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SNCTP000001972 | NCT02743494 | BASEC2016-01266

Eine randomisierte, multizentrische, doppelblinde Phase-lll-Studie zu adjuvantem Nivolumab oder Placebo bei Patienten mit reseziertem Ösophaguskarzinom oder Karzinom des gastroösophagealen Übergangs.

Data source: BASEC (Imported from 03.07.2020), WHO (Imported from 05.07.2020)
Changed: 28.06.2020
Disease category: Other Cancer

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)

Yes

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)


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 the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02743494

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02743494

Further information on trial

Date trial registered

15.04.2016

Incorporation of the first participant

23.05.2016

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 of adjuvant nivolumab in participants with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery

Secundary end point (Data source: WHO)

Overall survival rate;Overall Survival of adjuvant nivolumab in participants with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

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

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Bristol-Myers Squibb

Additional sponsors (Data source: WHO)

Ono Pharmaceutical Co. Ltd

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