NCT03083691

BIOLUMA: Biomarkers for Nivolumab and Ipilimumab and Evaluation of the Combination in Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Lung Cancer Group Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Small Cell Lung

Interventions

Type	Name	Description
DRUG	Nivolumab, Ipilimumab	Cohort 1: addition of ipilimumab in case of progression on nivolumab monotherapy.
DRUG	Nivolumab, Ipilimumab	Cohort 2: upfront combination therapy of nivolumab and ipilimumab for four cycles, followed by nivolumab monotherapy.

Timeline

• Start date: 2017-04-13
• Primary completion: 2022-08-31
• Completion: 2023-11-20
• First posted: 2017-03-20
• Last updated: 2024-01-17

Locations

16 sites across 1 country: Germany