Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

Study treatment will consist of BO-112 IT injections in combination with IV nivolumab infusions and SABR to accessible metastases.

BO-112 in combination with ablative radiotherapy (SABR) and nivolumab

Four research biopsies will be taken from accessible injected lesions, at the time of the IT injection of BO-112.

Tissue Biopsies

María E Rodríguez Ruiz

María E Rodríguez, MD

Maria E Rodriguez, PhD

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.

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.

This is a phase Ib/II study with one single treatment arm (BO-112 in combination with SABR and nivolumab)

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

Number and proportion of subjects with TEAEs with severity ≥ Grade 3 (NCI-CTCAE v. 5.0)

Number and proportion of subjects with study treatment-related TEAEs Grade ≥3, number and proportion of subjects with TEAEs (any grade); number and proportion of subjects with related TEAEs (any grade).

t Time from C1D1 to the first occurrence of disease progression or death from any cause

ORR based on the best overall response (BOR); disease control rate (DCR = CR, PR and SD of at least 12 weeks duration) on the global tumor assessment in ITT population.

* DCR = iCR, iPR + iSD of at least 12 weeks duration) in ITT population.
* Overall survival rate at 12 months.

Number of study discontinuations due to related TEAE.

Spots Global Cancer Trial Database for bo112

Every month we try and update this database with for bo112 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bo112

Every month we try and update this database with for bo112 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bo112 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.