Spots Global Cancer Trial Database for Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors
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Trial Identification
Brief Title: Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors
Official Title: Synergy of Pembrolizumab Anti-PD-1 Immunotherapy With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors. The iPRIME Study.
Study ID: NCT03360890
Study Description
Brief Summary: Phase II, 2-cohort, single arm trial treated with the combination of the following two agents: 1. Pembrolizumab (MK3475) 200mg, every three weeks, iv 2. Docetaxel 75mg/m2, every three weeks, iv
Detailed Description: Eligible patients will be divided into two cohorts. Cohort 1: salivary gland tumors without SOC treatment option Cohort 2: 'aggressive' thyroid cancer without SOC treatment option Both cohorts will undergo a biopsy and will begin immunotherapy plus chemotherapy. Pembrolizumab and steroid sparing taxane: docetaxel will be given every three weeks for 3 to 6 cycles. For accessible tumors only, at week three patients will receive an on-treatment biopsy. Patients will move on to immunotherapy maintenance after completing their cycles. Pembrolizumab will be given every three weeks until disease progression or up to 35 cycles (about 2 years).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Contact Details
Name: Alexander Pearson
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
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