Brief description of trial (Data source: BASEC)
Der Zweck dieser Studie ist zu untersuchen, ob Nivolumab im Vergleich zu Placebo das Gesamtuberleben, das krankheitsfreie Oberleben oder beides verbessert.
Health conditions investigated(Data source: BASEC)
Patienten mit reseziertem Ösophaguskarzinom, oder Karzinom des gastroösophagealen Übergangs
Health conditions
(Data source: WHO)
Advanced Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Medikament: Nivolumab, Opdivo
Interventions
(Data source: WHO)
Drug: Nivolumab;Other: Placebo
Criteria for participation in trial
(Data source: BASEC)
- Patienten mit diagnostiziertem Grad II/III Ösophaguskarzinom, oder Karzinom des gastroösophagealen Übergangs
- Patienten mit abgeschlossener praoperativer Radiochemotherapie gefolgt von einer Operation
- Patienten, die nach einer vollständigen Entfernung mit negativen Resektionsrand, als chirurgisch krankheitsfrei eingestuft wurden und bei denen anschließend eine pathologische Resterkrankung festgestellt wurde
Exclusion criteria
(Data source: BASEC)
- Patienten mit diagnostiziertem zervikalem Ösophaguskarzinom
- Patienten mit diagnostizierter, resezierbarer Grad IV Erkrankung
- Patienten, die keine preoperative begleitende Radiochemotherapie erhielten
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
- Completed pre-operative chemo radiotherapy followed by surgery
- Diagnosed with residual pathologic disease after being surgically rendered free of
disease with negative margins following complete resection
Exclusion Criteria:
- Diagnosed with cervical esophageal carcinoma
- Diagnosed with Stage IV resectable disease
- Did not receive concurrent chemoradiotherapy prior to surgery
- Participants who have received a live/attenuated vaccine within 30 days of the first
treatment
Other protocol defined Inclusion/exclusion criteria could apply
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Disease-free Survival (DFS)
Secundary end point
(Data source: WHO)
Overall Survival (OS);Overall Survival Rate
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, St. Gallen
Countries
(Data source: WHO)
Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, Peru, Poland, Puerto Rico, Republic of, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. med. Christian Weisshaupt
+41 71 494 26 92
Christian.Weisshaupt@kssg.ch
Contact for general information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Contact for scientific information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
04.10.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-01266
Secondary ID (Data source: WHO)
2015-005556-10
CA209-577
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