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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)

NCT04126733

Description:

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.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 20975
  • NCT ID: NCT04126733

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
Regorafenib (BAY73-4506, Stivarga)Regorafenib + Nivolumab
Nivolumab (Opdivo)Regorafenib + Nivolumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Regorafenib + NivolumabExperimental
  • Regorafenib (BAY73-4506, Stivarga)
  • Nivolumab (Opdivo)

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR (Overall response rate) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Time Frame:Up to 1 year
Safety Issue:
Description:The proportion of patients with overall response of Complete Response (CR) or Partial Response (PR).

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:Approximately 2 years
Safety Issue:
Description: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).
Measure:Disease control rate (DCR)
Time Frame:Up to 1 year
Safety Issue:
Description:Disease control is defined as tumor response of stable disease or better.
Measure:Progression-free survival (PFS)
Time Frame:Approximately 2 years
Safety Issue:
Description:PFS is the time from first dose of study medication to disease progression or death, whichever is earlier.
Measure:Overall survival (OS)
Time Frame:Approximately 2 years
Safety Issue:
Description:OS is defined as time from first dose to death.
Measure:Incidence and severity of adverse events (AEs) per Common terminology criteria for adverse events (CTCAE) v5
Time Frame:Approximately 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bayer

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