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Alliance A091605 (Merkel Cell Carcinoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug MK-3475 (pembrolizumab) and radiation is better, the same, or worse than MK-3475 (pembrolizumab) without radiation.

What is the Condition Being Studied?

Merkel Cell Carcinoma

Who Can Participate in the Study?

Adults who:
- Have Merkel Cell Carcinoma that is advanced or metastatic
- Have no prior immunotherapy for advanced or metastatic disease
- Have no other active cancer
- Are not pregnant or nursing

What is Involved?

If you choose to join this study, you will:

Be assigned to a study group (like a flip of a coin) to either:

- Get the study drug plus radiation
-- Get the radiation during the first 21 days of MK-3475 (pembrolizumab) only
-- Get radiation treatment that will include a planning session and 3 treatments
-- Be followed closely by your study doctor for side effects and your condition every 3 months for five years after you have finished the MK-3475 (pembrolizumab)

OR

- Get the study drug alone

The study drug MK-3475 (pembrolizumab) will be given through a vein in your arm for up to two years as long as it is helping treat your cancer.

Study Details

Full Title
Alliance A091605: A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00093117
NCT:NCT03304639
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698