UM1: Nivo and Anal Cancer - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn about any good and bad effects of nivolumab in combination with ipilimumab and to learn if biomarker tests are helpful to decide if people will benefit from these treatments. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drugs.
Advanced anal canal cancer
Who Can Participate in the Study?
-- Adult patients with confirmed previously treated metastatic squamous cell carcinoma of the anal canal
-- Willing to undergo testing for HIV testing if not tested within the past 6 months.
What is Involved?
If you join the study you will be enrolled in Part B
-- You will be put into a group by chance (like flipping a coin). Your doctor will not choose and you cannot choose which study group you are in. You will have an equal chance of being in either group.
-- You will receive either Nivolumab OR Nivolumab plus Ipilimumab.
-- Nivolumab will be given intravenously through your vein over 30 minutes once every 4 weeks.
--- If you are assigned to Ipilimumab group, it will be given intravenously through your vein over 30 minutes once every 8 weeks.
You will receive nivolumab alone or nivolumab with ipilimumab for as long as you receive clinical benefit.
After you finish treatment, the study team will continue to watch you for side effects for at least 100 days.