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
Manish Patel
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.
Description
This is 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. Eligible patients will include both those with no prior systemic therapy and those who have failed prior systemic therapy. Patients who have received previous ADT or immunotherapy will be excluded. ADT will consist of goserelin acetate every 4 weeks with the first injection given approximately 2 weeks prior to the first dose of pe…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Local, pathologic testing of androgen receptor-positive salivary gland carcinoma will be performed as standard of care. Archival tissue must be available…
Interventions
- DrugGoserelin Acetate
Goserelin Acetate, SQ, Q4W
- DrugPembrolizumab
Pembrolizumab, IV, Q3W
Locations (7)
- Northwestern University Feinberg School of MedicineChicago, Illinois
- University of Illinois Cancer CenterChicago, Illinois
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Univeristy of MarylandBaltimore, Maryland
- University of Michigan Health SystemAnn Arbor, Michigan
- University of Minnesota: Masonic Cancer CenterMinneapolis, Minnesota