Nivolumab plus ipilimumab may be an effective combination for patients with heavily pretreated metastatic sarcoma, according to research published in The Lancet Oncology.1

Patients with metastatic sarcoma, which carries an average overall survival of 16 months at diagnosis, have few treatment options. Previous research suggested that PD-1 and CTLA-4 checkpoint inhibition may be effective in this patient population regardless of PD-L1 status.

For this randomized phase 2 study ( Identifier: NCT02500797), researchers enrolled patients with metastatic sarcoma treated with at least 1 previous line of therapy to receive nivolumab monotherapy or nivolumab with ipilimumab. The primary endpoint was objective response.

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Of 96 enrolled patients, 42 patients were assigned to each group and were included in the safety analysis. In the nivolumab and combination groups, respectively, the median ages were 56 and 57 years, 60% and 62% of patients had received at least 3 prior therapies, and the most common sarcoma subtype was leiomyosarcoma (35% and 33% of patients).

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The median follow-up was 13.6 months in the nivolumab group and 14.2 months in the combination group. Two (5%) and 6 (16%) confirmed responses were noted in the monotherapy and combination groups, respectively. The 2 responses noted in the nivolumab monotherapy group had a duration of 3.2 months and 11.6 months; the median duration of response in the combination group was 6.2 months.

Responses were not noted in any particular disease subtype over others.

Median progression-free survival was 1.7 months in the monotherapy group; median overall survival was 10.7 months. In the combination group, median progression-free survival was 4.1 months and median overall survival was 14.3 months.

While no treatment-related deaths were noted, serious adverse events occurred in 8 (19%) patients in the monotherapy group and in 11 (26%) patients in the combination group.

The authors concluded that “those who received nivolumab plus ipilimumab met the predefined activity endpoint, thereby warranting further study.”


  1. D’Angelo SP, Mahoney MR, Van Tine BA, et al. Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials. Lancet Oncol. 2018 Jan 19. doi: 10.1016/S1470-2045(18)30006-8 [Epub ahead of print]