Pembrolizumab in Refractory Metastatic Anal Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02919969|
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : November 25, 2016
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:
|Condition or disease||Intervention/treatment||Phase|
|Anal Cancer||Drug: Pembrolizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase 2 Clinical Trial of Pembrolizumab in Refractory Metastatic Anal Cancer|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2024|
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
- 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.
- PD-L1 Positive Response Rate [ Time Frame: 36 months ]Response rate in PD-L1 positive metastatic anal cancer patients will be evaluated by RECIST 1.1.
- Overall Survival [ Time Frame: 36 months ]Evaluate the durability of pembrolizumab responses in PD-L1 positive metastatic anal cancer patients by measuring median overall survival.
- Progression Free Survival [ Time Frame: 36 months ]Evaluate the durability of pembrolizumab responses in PD-L1 positive metastatic anal cancer patients by measuring median progression free survival.
- Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab [ Time Frame: Every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment ]Assess how well pembrolizumab is tolerated in patients with metastatic anal cancer by evaluating adverse events by CTCAE v4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919969
|Contact: James Cleary, MD, PhD||617-632-6073|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Eunice Kwak, MD, PhD 617-724-4000|
|Principal Investigator: Eunice Kwak, MD, PhD|
|Beth Israel Deaconess Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Benjamin Schlechter, MD PhD 617-667-3725|
|Principal Investigator: Benjamin Schlechter, MD PhD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: James Cleary, MD, PhD 617-632-6073|
|Principal Investigator: James Cleary, MD, PhD|
|Principal Investigator:||James Cleary, MD, PhD||Dana-Farber Cancer Institute|