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S1609 DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors
Protocol Number:
Phase II
Julie Brahmer
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin.
Generally health adults with rare cancer for which there is no standard of care treatment, or for which you have already received standard of care therapy options and your cancer has become worse may be eligible.
All study participants will get the same study drugs: ipilimumab and nivolumab. You will receive both study drugs through a vein on the first day of each cycle (or every 6 weeks), and you will receive nivolumab through a vein every 2 weeks. You will continue to receive study drugs until your disease gets worse or you experience bad side effects from the study drugs or your study doctor decides that you are not benefiting from the study drugs.You will receive the study drugs as long as your cancer does not get worse, the side effects are not too great, you agree to stay on study, your study doctor believes you are benefitting from the study drugs, and you do not have a treatment delay of more than 56 days. When you finish taking ipilimumab and nivolumab, your doctor will watch you for side effects and follow your condition with visits to the office at least every 3 months for 3 years, from your enrollment in the study. Your treating physician (or someone from your physician’s office) may also continue to contact you via phone or mail to follow-up on your status until 10 years after the time of your enrollment to the study.If your disease gets worse, and your study doctor believes that you are still benefiting from the study drugs (including review of laboratory test results), your study doctor may discuss whether you would like to continue receive study treatment. Since some patients have delayed responses to immunotherapy (the study drugs), you can continue to receive the study drugs for as long as you do not have any additional or new symptoms of your disease getting worse and your study doctor continues to believe that you are still benefiting from the study drugs. You may also decide not to continue treatment after your disease gets worse and your study doctor will discuss other options (such as other clinical trials, palliative care, or hospice care) with you.
Last Update
08/08/2020 05:02 AM