Study of BO-112 With Radiotherapy and Nivolumab for Metastatic Refractory NSCLC

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Study ID
NCT05265650
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Non-Small Cell Lung Cancer Metastatic

Eligibility Criteria

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

Interventions

  • BO-112 in combination with ablative radiotherapy (SABR) and nivolumab — DRUG
    Study treatment will consist of BO-112 IT injections in combination with IV nivolumab infusions and SABR to accessible metastases.
  • Tissue Biopsies — PROCEDURE
    Four research biopsies will be taken from accessible injected lesions, at the time of the IT injection of BO-112.

Study Details

This is a study of repeated IT administrations of BO-112 in combination with ablative radiotherapy (SABR) and concurrent nivolumab in patients with metastatic PD-1/PD-L1-refractory NSCLC.

Key Dates

Start date
Jun 13, 2022
Status verified
Jul 2022
Primary completion
Mar 31, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Treatment Arm
    Treatment will consist of IT administrations of BO-112 in combination with ablative radiotherapy (SABR) and concurrent with systemic administration of nivolumab in patients with metastatic PD-1/PD-L1-refractory NSCLC. In the initial cohort A, BO-112 will be IT injected on a weekly basis during the first cycle on the accessible lesions, and every 2 weeks thereafter. The minimum dose to be injected per visit is 1 mg (unless injected lesion in case of response, if solitary, becomes smaller than 1.5 cm) and the maximum dose is 2 mg (3.4 mL), distributed in the different lesions. Stereotactic ablative radiotherapy (SABR) will be initiated on week 3. In the cohort B, BO-112 and SABR will be administered as described previously. Nivolumab will be administered at the dose of 240 mg every 2 weeks in both cohorts, starting at cycle 4 (week 7) in cohort A and at cycle 3 (week 5) in cohort B.

Primary Outcome Measure

Incidence of Adverse events and Serious Adverse Events [ Time Frame: Throughout study completion, an average of 1 year ]

Central Contacts

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