Overview
Sponsor-declared trial summary
oesophageal cancer
To assess the efficacy of nivolumab during active surveillance in patients with cCR after neoadjuvant chemoradiation for esophageal cancer
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Sep 2022 → 11 Feb 2026
- Decision date (initial)
- 2024-09-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513635-24-00
- EudraCT number
- 2022-000355-37
- ClinicalTrials.gov
- NCT05491616
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the efficacy of nivolumab during active surveillance in patients with cCR after neoadjuvant chemoradiation for esophageal cancer
Secondary objectives 2
- Assess toxicity during and after this treatment
- Assess 2-year overall and distant metastases-free survival
Conditions and MedDRA coding
oesophageal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10030151 | Oesophageal cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Operable patients with locoregionally advanced squamous cell- or adenocarcinoma of the esophagus or esophagogastric junction who have completed neoadjuvant chemoradiotherapy (nCRT) and have clinically complete reponse at 10-14 weeks after nCRT and are in an active surveillance protocol (SANO-2 study)
- Age ≥18
- Written, voluntary, informed consent
Exclusion criteria 3
- Patients who were treated with definitive chemoradiotherapy
- Patients who were unable to complete all radiotherapy fractions
- Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Disease-free survival (DFS), defined as the time elapsed between inclusion and locoregional or distant disease recurrence or death, whichever comes first.
Secondary endpoints 3
- Proportion of patients who develop locoregional disease recurrence
- proportion of patients who develop distant metastases
- Serious adverse events and grade 3-4 adverse events from the time of their first treatment with nivolumab according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941375 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 6240 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-packaging and re-labelling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Jessie Huizer
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Jessie Huizer
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 74 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2022-09-29 | 2026-02-11 | 2022-09-29 | 2025-02-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513635-24-00 | 1.5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-12 | Netherlands | Acceptable with conditions 2024-09-30
|
2024-09-30 |