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.
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
Locally advanced, recurrent, or metastatic salivary gland carcinoma that is not amenable to curative surgery or radiation
ECOG Performance Status of 0 or 1 within 28 days prior to registration.
Women of childbearing age with a positive serum pregnancy test within 72 hours prior to study registration.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
Has received prior androgen deprivation therapy including orchiectomy, gonadotropin-releasing hormone (GnRH) agonists/antagonists, androgen receptor blocker, abiraterone, or enzalutamide.
Has received prior systemic anti-cancer therapy including investigational agents within 14 days prior to registration.
Single group
Goserelin Acetate
DrugGoserelin Acetate, SQ, Q4W
Pembrolizumab
DrugPembrolizumab, IV, Q3W
Objective Response Rate
Objective response rate to therapy (complete and partial responses) at 3 month intervals after beginning goserelin and pembrolizumab based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Progression Free Survival
Determine progression free survival (PFS) at 12 months, according to RECIST 1.1 criteria
Disease Control Rate
Disease control rate as defined by stable disease plus objective response (SD+PR+CR), according to RECIST 1.1 criteria
Assess Adverse Events
To evaluate the safety and tolerability of pembrolizumab when given with goserelin, grade 3,4,5 adverse events will be summarized according to CTCAE v5 criteria.
Overall Survival
Determine overall survival (OS) at 12 months, according to RECIST 1.1 criteria
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Manish Patel
Lead sponsor
Big Ten Cancer Research Consortium
Sponsor institution
Merck Sharp & Dohme LLC
Collaborator
