Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study (SANO-3)
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ClinicalTrials.gov Identifier: NCT05491616 |
Recruitment Status :
Recruiting
First Posted : August 8, 2022
Last Update Posted : March 12, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | August 2, 2022 | ||||
First Posted Date ICMJE | August 8, 2022 | ||||
Last Update Posted Date | March 12, 2024 | ||||
Actual Study Start Date ICMJE | September 29, 2022 | ||||
Estimated Primary Completion Date | April 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Disease Free survival 18 months [ Time Frame: 18 months ] No locoregional or distant recurrence of disease, evaluated by PETCT, EUS (Endoscopic Ultrasound), endoscopy + bite-on-bite biopsy
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study | ||||
Official Title ICMJE | Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study | ||||
Brief 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 |
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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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Esophageal Cancer | ||||
Intervention ICMJE | 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.
Other Name: Immune Checkpoint Inhibitor
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Study Arms ICMJE | Experimental: Nivolumab q4w
patients will receive Nivolumab at 480mg Q4W starting 10-14 weeks
Intervention: Drug: Nivolumab
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
74 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 2026 | ||||
Estimated Primary Completion Date | April 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05491616 | ||||
Other Study ID Numbers ICMJE | CA209-6KC | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Dr. B. (Bianca) Mostert, Erasmus Medical Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Erasmus Medical Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Erasmus Medical Center | ||||
Verification Date | March 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |