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NCT02743494 | SNCTP000001972

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 07.04.2020), WHO (Imported from 22.03.2020)
Changed: 26.03.2020
Disease category: Anderer Krebs

Brief description of trial (Source of data: 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 (Source of data: BASEC)

Patienten mit reseziertem Ösophaguskarzinom, oder Karzinom des gastroösophagealen Übergangs

Health conditions (Source of data: WHO)

Advanced Cancer

Rare disease (Source of data: BASEC)

Yes

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Medikament: Nivolumab, Opdivo

Interventions (Source of data: WHO)

Drug: Nivolumab;Other: Placebo

Criteria for participation in trial (Source of data: 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 (Source of data: BASEC)

- Patienten mit diagnostiziertem zervikalem Ösophaguskarzinom
- Patienten mit diagnostizierter, resezierbarer Grad IV Erkrankung
- Patienten, die keine preoperative begleitende Radiochemotherapie erhielten

Inclusion/Exclusion Criteria (Source of data: 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 (Source of data: 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 (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).

Phase (Source of data: WHO)

Phase 3

Primary end point (Source of data: 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 (Source of data: WHO)

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

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Basel, St Gallen

Countries (Source of data: 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 (Source of data: BASEC)

Dr. med. Christian Weisshaupt
+41 71 494 26 92
Christian.Weisshaupt@kssg.ch

Contact for general information (Source of data: WHO)

Bristol-Myers Squibb
Bristol-Myers Squibb

Contact for scientific information (Source of data: WHO)

Bristol-Myers Squibb
Bristol-Myers Squibb

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Bristol-Myers Squibb

Additional sponsors (Source of data : WHO)

Ono Pharmaceutical Co. Ltd

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2016-01266

Secondary ID (Source of data: WHO)

2015-005556-10;CA209-577