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

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

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.

It had 1 arm (groups): Goserelin Acetate + Pembrolizumab (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

This study will use a Simon 2-stage phase II trial design.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Measurable disease according to RECIST v1.1 for solid tumors within 28 days prior to registration.

The full record lists 20 inclusion and 19 exclusion criteria; among the exclusions: women of childbearing age with a positive serum pregnancy test within 72 hours prior to study registration; 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.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Goserelin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-05-30 with completion listed for 2026-07.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Objective Response Rate (time frame: 35 months).

It also tracked 4 secondary outcomes, for example Progression Free Survival, Disease Control Rate, Assess Adverse Events and Overall Survival.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.