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SNCTP000002154 | NCT02869789 | BASEC2016-01708

Eine Sicherheits- und Wirksamkeitsstudie von Nivolumab in Kombination mit Ipilimumab zur Behandlung von nicht-kleinzelligem Lungenkarzinom (NSCLC)

Data source: BASEC (Imported from 05.03.2021), WHO (Imported from 07.03.2021)
Changed: 23.02.2021
Disease category: Lung Cancer

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)


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

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 could apply

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02869789

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02869789

Further information on trial

Date trial registered

12.08.2016

Incorporation of the first participant

05.10.2016

Recruitment status

Active, 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 who experience high grade AEs (Adverse Events);Percentage of participants who experience high grade AEs

Secundary end point (Data source: WHO)

Overall Survival (OS);Functional Assessment of Cancer Therapy-Lung (FACT-L);Duration of Response (DOR);ORR;Progression-free survival (PFS)

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, 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

Contact for scientific information (Data source: WHO)

Bristol-Myers Squibb
Bristol-Myers Squibb

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

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