KEY TAKEAWAYS
- The study aimed to evaluate if stopping ICIs early is safe for individuals with unresectable stage III or metastatic melanoma on combination therapy.
- The primary endpoint was the rate of ongoing response.
- The results concluded that shorter nivolumab treatment was preferred for patients with favorable tumor responses.
Patients with unresectable stage III or metastatic melanoma, often with poor prognostic factors, commonly receive a combination of immune checkpoint inhibitors (ICIs), specifically ipilimumab and nivolumab. This treatment approach is associated with severe immune-related adverse events (irAEs) in approximately 60% of individuals.
Typically, patients undergo ICI therapy for up to 2 years or until disease progression or unacceptable adverse events occur. The incidence of irAEs tends to rise with prolonged treatment duration. Despite observing enduring tumor responses following early treatment discontinuation, consensus on the optimal treatment duration remains elusive.
J C Janssen and the team aimed to assess the safety of early discontinuation of ICIs in individuals with unresectable stage III or metastatic melanoma receiving combination therapy.
The Safe Stop IPI-NIVO trial is a nationwide, multicenter, prospective, single-arm, interventional study conducted in the Netherlands. It aims to include 80 patients with unresectable stage III or metastatic melanoma who are undergoing combination therapy with ipilimumab-nivolumab and have achieved a complete or partial response (CR/PR) according to RECIST v1.1. These patients will be enrolled to undergo early discontinuation of maintenance therapy with anti-PD-1.
The primary endpoint was the rate of ongoing response at 12 months after the initiation of ICI treatment. Secondary endpoints were ongoing response at 24 months, disease control at various time points, melanoma-specific and overall survival, the incidence of immune-related adverse events (irAEs), and health-related quality of life.
From medical, healthcare, and economic viewpoints, avoiding overtreatment is paramount, favoring shorter ICI durations if safe, especially for individuals with favorable tumor responses.
The trial was sponsored by the Erasmus Medical Center.
Source: https://pubmed.ncbi.nlm.nih.gov/38783238/
Clinical Trial: https://clinicaltrials.gov/study/NCT05652673
Janssen JC, van Dijk B, de Joode K, et al. (2024). “Safe Stop IPI-NIVO trial: early discontinuation of nivolumab upon achieving a complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab – study protocol.” BMC Cancer. 2024 May 23;24(1):632. doi: 10.1186/s12885-024-12336-0. PMID: 38783238.
