NCT05265650

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

Phase Ib/II Open-label Clinical Study of Intratumoral Administration of BO-112 in Combination With Radiotherapy and Nivolumab in Patients With Metastatic PD- 1/PD-L1 Refractory Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase Ib/II study to evaluate feasibility-efficacy of repeated 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. To be eligible, all patients must have metastatic NSCLC with at least one accessible lesion amenable to IT BO-112 injection and radiotherapy administration. The study will include an initial cohort A using a standard "3+3" design to determine the safety profile of SABR in combination with BO-112 and nivolumab, which will start on cycle 4 (week 7) and a cohort B, with the same combination but with nivolumab starting on cycle 3 (week 5). 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. On the liver, the maximum frequency for IT injection will be every 2 weeks since the first administration. After the first cycle, BO-112 will continue to be IT injected every 2 weeks on the previously treated lesions provide they are still injectable. A maximum of 2 hepatic lesions will be treated with BO-112 at each cycle and a maximum of 5 multisite tumoral lesion in total. 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. Distribution of volume of injection will be determined based on the size of lesion to be injected. Stereotactic ablative radiotherapy (SABR) will be initiated on week 3. Patients will be evaluated for DLTs until 28 days after the first dose of nivolumab. In 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.

Conditions

• Non-Small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-03-01
• Completion: 2024-06-01
• First posted: 2022-03-03
• Last updated: 2022-07-19

Locations

1 site across 1 country: Spain