Study of BO-112 With Radiotherapy and Nivolumab for Metastatic Refractory NSCLC
NCT05265650 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-07-19
Summary
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.
Conditions
- Non-Small Cell Lung Cancer Metastatic
Interventions
- DRUG
-
BO-112 in combination with ablative radiotherapy (SABR) and nivolumab
Study treatment will consist of BO-112 IT injections in combination with IV nivolumab infusions and SABR to accessible metastases.
- PROCEDURE
-
Tissue Biopsies
Four research biopsies will be taken from accessible injected lesions, at the time of the IT injection of BO-112.
Sponsors & Collaborators
-
Highlight Therapeutics
collaborator INDUSTRY -
Clinica Universidad de Navarra, Universidad de Navarra
lead OTHER
Principal Investigators
-
Maria E Rodriguez, PhD · Clinica Universidad de Navarra
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-13
- Primary Completion
- 2024-03-31
- Completion
- 2024-06-30
Countries
- Spain
Study Locations
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