Pembrolizumab in Metastatic Anal Cancer
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02919969 |
Recruitment Status :
Active, not recruiting
First Posted : September 30, 2016
Last Update Posted : May 3, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | September 2, 2016 | |||
First Posted Date ICMJE | September 30, 2016 | |||
Last Update Posted Date | May 3, 2022 | |||
Actual Study Start Date ICMJE | October 11, 2016 | |||
Actual Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Response Rate [ Time Frame: 36 months ] Overall response rate of pembrolizumab in metastatic anal cancer patients will be evaluated by RECIST 1.1.
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Original Primary Outcome Measures ICMJE |
Overall Response Rate [ Time Frame: 36 months ] Overall response rate of pembrolizumab in refractory, metastatic anal cancer patients will be evaluated by RECIST 1.1.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Pembrolizumab in Metastatic Anal Cancer | |||
Official Title ICMJE | A Multicenter Phase 2 Clinical Trial of Pembrolizumab in Metastatic Anal Cancer | |||
Brief Summary | This research study is studying a targeted therapy as a possible treatment for advanced anal cancer. The following intervention will be involved in this study: -Pembrolizumab |
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Detailed Description | This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for Advanced Anal Cancer, but it has been approved for other uses. Pembrolizumab, also known as KEYTRUDA or MK-3475, is approved in the USA and several other countries to treat a type of skin cancer called Malignant Melanoma. In this research study the investigators are studying an investigational drug called Pembrolizumab, which is a monoclonal antibody. Monoclonal antibodies are manmade and mimic proteins in the immune system by attaching to specific proteins in the body. T cells are cells in the immune system that are controlled by PD-1. PD-1 is a protein on the T cells that prevent the body from overproducing T cells. Pembrolizumab targets PD-1, attaches to it and blocks its action. By preventing PD-1 from working, T cell production rises and the body's immune system may increase its action against Cancer cells. Clinical and laboratory studies using pembrolizumab suggest that pembrolizumab may be useful in shrinking certain tumors. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Anal Cancer | |||
Intervention ICMJE | Drug: Pembrolizumab
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Other Names:
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Study Arms ICMJE | Experimental: Pembrolizumab
Intervention: Drug: Pembrolizumab
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
32 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | March 2023 | |||
Actual Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Adequate Organ Function Laboratory Values System Laboratory Value
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02919969 | |||
Other Study ID Numbers ICMJE | 16-301 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | James Cleary, MD, PhD, Dana-Farber Cancer Institute | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Merck Sharp & Dohme LLC | |||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | April 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |