NCT03168464

Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

NSCLC patients with metastatic disease who have failed at least one prior treatment and have a minimum of two metastatic lesions (at least one measurable), are eligible if they have an ECOG Performance Status of 0-1. Patients will receive on Day 1, ipilimumab (every 6 weeks) concurrently with radiation (6Gy x 5 fractions). Nivolumab (every 2 weeks) will be given in addition to ipilimumab on day 22.

Detailed description

NSCLC patients with metastatic disease who have failed at least one prior treatment and have a minimum of two metastatic lesions (at least one measurable), are eligible if they have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. Non-ablative radiotherapy (6GyX5) is directed to one lesion during a first immunotherapy treatment with Ipilimumab 3 mg/kg (± 24hrs from first RT dose). On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression. Patients are re-imaged at Week 9 (day 70 ± 7) to evaluate for response (defined as an objective response by RECIST of the measurable metastatic sites outside the radiation field). This response will be evaluated assessing clinical and positron emission computed tomography (PET/CT) responses in the non-irradiated measurable metastatic sites using RECIST 1.1.

Conditions

• Non Small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study. On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
DRUG	Nivolumab	On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
RADIATION	Radiation therapy	Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.

Timeline

• Start date: 2017-10-09
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2017-05-30
• Last updated: 2023-04-24
• Results posted: 2023-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study