BrUOG 317:Nivolumab and Ablation For Patients With Advanced Non-Small Cell Lung Cancer Progressing After at Least One Prior Therapy For Metastatic Disease
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/8/2018 |
| Start Date: | February 2016 |
| End Date: | March 2018 |
BrUOG L317: Nivolumab and Ablation For Patients With Advanced Non-Small Cell Lung Cancer Progressing After at Least One Prior Therapy For Metastatic Disease: A Brown University Oncology Research Group Phase II Study
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.
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.
Inclusion Criteria:
- Pathologically or cytologically confirmed NSCLC
- Stage IIIB or stage IV.
- Patient to meet either criterion A or B:
A) Progression after at least 1 line of systemic treatment (IV or oral) for metastatic or
locally advanced disease. Must provide documentation systemic treatment was for either
locally advanced or metastatic and also scan or assessment to show progression. Radiation
does not count as 1 line.
B) Patients progressing within 6 months of completion of neoadjuvant or adjuvant
chemotherapy are also eligible without having treatment for metastatic disease (for example
patient with stage I disease undergoes resection, receives systemic chemotherapy and then
progresses to the liver (now stage IV) within 6 months of chemotherapy). Radiation does not
count as 1 line.
- Ablation for advanced lung cancer is being considered by the treating physician for
treatment or prevention of symptoms such as pain, bleeding or obstruction-
Documentation is required in writing by MD for this criterion.
- At least 1 site of measurable disease that will not be treated with ablation. Sites to
send confirmation on which lesion of measurable disease will not be ablated for
tracking of response.
- At least 3 weeks since prior chemotherapy and radiation therapy
- No brain metastases except for patients whose metastases have been removed by surgical
resection or have had stereotactic radiation or gamma knife with no evidence of active
disease on MRI within 28 days of starting treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy of at least 12 weeks.
- Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥
1000/µl; platelet count ≥75,000/µl; absolute lymphocyte count ≥ 500/ µl; Creatinine ≤
1.5x upper limit normal mg/dl; Bilirubin < 1.5x upper limit normal; AST ≤ 3 x upper
limit of normal.
- Age > 18 years
- Men and women of childbearing potential enrolled in this study must agree to use
adequate barrier birth control measures during the course of the study and up to 2
months after.
- Written informed consent.
Exclusion Criteria:
- Patients with a history of clinically significant chronic autoimmune disease
- Prior therapy with antibodies that modulate T-cell function defined as anti-CTLA-4,
anti-PD-1, and anti-PD-L1
- Conditions currently requiring immunosuppressive medications
- Known history of HIV or hepatitis B or C
- Bleeding diathesis or coagulopathy that in the investigators opinion would prevent
ablation from being safely performed.
- Patients with unstable angina (anginal symptoms at rest) or new-onset angina (began
within the last 3 months) or myocardial infarction within the past 6 months.
- History of organ allograft even if not taking immunosuppressive medications
- Pregnant or breast-feeding.
We found this trial at
2
sites
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Howard Safran, MD
Phone: 401-863-3000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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