Actively Recruiting
Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma
Led by Manish Patel · Updated on 2025-12-31
20
Participants Needed
7
Research Sites
374 weeks
Total Duration
On this page
Sponsors
M
Manish Patel
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- Locally advanced, recurrent, or metastatic androgen receptor-positive salivary gland carcinoma not suitable for surgery or radiation
- ECOG Performance Status of 0 or 1 within 28 days before registration
- Archival tumor tissue available confirming androgen receptor positivity with at least 20% of tumor cells staining positive
- Measurable disease by RECIST v1.1 within 28 days before registration
- For previously treated patients, documented disease progression on prior therapy
- Prior chemotherapy, radiation, or surgery allowed if not including anti-androgen or immune checkpoint therapy
- Recovery from toxic effects of prior cancer treatments to Grade 1 or less (except hair loss)
- Adequate organ function as defined by specific blood counts and liver/kidney function tests within 28 days before registration
- Male participants must agree to use contraception during treatment and for 8 months after last dose
- Females of childbearing potential must have a negative pregnancy test within 72 hours before registration
- Agreement to abstain or use effective contraception from consent until 8 months after treatment
- Ability to understand and comply with study procedures for entire study duration
You will not qualify if you...
- Women of childbearing age with a positive pregnancy test within 72 hours before registration
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other immunomodulatory T-cell receptor agents
- Prior androgen deprivation therapy including orchiectomy, GnRH agonists/antagonists, androgen receptor blockers, abiraterone, or enzalutamide
- Prior systemic anti-cancer therapy including investigational agents within 14 days before registration
- History of allogenic tissue or solid organ transplant
- Prior palliative radiotherapy within 7 days before study treatment start
- Live vaccine within 28 days before first study drug dose
- Immunodeficiency or use of systemic steroids over 10 mg prednisone equivalent within 7 days before first study drug dose
- Active malignancy requiring treatment within past 2 years except certain skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- Grade 3 or higher hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known active tuberculosis
- Conditions or therapies interfering with study participation or results
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnancy, breastfeeding, or planning conception during study and 120 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
2
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
Univeristy of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
University of Minnesota: Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
7
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
M
Manish Patel, MD
CONTACT
A
Amber Ryba
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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