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.
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
Interventions
Drug | Synonyms | Arms |
---|
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
Name | Type | Description | Interventions |
---|
Regorafenib + Nivolumab | Experimental | | - 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 Mismatch repair deficient (dMMR) / microsatellite instable-high
(MSI-H) colorectal cancer
- 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
- Arterial thrombotic or embolic events such as cerebrovascular accident (including
transient ischemi attacks) within 6 months before the start of study medication.
Active pulmonary emboli or deep vein thrombosis that are significant or not adequately
controlled on anticoagulation regimen
- 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: | Active, not recruiting |
Lead Sponsor: | Bayer |
Last Updated
August 2, 2021