Study of Durvalumab and Tremelimumab After Radiation for Microsatellite Stable Metastatic Colorectal Cancer Progressing on Chemotherapy

Part of paid clinical trials in Duarte, California.

Sponsor
NSABP Foundation Inc
Study ID
NCT03007407
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • durvalumab — DRUG
    Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive durvalumab (1500 mg IV infusion) on Day 1 for 4 cycles (in combination with tremelimumab). Beginning with Cycle 5 through Cycle 12, patients will receive durvalumab alone (1500 mg/IV infusion) on Day 1 of each 28 day cycle.
  • Tremelimumab — DRUG
    Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive tremelimumab (75 mg IV infusion) on Day 1 for 4 cycles (in combination with durvalumab).

Study Details

This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune system to destroy the cancer cells. In order to learn more about certain characteristics of colorectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, fresh tumor samples from an area where the cancer has spread, and blood samples.

Key Dates

Start date
Jul 31, 2017
Status verified
Nov 2022
Primary completion
Apr 18, 2019
Completion
Aug 9, 2019

Study Design

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

Arms

  • Experimental: durvalumab and tremelimumab

Primary Outcome Measure

Overall Objective Response Rate (ORR) of Dual Immune Checkpoint Blockade by RECIST 1.1 [ Time Frame: Through treatment, up to 1.3 years ]

Locations (18)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Smilow Cancer Hospital at Yale-New HavenNew HavenConnecticut06510-
Smilow Cancer Hospital Care Center at North HavenNorth HavenConnecticut06473-
UF Health Davis Cancer Pavilion and Shands Med PlazaGainesvilleFlorida32608-
UF Health Shands Cancer HospitalGainesvilleFlorida32608-
UF Health Shands HospitalGainesvilleFlorida32610-
University of FloridaGainesvilleFlorida32610-
University of Florida Health Cancer Center at Orlando HealthOrlandoFlorida32806-
Centralia Oncology ClinicCentraliaIllinois62801-
Cancer Care Specialists of Central IllinoisDecaturIllinois62526-
Cancer Care Specialists of Central Illinois/Crossroads Cancer CenterEffinghamIllinois62401-
Cancer Care Specialists of Central Illinois-SwanseaSwanseaIllinois62226-
Trinity Health MichiganAnn ArborMichigan48106-
University of MichiganAnn ArborMichigan48109-
St. Joseph Mercy-BrightonBrightonMichigan48114-
St. Joseph Mercy-CantonCantonMichigan48188-
St Joseph Mercy-ChelseaChelseaMichigan48118-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CASmilow Cancer Hospital at Yale-New Haven· New Haven, CTSmilow Cancer Hospital Care Center at North Haven· North Haven, CTUF Health Davis Cancer Pavilion and Shands Med Plaza· Gainesville, FLUF Health Shands Cancer Hospital· Gainesville, FLUF Health Shands Hospital· Gainesville, FL

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