Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors — iPRIME  

Thyroid Cancer Clinical Trial

Official title: Synergy of Pembrolizumab Anti-PD-1 Immunotherapy With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors. The iPRIME Study.

Status Recruiting

Clinical Trial 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

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Salivary Gland Cancer
• Salivary Gland Neoplasms
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

• NCT number: NCT03360890
• Study type: Interventional
• Source: University of Chicago
• Contact: Cancer Clinical Trials Office
• Phone: 1-855-702-8222
• Email: cancerclinicaltrials@bsd.uchicago.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 26, 2018
• Completion date: September 2032