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ETCTN 9673: Nivo and Ipi in 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.

What is the Condition Being Studied?

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.

Age Group
Adults

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.

Study Details

Full Title
A Multi-Institutional Phase 2 Study of Nivolumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00064189
NCT:NCT02314169
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698