A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Bayer
Study ID
NCT04704154
Phase
PHASE2
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Regorafenib, (Stivarga, BAY73-4506) — DRUG
    Intake orally, starting with 3x 30 mg tablets every day (once daily.) for 21 days of every 28-day cycle (21 days on, 7 days off). If the starting dose is well tolerated dose can be escalated to 120 mg (4x30 mg tablets).
  • Nivolumab (Opdivo) — DRUG
    480 mg administered on Day 1 of each treatment cycle.

Study Details

Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts. The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion). The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years. During the trial, the doctors will take pictures of the participants' tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.

Key Dates

Start date
Feb 3, 2021
Status verified
Mar 2025
Primary completion
Mar 9, 2023
Completion
Mar 29, 2024

Study Design

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

Arms

  • Experimental: Regorafenib+Nivolumab
    Parallel-cohort in adult participants with selected recurrent or metastatic tumors (HNSCC, ESCC, PDAC, BTC, and GBM/AA) who have been previously treated with one or more systemic therapy for the selected tumor indication.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope - Duarte Cancer CenterDuarteCalifornia91010-
Rocky Mountain Cancer Centers / Aurora, COAuroraColorado80012-
Moffitt Cancer CenterTampaFlorida33612-
Sarah Cannon Cancer CenterNashvilleTennessee37203-
Baylor Charles A. Sammons Cancer Center at DallasDallasTexas75246-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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