SWOG S1609

Official Title

Treatment with Ipilimumab and Nivolumab for Rare Cancers (DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors)

Study Purpose

To evaluate the effectiveness of treating rare cancers with two immunotherapy drugs: nivolumab and ipilimumab

Diagnosis

The following rare cancers: Undifferentiated carcinoma of the GI tract Rare pancreatic tumors Sarcomatoid carcinoma of the lung Bronchoalveolar carcinoma of the lung Epithelial tumors of the Penis Squamous cell carcinoma variants of the genitourinary sys

Eligibility

Must have cancer that has gotten worse on previous therapy and there are no other approved or standard therapy options available that have been shown to improve the chances of survival, or have cancer for which there is no standard treatment that exists.

May have had any number of treatments for disease including one of the drugs used in this trial but cannot have had both.

Must not have an autoimmune disease that has required treatment during the past 2 years.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

• Study agents: nivolumab, ipilimumab
• All patients will be treated with ipilumumab every six weeks and nivolumab every two weeks.
• Patients will stay on study therapy until their cancer gets worse or decide to stop therapy. 

After completion of study therapy, patients are followed for up to 10 years after study enrollment.