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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Manish Patel
Study ID
NCT03942653
Phase
PHASE2
Status
Recruiting

Conditions

  • Salivary Gland Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Goserelin Acetate — DRUG
    Goserelin Acetate, SQ, Q4W
  • Pembrolizumab — DRUG
    Pembrolizumab, IV, Q3W

Study Details

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.

Key Dates

Start date
May 30, 2019
Status verified
Dec 2025
Primary completion
Apr 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Goserelin Acetate + Pembrolizumab
    Goserelin Acetate, 3.6 mg, every four weeks, SQ Pembrolizumab, 200mg, every three weeks, IV

Primary Outcome Measure

Objective Response Rate [ Time Frame: 35 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Catie Humphreys
+1 312-695-1355
Victoria Villaflor, MD (PRINCIPAL_INVESTIGATOR)
University of Illinois Cancer CenterChicagoIllinois60612
Lauren Talasnik
3129966275
Lawrence Feldman, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Marian Anderson
3193534578
Douglas Laux, MD (PRINCIPAL_INVESTIGATOR)
Univeristy of MarylandBaltimoreMaryland21201
Amelia Barkman
4107063761
Ranee Mehra, MD (SUB_INVESTIGATOR)
University of Michigan Health SystemAnn ArborMichigan48109
Dawud Ellayan
+1 734-615-1749
Francis Worden, MD (PRINCIPAL_INVESTIGATOR)
University of Minnesota: Masonic Cancer CenterMinneapolisMinnesota55455
Manish Patel, M.D.
1 612-624-6940
University of WisconsinMadisonWisconsin53705
Sarah Stewart
+1 608-263-7898
Justin Bruce, MD (PRINCIPAL_INVESTIGATOR)

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