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Trial record 64 of 196 for:    colon cancer | ( Map: Colorado, United States )

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04126733
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : November 15, 2019
Bristol-Myers Squibb
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Regorafenib (BAY73-4506, Stivarga) Biological: Nivolumab (Opdivo) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm, Phase II Study of Regorafenib and Nivolumab in Patients With Mismatch Repair-Proficient (pMMR)/Microsatellite Stable (MSS) Colorectal Cancer (CRC)
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : September 18, 2020
Estimated Study Completion Date : April 18, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Regorafenib + Nivolumab Drug: Regorafenib (BAY73-4506, Stivarga)
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)

Biological: Nivolumab (Opdivo)
Administered on day 1 of every treatment cycle.

Primary Outcome Measures :
  1. ORR (Overall response rate) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 [ Time Frame: Up to 1 year ]
    The proportion of patients with overall response of Complete Response (CR) or Partial Response (PR).

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Approximately 2 years ]
    DOR is defined for responders only as the time from first documentation of response (i.e. CR or PR) until disease progression or death (if death without documented disease progression).

  2. Disease control rate (DCR) [ Time Frame: Up to 1 year ]
    Disease control is defined as tumor response of stable disease or better.

  3. Progression-free survival (PFS) [ Time Frame: Approximately 2 years ]
    PFS is the time from first dose of study medication to disease progression or death, whichever is earlier.

  4. Overall survival (OS) [ Time Frame: Approximately 2 years ]
    OS is defined as time from first dose to death.

  5. Incidence and severity of adverse events (AEs) per Common terminology criteria for adverse events (CTCAE) v5 [ Time Frame: Approximately 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological confirmed advanced, metastatic, or progressive pMMR/MSS adenocarcinoma of colon or rectum
  • Participant must have progressed or be intolerant to prior systemic chemotherapy including fluoropyrimidines, irinotecan, oxaliplatin, anti-vascular endothelial growth factor (VEGF) therapy, and, if extended rat sarcoma viral oncogene homolog (RAS) wild type, an anti-epidermal growth factor receptor (EGFR) therapy. Exceptions may apply
  • Participants must have adequate organ and marrow function defined by protocol-specified laboratory tests
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Measurable disease as determined by response evaluation criteria in solid tumors (RECIST) v1.1
  • Provision of recently obtained tumor tissue as per protocol specified requirement
  • Anticipated life expectancy greater than 3 months
  • Be able to swallow and absorb oral tablets

Exclusion Criteria:

  • Participants with microsatellite instable-high (MSI-H) colorectal cancer or proto-oncogene BRAF (BRAF) V600E mutation
  • Prior therapy with regorafenib, anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of immunotherapy to treat cancer
  • Presence of active central nervous system (CNS) metastases; participants with stable CNS disease or previously treated lesions are eligible for study entry
  • Poorly controlled hypertension, defined as a blood pressure consistently above 150/90 mmHg despite optimal medical management
  • Participants with an arterial thrombotic or thromboembolic event within 6 months before the start of study medication
  • Any hemorrhage or bleeding event ≥ National Cancer Institute - Common terminology criteria for adverse events (NCI-CTCAE) Grade 3 within 28 days prior to the start of study medication
  • Participants with an active, known or suspected autoimmune disease
  • History of interstitial lung disease or pneumonitis
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection
  • Other protocol defined inclusion/exclusion criteria could apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04126733

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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937

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United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
United States, Colorado
Rocky Mountain Cancer Centers Not yet recruiting
Denver, Colorado, United States, 80218
United States, Florida
Miami Cancer Institute at Baptist Health South Florida Not yet recruiting
Miami, Florida, United States, 33176
United States, Illinois
Illinois Cancer Specialists Recruiting
Arlington Heights, Illinois, United States, 60005
United States, Minnesota
Minnesota Oncology Hematology, PA Recruiting
Minneapolis, Minnesota, United States, 55404
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Papillion, Nebraska, United States, 68046
United States, New York
New York Oncology Hematology. P.C. Recruiting
Albany, New York, United States, 12206
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Eugene, Oregon, United States, 97401
United States, Tennessee
Sarah Cannon Cancer Center Not yet recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical School Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology-Arlington North Not yet recruiting
Arlington, Texas, United States, 76012
Baylor Charles A. Sammons Cancer Center at Dallas Recruiting
Dallas, Texas, United States, 75246
University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Texas Oncology-Sherman Not yet recruiting
Sherman, Texas, United States, 75090
United States, Virginia
Virginia Oncology Associates Recruiting
Newport News, Virginia, United States, 23606
United States, Washington
Northwest Cancer Specialists, PC Recruiting
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Bristol-Myers Squibb

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Responsible Party: Bayer Identifier: NCT04126733     History of Changes
Other Study ID Numbers: 20975
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents