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Report for Clinical Trial NCT04126733

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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)

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.

NCT04126733 Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

2 Interventions

Name: Regorafenib (BAY73-4506, Stivarga)

Description: 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)
Type: Drug
Group Labels: 1

Regorafenib + Nivolumab

Name: Nivolumab (Opdivo)

Description: Administered on day 1 of every treatment cycle.
Type: Biological
Group Labels: 1

Regorafenib + Nivolumab


Primary Outcomes

Description: The proportion of patients with overall response of Complete Response (CR) or Partial Response (PR).

Measure: ORR (Overall response rate) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

Time: Up to 1 year

Secondary Outcomes

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: Duration of Response (DOR)

Time: Approximately 2 years

Description: Disease control is defined as tumor response of stable disease or better.

Measure: Disease control rate (DCR)

Time: Up to 1 year

Description: PFS is the time from first dose of study medication to disease progression or death, whichever is earlier.

Measure: Progression-free survival (PFS)

Time: Approximately 2 years

Description: OS is defined as time from first dose to death.

Measure: Overall survival (OS)

Time: Approximately 2 years

Measure: Incidence and severity of adverse events (AEs) per Common terminology criteria for adverse events (CTCAE) v5

Time: Approximately 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

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 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. --- V600E ---

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 Colorectal Cancer Colorectal Neoplasms null --- V600E ---



HPO Nodes


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