Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)

Part of paid clinical trials in Duarte, California.

Sponsor
Bayer
Study ID
NCT04126733
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Regorafenib (Stivarga, BAY73-4506) — DRUG
    Regorafenib administered as oral tablets given every day for 3 weeks of each 28 days treatment cycle (i.e., 3 weeks on, 1 week off)
  • Nivolumab (Opdivo) — BIOLOGICAL
    Administered on day 1 of every treatment cycle.

Study Details

The purpose of this study is to learn if combination of the two drugs regorafenib and nivolumab is an effective treatment for pMMR - MSS colorectal cancer, a special type of cancer of the colon or rectum (pMMR stands for proficient Mismatch Repair; MSS stands for Microsatellite Stable) and whether it is safe for patients. Regorafenib works by blocking several different proteins involved in tumor growth. Nivolumab is an immunotherapy drug encouraging the body's own immune system to attack cancer cells. Both drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.

Key Dates

Start date
Oct 14, 2019
Status verified
Jun 2023
Primary completion
Nov 11, 2020
Completion
Mar 28, 2022

Study Design

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

Arms

  • Experimental: Regorafenib + Nivolumab

Primary Outcome Measure

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 Assessed by Investigator [ Time Frame: Through database cut-off date of 11-NOV-2020 (Primary Completion Date) (up to 13 months) ]

Locations (15)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Rocky Mountain Cancer CentersDenverColorado80218-
Miami Cancer Institute at Baptist Health South FloridaMiamiFlorida33176-
Illinois Cancer SpecialistsArlington HeightsIllinois60005-
Minnesota Oncology Hematology, PAMinneapolisMinnesota55404-
Nebraska Cancer SpecialistsPapillionNebraska68046-
New York Oncology Hematology. P.C.AlbanyNew York12206-
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401-
Sarah Cannon Cancer CenterNashvilleTennessee37203-
Texas Oncology-Arlington NorthArlingtonTexas76012-
Baylor Charles A. Sammons Cancer Center at DallasDallasTexas75246-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology-ShermanShermanTexas75090-
Virginia Oncology AssociatesNewport NewsVirginia23606-
Northwest Cancer Specialists, PCVancouverWashington98684-

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope National Medical Center· Duarte, CARocky Mountain Cancer Centers· Denver, COMiami Cancer Institute at Baptist Health South Florida· Miami, FLIllinois Cancer Specialists· Arlington Heights, ILMinnesota Oncology Hematology, PA· Minneapolis, MNNebraska Cancer Specialists· Papillion, NE

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