Spots Global Cancer Trial Database for BIOLUMA: Biomarkers for Nivolumab and Ipilimumab and Evaluation of the Combination in Lung Cancer
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Trial Identification
Brief Title: BIOLUMA: Biomarkers for Nivolumab and Ipilimumab and Evaluation of the Combination in Lung Cancer
Official Title: A Phase II Trial of Nivolumab in Combination With Ipilimumab to Evaluate Efficacy and Safety Relapsed in Lung Cancer and to Evaluate Biomarkers Predictive for Response to Immune Checkpoint Inhibition
Study ID: NCT03083691
Study Description
Brief Summary: BIOLUMA is a multicentric non-randomised phase II trial in patients with non-squamous non-small cell lung cancer (NSCLC) (Cohort 1) and patients with small-cell lung cancer (SCLC) (Cohort 2) after failure of platinum-based first-line therapy. NSCLC patients are treated with nivolumab until disease progression and subsequently receive a combination therapy of nivolumab and ipilimumab. SCLC patients receive four cycles of nivolumab in combination with ipilimumab and subsequent nivolumab monotherapy. Primary endpoint for both cohorts is overall response rate of combination therapy. Within the diagnostic part tumor biopsies will be analysed. Tumor tissue will be obtained before initiation of therapy and after progression on nivolumab monotherapy before addition of ipilimumab in Cohort 1 and after completion of the four nivolumab/ipilimumab combination cycles before continuation of nivolumab monotherapy in Cohort 2, respectively. Flow cytometry of blood samples and microbiome analysis of deep rectal swaps are performed prior to therapy as well as during course of treatment. Cohort 1 (NSCLC) is closed for enrollment due to Sponsor decision. In Cohort 2 (SCLC) a prescreening for high Tumor Mutation Burden is necessary before enrollment.
Detailed Description: Cohort 2 (SCLC) has been subdivided by amendment in Cohort 2a without prescreening and Cohort 2b with TMB-prescreening. For Cohort 2a enrollment has been stopped in December 2017. Cohort 2b is closed for enrollment as the cohort is fully recruited.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
SLK-Fachklinik Löwenstein, Löwenstein, Baden-Wuerttemberg, Germany
UniversitĂ€tsklinikum TĂŒbingen, Innere Medizin VIII - Medizinische Onkologie und Pneumologie, TĂŒbingen, Baden-Wuerttemberg, Germany
UniversitĂ€tsklinikum WĂŒrzburg - Comprehensive Cancer Center Mainfranken, WĂŒrzburg, Bavaria, Germany
UniversitÀtsklinikum Frankfurt - Medizinische Klinik II, Frankfurt am Main, Hessen, Germany
Klinikum Kassel - Klinik fĂŒr HĂ€matologie und Onkologie, Kassel, Hessen, Germany
Pius Hospital Oldenburg, Oldenburg, Lower Saxony, Germany
Uniklinik RWTH - Klinik fĂŒr HĂ€matologie, Onkologie, HĂ€mostaseologie und Stammzellentransplantation, Aachen, North Rhine-Westphalia, Germany
UniversitÀtsklinikum Bonn - Medizinische Klinik und Poliklinik III, Bonn, North Rhine-Westphalia, Germany
University Hospital Cologne, Cologne, North Rhine-Westphalia, Germany
Kliniken der Stadt Köln - Lungenkrebszentrum Köln-Merheim, Cologne, North Rhine-Westphalia, Germany
St.-Johannes-Hospital Dortmund, Dortmund, North Rhine-Westphalia, Germany
Uniklinik DĂŒsseldorf - Klinik fĂŒr HĂ€matologie und Onkologie, DĂŒsseldorf, North Rhine-Westphalia, Germany
Lungenklinik Hemer, Hemer, North Rhine-Westphalia, Germany
UniversitĂ€tsklinikum MĂŒnster - Medizinische Klinik A, Pneumologie, MĂŒnster, North Rhine-Westphalia, Germany
Malteser Krankenhaus St. Franziskus-Hospital, Flensburg, Schleswig-Holstein, Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Contact Details
Name: JĂŒrgen Wolf, MD
Affiliation: University ClinicCologne
Role: PRINCIPAL_INVESTIGATOR
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