Brief description of trial (Data source: BASEC)
Eine Studie zur Einschätzung der Sicherheit von Nivolumab, das in Kombination mit Ipilimumab bei Patienten mit nicht-kleinzelligem Lungenkarzinom (NSCLC) verabreicht wird. In Kohorte A werden Patienten mit neu-diagnostiziertem Stadium 4 oder wiederkehrendem nicht-kleinzelligem Lungenkarzinom eingeschlossen. In Kohorte B werden vorbehandelte Patienten mit Stadium 4 oder wiederkehrendem nicht-kleinzelligem Lungenkarzinom eingeschlossen.
Health conditions investigated(Data source: BASEC)
Nicht-kleinzelliges Lungenkarzinom (NSCLC)
Health conditions
(Data source: WHO)
Lung Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Nivolumab, Opdivo /
Ipilimumab, Yervoy
Interventions
(Data source: WHO)
Drug: Nivolumab in combination with Ipilimumab
Criteria for participation in trial
(Data source: BASEC)
• Histologisch bestätigtes Stadium 4 oder wiederkehrendes Nicht-kleinzelliges Lungenkarzinom
• ECOG Grad 01 (körperlich dazu in der Lage leichte Hausarbeit oder Büroarbeit durchzuführen bis zu voller Aktivität wie vor der Krebserkrankung)
• Keine vorhergehende systemische Krebstherapie (EGFR und ALK Inhibitoren eingeschlossen)
• Gewebe oder PDL1 Ergebnisse verfügbar
Exclusion criteria
(Data source: BASEC)
• Unbehandelte Gehirnmetastasen
• Eine aktive bösartige Erkrankungen, die gleichzeitiger Behandlung bedarf
• Aktive, bekannte oder vermutete Autoimmunerkrankung
• Karzinomatöse Meningitis, dies bedeutet, dass der Krebs eine Entzündung der Gehirnhäute verursacht hat
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out
light housework or office work through to being fully active as you were before
cancer)
- No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
- Tissue or Programmed death-ligand 1 (PD-L1) results available
Cohort 1A Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) score 2 or
- Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria
as listed in the protocol
Cohort C Inclusion Criteria:
- High Tumor Mutation Burden
Exclusion Criteria:
- Untreated brain metastases
- An active malignancy that requires concurrent intervention
- Active, known or suspected autoimmune disease
- Carcinomatous meningitis, which means there is inflammation of the covering of the
brain, caused by cancer
Other protocol-defined inclusion/exclusion criteria apply
-
Further information on trial
Date trial registered
Aug 12, 2016
Incorporation of the first participant
Oct 5, 2016
Recruitment status
Not recruiting
Academic title
(Data source: WHO)
A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 4
Primary end point
(Data source: WHO)
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)
Secundary end point
(Data source: WHO)
Progression Free Survival (PFS)
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
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, Zurich
Countries
(Data source: WHO)
Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Czechia, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Switzerland, Turkey, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
PD Dr. med. Dr. phil. nat. Sacha Rothschild
+41 61 265 50 74/59
sacha.rothschild@usb.ch
Contact for general 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 Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
28.11.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-01708
Secondary ID (Data source: WHO)
2016-002621-10
CA209-817
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