Microsatellite Stable Colorectal Cancer Clinical Trial
— CheckMate142Official title:
A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer
| Verified date | May 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.
| Status | Active, not recruiting |
| Enrollment | 385 |
| Est. completion date | June 28, 2024 |
| Est. primary completion date | June 28, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Histologically confirmed recurrent or metastatic colorectal cancer - Measurable disease per RECIST v1.1 - Microsatellite instability expression detected by an accredited laboratory - Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease Exclusion Criteria: - Active brain metastases or leptomeningeal metastases are not allowed - Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways - Prior malignancy active within the previous 3 years except for locally curable cancers - Participants with active, known or suspected autoimmune disease - Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0037 | Melbourne | Victoria |
| Australia | Local Institution - 0039 | Southport | Queensland |
| Australia | Local Institution - 0040 | Westmead | New South Wales |
| Belgium | Local Institution - 0018 | Brussels | |
| Belgium | Local Institution - 0019 | Brussels | |
| Belgium | Local Institution - 0020 | Leuven | |
| Canada | Local Institution - 0027 | Edmonton | Alberta |
| Canada | Local Institution - 0016 | Toronto | Ontario |
| France | Local Institution - 0025 | Paris | |
| Ireland | Local Institution - 0022 | Dublin 4 | |
| Ireland | Local Institution - 0023 | Dublin 9 | |
| Ireland | Local Institution - 0033 | Galway | |
| Italy | Local Institution - 0030 | Candiolo, Torino | |
| Italy | Local Institution - 0035 | Modena | |
| Italy | Local Institution - 0032 | Padova | |
| Spain | Local Institution - 0010 | Madrid | |
| Spain | Local Institution - 0012 | Madrid | |
| Spain | Local Institution - 0011 | Sevilla | |
| United States | Local Institution - 0041 | Allentown | Pennsylvania |
| United States | Local Institution - 0008 | Atlanta | Georgia |
| United States | Local Institution - 0002 | Boston | Massachusetts |
| United States | Local Institution - 0036 | Boston | Massachusetts |
| United States | Local Institution - 0024 | Durham | North Carolina |
| United States | Local Institution - 0028 | Gilbert | Arizona |
| United States | Local Institution - 0003 | Houston | Texas |
| United States | Local Institution - 0004 | Los Angeles | California |
| United States | Allina Health System dba Virginia PIper Cancer Institute | Minneapolis | Minnesota |
| United States | Local Institution - 0034 | Minneapolis | Minnesota |
| United States | Local Institution - 0006 | Nashville | Tennessee |
| United States | Local Institution - 0013 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0005 | Portland | Oregon |
| United States | Local Institution - 0001 | San Francisco | California |
| United States | Local Institution - 0029 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Belgium, Canada, France, Ireland, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator | The final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (Approximately up to 34 months) | ||
| Secondary | ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC) | The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months) |
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