Trial results for a Phase 1/2 study (NCT04021043) investigating nivolumab, ipilimumab, and BMS-986156, with or without stereotactic body radiation therapy (SBRT), in patients with advanced or metastatic lung/chest or liver cancers were posted on ClinicalTrials.gov on 2025-12-03. The study reported a low number of dose-limiting toxicities (DLTs), with 0 to 1 DLT observed across the different treatment arms.
Background
The trial investigated combination therapies for patients with advanced malignant solid neoplasm, metastatic carcinoma in the liver, metastatic carcinoma in the lung, metastatic malignant neoplasm in the thoracic cavity, and metastatic malignant solid neoplasm. The study explored the safety and efficacy of anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) agonistic monoclonal antibody BMS-986156 in combination with ipilimumab and nivolumab, with or without stereotactic body radiation therapy.
Trial design
The Phase 1/2 trial (NCT04021043) was a completed study that enrolled 51 participants. It investigated BMS-986156, ipilimumab, and nivolumab with or without stereotactic body radiation therapy (SBRT) in patients with advanced or metastatic lung/chest or liver cancers. The conditions studied included advanced malignant solid neoplasm, metastatic carcinoma in the liver, metastatic carcinoma in the lung, metastatic malignant neoplasm in the thoracic cavity, and metastatic malignant solid neoplasm. The trial aimed to assess the side effects and optimal dose of the combination therapies.
Key results
The trial's key measurements focused on the number of dose-limiting toxicities (DLTs) and the completion of SBRT and palliative radiation. Regarding DLTs:
- In the Ipilimumab + BMS-986156 Arm (30 mg/kg), there was 1 dose-limiting toxicity.
- In the Ipilimumab + BMS-986156 Arm (100 mg/kg), there was 1 dose-limiting toxicity.
- In the Ipilimumab + BMS-986156 With SBRT Arm, there were 0 dose-limiting toxicities.
- In the Nivolumab + BMS-986156 With SBRT Arm, there were 0 dose-limiting toxicities.
For the outcome of 'Assess SBRT and Palliative Radiation Completion':
- In the Ipilimumab + BMS-986156 With SBRT Arm, the counts of participants for this outcome were 10, 0, 0, and 2.
- In the Nivolumab + BMS-986156 With SBRT Arm, the counts of participants for this outcome were 20, 4, 3, and 5.
What this means
The low number of dose-limiting toxicities observed across all treatment arms suggests a potentially manageable safety profile for the combination of BMS-986156 with ipilimumab or nivolumab, both with and without SBRT, in patients with advanced or metastatic lung/chest or liver cancers. These findings are important for understanding the safety aspects of these complex immunotherapy regimens in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04021043, titled 'BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers,' were posted on 2025-12-03 on clinicaltrials.gov.