DREAMseq
Trial question
What is the role of a combination of nivolumab and ipilimumab in patients with BRAFV600-mutant metastatic melanoma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 265
265 patients (98 female, 167 male).
Inclusion criteria: patients with treatment-naïve BRAFV600-mutant metastatic melanoma.
Key exclusion criteria: major surgery or radiation therapy within 14 days of starting study treatment; autoimmune disease that might recur and affect vital organ function or require immunosuppressive treatment; CVD; history of retinal vein occlusion.
Interventions
N=133 nivolumab and ipilimumab (nivolumab 1 mg/kg and ipilimumab 3 mg/kg once every 3 weeks for 4 doses, followed by nivolumab 240 mg IV once every 2 weeks for up to 72 weeks).
N=132 dabrafenib and trametinib (dabrafenib 150 mg BID and trametinib 2 mg once daily until progressive disease).
Primary outcome
Overall survival rate at 2 years
71.8%
51.5%
71.8 %
53.8 %
35.9 %
17.9 %
0.0 %
Nivolumab and
ipilimumab
Dabrafenib and
trametinib
Significant
increase ▲
NNT = 4
Significant increase in overall survival rate at 2 years (71.8% vs. 51.5%; AD 20.3%, 95% CI 2.6 to 37.9).
Secondary outcomes
No significant difference in median progression-free survival at 2 years (11.8 months vs. 8.5 months; AD 3.3 months, 95% CI -0.06 to 6.66).
No significant difference in objective response rate (46% vs. 43%; AD 3%, 95% CI -11.11 to 17.11).
Safety outcomes
No significant difference in grade ≥ 3 treatment-related adverse events.
Conclusion
In patients with treatment-naïve BRAFV600-mutant metastatic melanoma, nivolumab and ipilimumab were superior to dabrafenib and trametinib with respect to overall survival rate at 2 years.
Reference
Michael B Atkins, Sandra J Lee, Bartosz Chmielowski et al. Combination Dabrafenib and Trametinib Versus Combination Nivolumab and Ipilimumab for Patients With Advanced BRAF-Mutant Melanoma: The DREAMseq Trial-ECOG-ACRIN EA6134. J Clin Oncol. 2023 Jan 10;41(2):186-197.
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