NCT05491616

Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In an effort to prevent surgery in selected patients with esophageal cancer, the SANO-2 study offers active surveillance to patients with clinically complete response (cCR) after neoadjuvant chemoradiation (nCRT). Some of these patients will never develop locoregional and/or distant recurrence of disease (persistent cCR). However, two-thirds of the patients that undergo active surveillance still get disease recurrence. This can be locoregional regrowth or distant metastases. To increase the efficacy of active surveillance (reduce the proportion of patients that need surgery) and improve survival, effective systemic maintenance therapy is needed. The CheckMate 577 randomized, placebo controlled, clinical trial showed that Nivolumab increases disease free survival in patients after nCRT and esophagectomy. Objective: To assess the efficacy of nivolumab during active surveillance in patients with cCR after neoadjuvant chemoradiation for esophageal cancer

Detailed description

The rationale of maintenance nivolumab in patients with cCR undergoing active surveillance is to decrease the risk for disease recurrence and improve survival as well as to optimize the chance for having an organ sparing treatment. In this non-randomized phase II study we will assess the efficacy of maintenance nivolumab in patients who are undergoing active surveillance after nCRT in the context of the SANO-2 trial: the SANO-3 study. The SANO-3 study aims to identify a new indication for immunotherapy in primary esophageal cancer: patients who have been identified as a clinical complete responders 10-14 weeks after nCRT can be included. This subgroup of patients will not undergo standard surgery but instead continue with active surveillance after nCRT when they opt for participation in the SANO-2 trial.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	In this SANO-3 study, patients will receive Nivolumab at 480mg Q4W starting 10-14 weeks after nCRT (i.e., when cCR has been established) until disease progression or unacceptable toxicity, for a maximum duration of 1 year.

Timeline

• Start date: 2022-09-29
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-08-08
• Last updated: 2025-02-13

Locations

1 site across 1 country: Netherlands