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ACTIVE NOT RECRUITING
NCT05491616
PHASE2

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

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

77

Start Date

2022-09-29

Completion Date

2026-10

Last Updated

2025-02-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

Erasmus MC

Rotterdam, Netherlands