Pembrolizumab + Chemotherapy for Thyroid and Salivary Gland Cancer
(iPRIME Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAlexander Pearson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Alexander Pearson

Principal Investigator

University of Chicago

Eligibility Criteria

Adults with certain types of thyroid or salivary gland tumors that can't be removed by surgery or treated with curative intent. Participants must have a life expectancy over 12 weeks, good performance status, and acceptable organ function. Women of childbearing potential and men must agree to use contraception. Exclusions include recent participation in other trials, known allergies to trial drugs, active infections like TB or hepatitis, significant heart disease, autoimmune diseases requiring treatment within the past 2 years, untreated brain metastases, pregnancy/breastfeeding.

Inclusion Criteria

You are expected to live for more than 12 weeks.

I have a type of salivary gland cancer.

My thyroid cancer is resistant to radioiodine and hasn't responded well to certain therapies, or it's aggressive.

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Exclusion Criteria

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

I have a history of lung inflammation not caused by infection.

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment

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Treatment Details

Interventions

Docetaxel (Anti-tumor antibiotic)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThis Phase II trial tests Pembrolizumab (200mg IV every three weeks) combined with Docetaxel (75mg/m2 IV every three weeks) on patients with specific thyroid and salivary gland cancers. It's a single-arm study where all participants receive the same treatment regimen.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort 2: 'aggressive' thyroid cancer without SOC treatment opExperimental Treatment2 Interventions

All patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).

Group II: Cohort 1: salivary gland tumors without SOC treatment optionExperimental Treatment2 Interventions

Docetaxel is already approved in Canada, Japan for the following indications: