Clinical Trial: Study for the Evaluation of Efficacy of Pembrolizumab (MK-3475) in Patients With Rare Tumors

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

Official Title: Phase II Study for the Evaluation of Efficacy of Pembrolizumab (MK-3475) in Patients With Rare Tumors

Brief Summary: The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475) can help control the disease in patients with advanced cancer.

Detailed Summary:

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on your disease type. There will be 10 groups enrolled on this study for the 10 different disease types being tested. Up to 25 participants will be enrolled in each of the 10 disease groups.

Study Drug Administration:

You will receive pembrolizumab by vein over 30 minutes on Day 1 of each 21-day study cycle. The time between doses may increase if you have side effects.

Study Visits:

On Day 1 of Cycle 1:

  • You will have a physical exam.
  • Blood (about 3 teaspoons) will be drawn for routine tests.
  • If you can become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

Every week until Week 9, every 2 weeks between Weeks 9 and 54, and then every 4 weeks after that until Week 81 or your treatment ends, whichever comes first, you will complete a questionnaire about your health and how you are feeling. This questionnaire will be either emailed to you or you will receive a phone call and an automated voice system will ask you these questions.

Between Days 15-21 of Cycle 1:

  • If the doctor thinks it is possible, you will have a tumor biopsy performed for PD testing.
  • Blood (about 2 teaspoons) will be drawn for PD testing.

On Day
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Non-Progression Rate (NPR) of Pembrolizumab in Participants with Rare Tumors [ Time Frame: 27 weeks ]

Clinical efficacy measured by non-progression rate (NPR) defined as the percentage of patients who are alive and progression-free at 27 weeks as assessed RECIST criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall Response Rate of Pembrolizumab in Participants with Rare Tumors [ Time Frame: 13 weeks ]

Overall response rate assessed using modified RECIST 1.1 criteria.


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: March 23, 2016
Date Started: August 2016
Date Completion: August 2019
Last Updated: May 11, 2017
Last Verified: May 2017