Phase II Study of Nivolumab and Ipilimumab for Treatment of Metastatic/Recurrent Adenoid Cystic Carcinoma (ACC) of all Anatomic Sites of Origin and Other Malignant Salivary Gland Tumors.

OBJECTIVE

Dual checkpoint inhibitor therapy with nivolumab and ipilimumab has been FDA approved for a number of cancer sites. However, its role in the treatment of ACC and non-ACC salivary gland carcinomas (non-ACC SGC) is not well established.

METHODS AND ANALYSIS: We performed Simon's two-stage prospective single-institution Phase II clinical trial of nivolumab with ipilimumab. Two cohorts were analyzed: patients with metastatic/recurrent ACC and patients with non-ACC SGC. The primary endpoint was median progression-free survival (PFS); secondary endpoints were overall response rate (ORR), overall survival (OS), and toxicity.

RESULTS

Patient enrollment was prematurely terminated due to funding constraints. In total, 19 patients with ACC and 5 patients with non-ACC SGC were enrolled. The patients with ACC had a median OS of 30.0 months (95% CI 15.3-NR months), a median PFS of 8.3 months (95% CI 5.5-30.0 months), and a disease control rate (DCR) of 53% (10/19). The ORR in the ACC group was 5% (CR 0%, n = 0; confirmed PR 5%, n = 1), with one patient having continued stable disease at the time of trial conclusion. The patients with non-ACC SGC had a median OS of 10.4 months (95% CI 6.21-NR months), a median PFS of 6.21 months (95% CI 2.83-NR months), and a DCR of 40% (2/5). The ORR in this cohort was 0%.

CONCLUSION

In patients with recurrent or metastatic ACC and non-ACC SGC, the combination of nivolumab with ipilimumab resulted in moderate disease control. Further studies are warranted to validate our findings.

TRIAL NUMBER: NCT03146650.