard supportive care will be allowed during the durvalumab treatment phase. The safety run-in portion of the study will proceed to full enrollment at the proposed study therapy dose, (750 mg IV infusion every 2 weeks), if one or less dose-limiting toxicity (DLT) or significant safety concern attributable to durvalumab is identified during the observation period of the first 6 patients. If there are two or more DLTs, accrual to the study will stop with reassessment of the protocol. A total of 44 patients will be enrolled in this study for a sample size of 41 surgically evaluable patients. Required tissue and blood samples will be collected at specific time points and submitted for correlative science studies. Optional tumor and blood samples will be collected from consenting patients upon disease recurrence or progression. Given the increasing use of non-operative therapy for patients with rectal cancer who achieve a complete clinical response and in order to maximize the inclusion of patients participating in this trial, the primary endpoint was changed from NAR score to modified NAR score (mNAR). The mNAR score substitutes values from clinical staging for the pathologic T-Stage and N-Stage for those patients who don't go to surgery because of a complete clinical response and consequently have no pathology. Additionally, because of enrollment challenges related to COVID-19 pandemic and the exploratory nature of including stage IV patients, the stage IV analysis was moved to exploratory and reducing the number of patients needing to be enrolled in the study to approximately 44.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Smilow Cancer Hospital Care Center at Guilford, Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Yale, New Haven, Connecticut, United States
Yale University, Yale Cancer Center, New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at North Haven, North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Trumbull, Trumbull, Connecticut, United States
Smilow Cancer Hospital at Lawrence + Memorial Cancer Center, Waterford, Connecticut, United States
University of Florida, Gainesville, Florida, United States
Cancer Care Specialists of Central Illinois, Decatur, Illinois, United States
Cancer Care Specialists of Central Illinois-Crossroads Cancer Center, Effingham, Illinois, United States
Cancer Care Specialists of Central Illinois-Swansea, Swansea, Illinois, United States
University of Michigan Oncology, Ann Arbor, Michigan, United States
University of Michigan, Ann Arbor, Michigan, United States
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Wake Forest Medical Center, Winston-Salem, North Carolina, United States
Strecker Cancer Center, Belpre, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Columbus NCORP, Columbus, Ohio, United States
Grant Medical Center, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Columbus Oncology and Hematology Associates, Inc., Delaware, Ohio, United States
Delaware Health Center Grady Cancer Center, Delaware, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
Marion General Hospital, Marion, Ohio, United States
The Mark H. Sangmeister Center, Marion, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Southern Ohio Medical Center, Port Clinton, Ohio, United States
Genesis Health Care Center, Zanesville, Ohio, United States
UPMC Hillman Cancer at Upper St Clair, Bethel Park, Pennsylvania, United States
UPMC Hillman Cancer Center at Mt. View, Greensburg, Pennsylvania, United States
AHN Cancer Institute at Jefferson, Jefferson Hills, Pennsylvania, United States
Forbes Regional Hospital, Monroeville, Pennsylvania, United States
UPMC Hillman Cancer Center at Monroeville, Monroeville, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
WPAON/Medical Center Clinic, Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital dba West Penn Hospital, Pittsburgh, Pennsylvania, United States
UPCI Hillman/Shadyside, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at Passavant OHA, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center at Passvant HOA, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center at Washington, Washington, Pennsylvania, United States
West Virginia University Medicine, Morgantown, West Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
Name: Norman Wolmark, MD
Affiliation: NSABP Foundation Inc
Role: PRINCIPAL_INVESTIGATOR