This study is NOT currently recruiting participants.
Number
17-C-0090
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: 110
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Fetuses;Children
Keywords
Immunotherapy; Immune Checkpoint Inhibition; Targeted Therapy; NCI MATCH
Recruitment Keyword(s)
None
Condition(s)
Rare Cancers
Investigational Drug(s)
Ipilimumab Nivolumab
Investigational Device(s)
Intervention(s)
Drug: Ipilimumab Drug: Nivolumab
Supporting Site
National Cancer Institute/SWOGNational Cancer Institute
For people with rare cancers, usual treatment is either surgery, radiation, drugs, or a combination of these, but there may be no standard of care treatment. Their cancer also may get worse with treatment. Researchers are testing the study drugs ipilimumab and nivolumab. They think these drugs combined may reduce symptoms or stop tumors from growing for several months or more in people with rare cancers.
Objective:
To test the effects of ipilimumab and nivolumab combined in treating rare cancers and cancers of unknown primary origin.
Eligibility:
People ages 18 and older who have been identified to have rare cancers
Design:
Participants will be screened with blood and urine tests.
Before starting treatment, participants will have:
Medical history
Physical exam
Computed tomography (CT) or magnetic resonance imaging (MRI) scan to measure their tumor: For the scans, they lie in a machine that takes pictures of the body.
Blood and urine tests
Optional tumor biopsy
Participants will get the study drugs over 6-week cycles. On day 1, they will get both drugs by vein and have blood tests. They will also give their medical history and have a physical exam. On days 15 and 29, they will get nivolumab only.
Participants will have CT or MRI every 8 12 weeks.
Participants will have treatment for as long as their cancer does not get worse and they can tolerate the side effects.
After they stop treatment, participants will have visits at least every 3 months for 3 years.
Participants may be asked to allow their blood and tissue samples and health records to be stored for future research.
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ELIGIBILITY CRITERIA: Adults with histologically confirmed rare cancer and/or cancer of unknown primary that did not have a match to a molecularly guided therapy on EAY131 "NCIMATCH" protocol or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations per EAY131, "NCIMATCH". Rare cancers eligible for this study were derived from the RareCare initiative and have an incidence of < 6/100,000/year; the study defines 30 individual histological strata as well as a stratum for cancers of unknown primary and a stratum for other rare tumors not specified in the prior strata.
Adults with histologically confirmed rare cancer and/or cancer of unknown primary that did not have a match to a molecularly guided therapy on EAY131 "NCIMATCH" protocol or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations per EAY131, "NCIMATCH".
Rare cancers eligible for this study were derived from the RareCare initiative and have an incidence of < 6/100,000/year; the study defines 30 individual histological strata as well as a stratum for cancers of unknown primary and a stratum for other rare tumors not specified in the prior strata.
Principal Investigator
Referral Contact
For more information: