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

Part of paid clinical trials in Guilford, Connecticut.

Sponsor
NSABP Foundation Inc
Study ID
NCT03102047
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • durvalumab — DRUG
    Within 3-7 days after completion of chemoradiation, patients will receive durvalumab (750 mg IV infusion) every 2 weeks for 4 doses on Day 1(Dose 1), Day 15 (Dose 2), Day 29 (Dose 3), and Day 43 (Dose 4)

Study Details

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.

Key Dates

Start date
May 14, 2018
Status verified
Apr 2022
Primary completion
Feb 22, 2021
Completion
Dec 30, 2021

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: durvalumab
    IV infusion once every 2 weeks for 4 total doses

Primary Outcome Measure

Median modified Neoadjuvant Rectal (mNAR) Score [ Time Frame: From the beginning of the study to time of surgical resection, assessed over an estimated 12 weeks ]

Locations (43)

FacilityCityStateZIPSite coordinators
Smilow Cancer Hospital Care Center at GuilfordGuilfordConnecticut06437-
Smilow Cancer Hospital Care Center at YaleNew HavenConnecticut06510-
Yale University, Yale Cancer CenterNew HavenConnecticut06520-
Smilow Cancer Hospital Care Center at North HavenNorth HavenConnecticut06473-
Smilow Cancer Hospital Care Center at TrumbullTrumbullConnecticut06477-
Smilow Cancer Hospital at Lawrence + Memorial Cancer CenterWaterfordConnecticut06385-
University of FloridaGainesvilleFlorida32610-
Cancer Care Specialists of Central IllinoisDecaturIllinois62526-
Cancer Care Specialists of Central Illinois-Crossroads Cancer CenterEffinghamIllinois62401-
Cancer Care Specialists of Central Illinois-SwanseaSwanseaIllinois62226-
University of MichiganAnn ArborMichigan48109-
University of Michigan OncologyAnn ArborMichigan48109-
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Wake Forest Medical CenterWinston-SalemNorth Carolina27157-
Strecker Cancer CenterBelpreOhio45714-
Adena Regional Medical CenterChillicotheOhio45601-
Columbus NCORPColumbusOhio43215-
Doctors HospitalColumbusOhio43228-
Grant Medical CenterColumbusOhio43215-
Columbus Oncology and Hematology Associates, Inc.DelawareOhio43015-
Delaware Health Center Grady Cancer CenterDelawareOhio43015-
Marietta Memorial HospitalMariettaOhio45750-
Marion General HospitalMarionOhio43302-
The Mark H. Sangmeister CenterMarionOhio43302-
Knox Community HospitalMount VernonOhio43050-
Licking Memorial HospitalNewarkOhio43055-
Southern Ohio Medical CenterPort ClintonOhio45662-
Genesis Health Care CenterZanesvilleOhio43701-
UPMC Hillman Cancer at Upper St ClairBethel ParkPennsylvania15102-
UPMC Hillman Cancer Center at Mt. ViewGreensburgPennsylvania15601-
AHN Cancer Institute at JeffersonJefferson HillsPennsylvania15025-
Forbes Regional HospitalMonroevillePennsylvania15146-
UPMC Hillman Cancer Center at MonroevilleMonroevillePennsylvania15146-
Allegheny General HospitalPittsburghPennsylvania15212-
UPCI Hillman/ShadysidePittsburghPennsylvania15232-
UPMC Cancer Center at Passavant OHAPittsburghPennsylvania15237-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
UPMC Hillman Cancer Center at Passvant HOAPittsburghPennsylvania15237-
Western Pennsylvania Hospital dba West Penn HospitalPittsburghPennsylvania15224-
WPAON/Medical Center ClinicPittsburghPennsylvania15212-
UPMC Hillman Cancer Center at WashingtonWashingtonPennsylvania15301-
West Virginia UniversityMorgantownWest Virginia26506-
West Virginia University MedicineMorgantownWest Virginia26506-

Find similar trials in Guilford, CT

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Smilow Cancer Hospital Care Center at Guilford· Guilford, CTSmilow Cancer Hospital Care Center at Yale· New Haven, CTYale University, Yale Cancer Center· New Haven, CTSmilow Cancer Hospital Care Center at North Haven· North Haven, CTSmilow Cancer Hospital Care Center at Trumbull· Trumbull, CTSmilow Cancer Hospital at Lawrence + Memorial Cancer Center· Waterford, CT

Related Studies