Findings from a Phase 2 clinical trial for angiosarcoma have just been announced. These findings have demonstrated that the combination of nivolumab and ipilimumab may improve outcomes for patients.
This trial was called DART.
The DART Trial
The DART trial included 16 patients who were diagnosed with angiosarcoma. All patients were at least 18 years old and had adequate end-organ function. The study’s primary endpoint was overall response rate. Secondary endpoints included progression-free survival, toxicity, and overall survival.
This trial was part of a larger investigation. Angiosarcoma was just one of 53 cohorts of patients.
All patients received 240mg of nivolumab via IV once every 2 weeks, as well as 1mg/kg of IV ipilimumab once every 6 weeks. The patients were assessed first at baseline and then at week 8, week 16, week 24, and every 12 weeks until progression was experienced.
Some of the most notable findings were-
- Overall response rate of 25%
- 4 confirmed responses
- Duration of response ranged from 5 to 13 months
- 2 patients were documented as having ongoing responses
- 1 patient had a reduction in tumor size but faced disease progression during follow up
- 2 patients reached stable disease and achieved such for over 6 months
- The treatment showed benefits for all tumor types including those who had cutaneous tumors in the scalp or face
- These individuals had an overall response rate of 60%
- 1 patient who had breast angiosarcoma experienced an objective response
- Overall progression-free survival for 6 months was 38%
75% of all participants in this trial did experience an adverse event, however, only 25% of participants experienced an AE that was grade 3 or grade 4. Two patients did stop the trial due to toxicity.
Researchers explain that these findings were notable because this study was the first to include all angiosarcomas in an immunotherapy investigation. They also discuss that additional, collective investigations are needed to improve our understanding of the different molecular properties of these conditions, and how they may best be treated.
You can read more about this study and its findings here.
Wagner M, Othus M, Patel SP, et al. Multicenter phase II trial (SWOG S1609, cohort 51) of ipilimumab and nivolumab in metastatic or unresectable angiosarcoma: a substudy of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART). 2021;9:e002990. doi:10.1136/jitc-2021-002990