Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
University of Southern California
Study ID
NCT03657641
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Regorafenib — DRUG
    Given PO

Study Details

This phase I/II studies the side effects and best dose of regorafenib when given together with pembrolizumab in treating participants with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as regorafenib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and pembrolizumab may work better at treating colorectal cancer.

Key Dates

First listed
Sep 5, 2018
Start date
Jun 21, 2019
Status verified
Jun 2026
Primary completion
Feb 27, 2023
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Treatment (pembrolizumab, regorafenib)
    Participants receive pembrolizumab IV over 30 minutes on day 1 and regorafenib PO QD on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Patients With Dose Modification Due to Toxicity [ Time Frame: At the end of Course 1 (each course is 21 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope· Duarte, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAMoffitt Cancer Center· Tampa, FL

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