RecruitingPhase 2NCT03942653

Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma

Phase II Trial of Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma: Big Ten Cancer Research Consortium BTCRC-HN17-111


Sponsor

Manish Patel

Enrollment

20 participants

Start Date

May 30, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase II, multi-center, single-arm, non-blinded study combining androgen deprivation therapy (ADT) and pembrolizumab for patients with metastatic or locally recurrent androgen receptor-positive salivary gland carcinoma, not amenable to surgery or radiation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of hormone-blocking therapy (androgen deprivation) and an immunotherapy drug called pembrolizumab for people with advanced salivary gland cancer that has a specific protein called the androgen receptor. These tumors can be hormone-sensitive, and combining hormone suppression with immunotherapy may improve outcomes. **You may be eligible if...** - You are at least 18 years old - You have locally advanced, recurrent, or metastatic salivary gland cancer - Your tumor tests positive for the androgen receptor - You are in adequate health (good physical functioning) - Prior chemotherapy is allowed but not required **You may NOT be eligible if...** - Your tumor does not have the androgen receptor - You have had prior immunotherapy with checkpoint inhibitors - You have active autoimmune disease - You are pregnant or breastfeeding - You have serious heart, lung, or other organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGoserelin Acetate

Goserelin Acetate, SQ, Q4W

DRUGPembrolizumab

Pembrolizumab, IV, Q3W


Locations(7)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Univeristy of Maryland

Baltimore, Maryland, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

University of Minnesota: Masonic Cancer Center

Minneapolis, Minnesota, United States

University of Wisconsin

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT03942653


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