Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03712943
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Regorafenib — DRUG
    Regorafenib orally 80 mg daily for 21 days (3 weeks on, 1 week off).
  • Nivolumab — DRUG
    Nivolumab 240 mg administered intravenously every 2 weeks.

Study Details

The main purpose of this study is to test the safety, tolerable side effects, and determine the highest tolerable dose of the combination of Regorafenib and Nivolumab. Researchers want to find out if this combination of Regorafenib and Nivolumab can help people with metastatic colorectal cancer with mismatch repair (MMR) proficiency.

Key Dates

Start date
Oct 23, 2018
Status verified
Feb 2026
Primary completion
Sep 1, 2021
Completion
Jan 18, 2024

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Regorafenib and Nivolumab Combination - Escalation
    Dose Escalation: To find the dose of regorafenib that can be safely given with nivolumab in patients with advanced, refractory colorectal cancers.
  • Experimental: Regorafenib and Nivolumab Combination - Expansion
    Dose Expansion: To find the effect on tumor of the combination of regorafenib and nivolumab.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

Related Studies