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

NCT03168464 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-04-24

Study results available
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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.

Conditions

  • Non Small Cell Lung Cancer Metastatic

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Silvia Formenti, M.D. · Weill Cornell Medicine New York Prebyterian hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2022-03-11
Completion
2022-03-11
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168464 on ClinicalTrials.gov