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Spots Global Cancer Trial Database for Study of Durvalumab (MEDI4736) After Chemo-Radiation for Microsatellite Stable Stage II-IV Rectal Cancer

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Trial Identification

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

Conditions

Rectal Cancer

Interventions

durvalumab

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Norman Wolmark, MD

Affiliation: NSABP Foundation Inc

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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