Advanced Non-Small Cell Lung Cancer Progressing After at Least One Prior Therapy For Metastatic Disease

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
howard safran
Study ID
NCT02469701
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Nivolumab releases the inhibition of the immune system against human cancers. Dramatic and sustained activity has been observed in advanced lung cancer. Ablation may stimulate the immune system by exposing new tumor antigens. Since tumors that express PD-L1 may be more likely to respond to nivolumab, if ablation increases PD-L1 expression (which has not been studied) this treatment may enhance the activity of nivolumab at both the treated site and in other, non-treated, tumors. Ablation is already an FDA approved treatment for cancer. Nivolumab was recently FDA approved for second line treatment of advanced squamous cell NSCLC. The goal of the study will be to determine if the combination of nivolumab and ablation has higher systemic activity than previously reported with nivolumab alone.

Key Dates

Start date
Feb 29, 2016
Status verified
Feb 2020
Primary completion
Jul 31, 2017
Completion
Mar 31, 2018

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab with ablation
    3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years. Either cryoablation or thermal ablation may be performed as per standard institutional policies. As of amendment # 7 submitted to sites November 17, 2017, the dosing for Nivolumab per the FDA guidance was amended to a flat dose of 240mg IV Q2 weeks. As of amendment #8 sent to sites February 22, 2017 the dose of Nivolumab was updated to 3 mg/kg with a maximum dose of 240 mg for patients with weights that would correlate to exceed that dose instead of a flat dose secondary to the standard institutional practice and the FDA guidance .

Primary Outcome Measure

Response Rate of the Combination of Ablation and the PD-1 Inhibitor Nivolumab for Patients With Non-small Cell Lung Cancer (NSCLC) Who Have Progressed Following at Least 1 Prior Chemotherapy Regimen for Metastatic or Locally Advanced Disease. [ Time Frame: Up to 5 years. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02903-
The Miriam HospitalProvidenceRhode Island02906-

Find similar trials in Providence, RI

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Rhode Island Hospital· Providence, RIThe Miriam Hospital· Providence, RI

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