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BTCRC HN17-111: A Phase 2 Trial of Androgen Deprivation Therapy (ADT) and Pembrolizumab for Treatment of Advanced-Stage Androgen Receptor (AR)-Positive Salivary Gland Carcinoma
Abstract   Peer reviewed

BTCRC HN17-111: A Phase 2 Trial of Androgen Deprivation Therapy (ADT) and Pembrolizumab for Treatment of Advanced-Stage Androgen Receptor (AR)-Positive Salivary Gland Carcinoma

J.Y. Bruce, N. Fujioka, F. Worden, R. Mehra, D. Laux, Y.K. Chae, A. Sulahadeen, D. Pease, Q. Cao, R. Kimple, …
International journal of radiation oncology, biology, physics, Vol.125(1), pp.e23-e23
05/01/2026
DOI: 10.1016/j.ijrobp.2026.02.046

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Abstract

Salivary gland cancers (SGC) are rare malignancies with no standard systemic therapy available for patients with recurrent or metastatic disease. Androgen receptors (AR) are expressed and functional on many SGCs. Preclinical data suggested possible synergy between androgen-deprivation therapy (ADT) and immune checkpoint blockade. The Big Ten Cancer Research Consortium conducted an open-label, multi-center, Simon's two-stage, phase II trial using goserelin with pembrolizumab for advanced SGC expressing AR. Here, we report the final results of the phase 2 trial Patients with recurrent or metastatic SGC (any histology) with at least 20% of tumor cells expressing AR by immunohistochemistry and treated with palliative intent were recruited. Patients were treated with subcutaneous injection of goserelin 3.6 mg every 4 weeks. Pembrolizumab 200mg was administered intravenously every 3 weeks starting 14 days after initiation of 1st dose of goserelin. Disease assessment was performed after completion of 4 cycles of therapy. The primary endpoint was objective response rate (ORR). Key secondary endpoints included PFS, OS, and safety of the combination. Stopping rules for excessive toxicity were employed. We planned enrollment of 9 patients in the initial stage and plan to complete enrollment of a total of 20 patients if ≥2 objective responses were observed. If we observed ≥4 responses, we would deem this regimen worthy of further study. We previously reported the results of the first stage of enrollment. Here we present the final results of the completed trial. Between June 2019 and May 2024, 19 patients were enrolled. Majority of patients were female (84%) with a median age of 71 (59-90). 89.5% of patients were white. Most patients (79%) had at least one prior line of systemic therapy while 21% had no prior systemic treatment. The vast majority of patients had salivary duct carcinoma (68%) and adenocarcinoma NOS (26%), while 1 patient had adenoid cystic carcinoma. The majority of patients (89%) had distant metastatic disease at time of enrollment. Objective response was seen in 7/19 patients (37%), but 2 of these were not confirmed on subsequent imaging for an ORR of 27.8% meeting the primary endpoint. Median PFS was 5.8m (95% CI 1.01-22.5) and median OS was 16.1m (95% CI 8.5-34.5). 6m and 12m OS was 89% and 73%, respectively. 6m and 12m PFS was 62% and 34%, respectively. Median duration of response was 12.1m (8.3-21.4). The regimen was safe with no treatment related deaths and there were no new safety concerns. The combination of goserelin with pembrolizumab is a safe and effective regimen for AR expressing salivary gland cancers and is worthy of future study. Confirmed objective responses were observed in 27.8% in a predominantly pre-treated patient population exceeding what might be expected with hormonal therapy or immune checkpoint blockade alone. Goserelin and pembrolizumab combination represents a promising therapeutic strategy for these patients.

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