Clinical Trial: Pembrolizumab in Refractory Metastatic Anal Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter Phase 2 Clinical Trial of Pembrolizumab in Refractory 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


Detailed Summary:

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.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: September 2, 2016
Date Started: September 2016
Date Completion: March 2024
Last Updated: November 23, 2016
Last Verified: November 2016