Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 100
Inclusion Criteria
- Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
- ...
- Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
- Patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation for locally advanced disease
- Men and women ≥18 years of age
Exclusion Criteria
- Carcinomatous meningitis
- A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug
- Prior treatment on either arm of study CA209-017 or CA184-104
- ...
- Carcinomatous meningitis
- A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug
- Prior treatment on either arm of study CA209-017 or CA184-104
- Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
- Untreated central nervous system (CNS) metastases. Metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of ≤10 mg prednisone daily (or equivalent)
- Active known or suspected autoimmune disease or interstitial lung disease
Summary
- Conditions
- Squamous Cell Non-small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
- ...
- Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
- Patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation for locally advanced disease
- Men and women ≥18 years of age
Exclusion Criteria
- Carcinomatous meningitis
- A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug
- Prior treatment on either arm of study CA209-017 or CA184-104
- ...
- Carcinomatous meningitis
- A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug
- Prior treatment on either arm of study CA209-017 or CA184-104
- Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
- Untreated central nervous system (CNS) metastases. Metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of ≤10 mg prednisone daily (or equivalent)
- Active known or suspected autoimmune disease or interstitial lung disease
Tracking Information
- NCT #
- NCT01721759
- Collaborators
- Not Provided
- Investigators
- Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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