OncoMatch/Clinical Trials/NCT03942653
Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma
Is NCT03942653 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Goserelin Acetate and Pembrolizumab for salivary gland carcinoma.
Treatment: Goserelin Acetate · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: AR overexpression (IHC ≥ 20% tumor cells positive with moderate intensity (1+ or greater))
androgen receptor-positive salivary gland carcinoma...AR positivity will be defined according to IHC staining of tumor tissue with at least 20% of tumor staining positive with moderate intensity (1+ or greater)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
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)
Cannot have received: androgen deprivation therapy (orchiectomy, gonadotropin-releasing hormone (GnRH) agonists/antagonists, androgen receptor blocker, abiraterone, enzalutamide)
Has received prior androgen deprivation therapy including orchiectomy, gonadotropin-releasing hormone (GnRH) agonists/antagonists, androgen receptor blocker, abiraterone, or enzalutamide
Cannot have received: systemic anti-cancer therapy
Exception: within 14 days prior to registration
Has received prior systemic anti-cancer therapy including investigational agents within 14 days prior to registration
Cannot have received: palliative radiotherapy
Exception: within 7 days of start of study treatment
Has received prior palliative radiotherapy within 7 days of start of study treatment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Kidney function
Creatinine ≤1.5 × ULN OR measured/calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University Feinberg School of Medicine · Chicago, Illinois
- University of Illinois Cancer Center · Chicago, Illinois
- University of Iowa Hospitals and Clinics · Iowa City, Iowa
- Univeristy of Maryland · Baltimore, Maryland
- University of Michigan Health System · Ann Arbor, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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