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

Sponsor
Lung Cancer Group Cologne
Study ID
NCT03083691
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 13, 2017
Status verified
Jan 2024
Primary completion
Aug 31, 2022
Completion
Nov 20, 2023

Study Design

Enrollment
90 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Cohort 1, NSCLC
    During Treatment Part A nivolumab 240 mg IV q2w as monotherapy is administered. At the time of disease progression a re-biopsy is performed before initiation of combination therapy (Treatment Part B). Within Treatment Part B, nivolumab is given in a dose of 3 mg/kg q2w together with ipilimumab 1 mg/kg IV q6w.
  • Other: Cohort 2, SCLC
    Within Treatment Part A, nivolumab 1 mg/kg q3w together with ipilimumab 3 mg/kg q3w for a total of four doses is administered. After the four combined doses have been administered, a re-biopsy is performed before initiation of Treatment Part B. In Treatment Part B, nivolumab 240 mg q2w monotherapy is administered until disease progression or unacceptable toxicity

Primary Outcome Measure

Cohort 1: ORR after addition of ipilimumab to nivolumab treatment. [ Time Frame: From beginning of combination therapy until the date of first documented progression, or date of death of any cause, whichever occurs first, assessed up to 120 months. ]

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