Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer (NCT03172624) | Clinical Trial Compass
CompletedPhase 2
Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer
United States64 participantsStarted 2017-05-26
Plain-language summary
The purpose of this study is to find out what effects, good and/or bad, treatment with two drugs called nivolumab and ipilimumab have on the participant and salivary cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Cohort 1 only: Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.
* Patients must have pathologically or cytologically confirmed salivary gland cancer of any histology except for adenoid cystic carcinoma.
* Patients must have recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
* At least 2 weeks must have elapsed since the end of prior systemic treatment and/or 4 weeks since completion of radiotherapy with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug treatment. Any number of prior therapies for recurrent/metastatic salivary gland cancer are allowed.
NOTE: Patients previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs prior to trials enrollment and concomitantly with study therapy.
* Patients must have RECIST v1.1 measurable disease.
* Cohort 1 and acinic cell carcinoma patients in Cohort 2 only: Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within 6 months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within 6 months prior to study enrollment. Note: This…