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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
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.
Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.
Weill Cornell Medicine
New York, New York, United States
Enhance Overall Response Rate (ORR) to the Combination of Ipi/Nivo in Chemo-refractory NSCLC and Double the ORR of Ipi/RT, From 18% Based on Intent to Treat to 36%.
To enhance the ORR to the combination of Ipi/Nivo in chemo-refractory NSCLC by preceding it with a combination of Ipi/RT to convert the irradiated tumor into an in situ vaccine and to double the ORR of Ipi/RT, from 18% based on intent to treat to 36%.
Time frame: 2.5 Months, 6 Months, 3 years
Changes in T-cell Receptor (TCR) Repertoire in Peripheral Blood Are Associated With Response to Treatment
changes in T-cell receptor (TCR) repertoire in peripheral blood are associated with response to treatment
Time frame: 4 years
Serum Markers IFN-b, CXCL11, sMICA, sMICB Levels/Changes Associated With Patients' Response to the Treatment.
serum markers interferon-beta(IFN-B), C-X-C motif chemokine 11(CXCL11), soluble major histocompatibility complex class I-related chain A(sMICA), soluble major histocompatibility complex class I-related chain B (sMICB) levels/changes associated with patients' response to the treatment
Time frame: 4 years
Associations of Overall Response Rate (ORR) With Changes in the Microbiome
associations of ORR with changes in the microbiome
Time frame: 4 years
Progression Free Survival
Patients will be followed for progression free survival.
Time frame: 4 years
Patients' Time to Progression Will be Assessed in This Study.
Patients' time to progression will be assessed in this study.
Time frame: 3 years
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Patients' Duration of Response (DOR) Will be Assessed in This Study.
Patients' duration of response (DOR) will be assessed in this study.
Time frame: 3 years
Overall Survival (OS)
Patients will be followed for overall survival.
Time frame: 4 years