NCT04151563
Withdrawn
Phase 1
A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy
ConditionsCarcinoma, Non-small Cell Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- nivolumab
- Conditions
- Carcinoma, Non-small Cell Lung Cancer
- Sponsor
- Bristol-Myers Squibb
- Locations
- 1
- Primary Endpoint
- Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm C: nivolumab + ramucirumab + docetaxel
Intervention: nivolumab
Arm C: nivolumab + ramucirumab + docetaxel
Intervention: docetaxel
Arm C: nivolumab + ramucirumab + docetaxel
Intervention: ramucirumab
Arm A: cabozantinib + nivolumab + ipilimumab
Intervention: nivolumab
Arm A: cabozantinib + nivolumab + ipilimumab
Intervention: ipilimumab
Arm A: cabozantinib + nivolumab + ipilimumab
Intervention: cabozantinib
Arm B: cabozantinib + nivolumab
Intervention: nivolumab
Arm B: cabozantinib + nivolumab
Intervention: cabozantinib
Arm D: lucitanib + nivolumab
Intervention: nivolumab
Arm D: lucitanib + nivolumab
Intervention: lucitanib
Arm E: nivolumab + docetaxel
Intervention: nivolumab
Arm E: nivolumab + docetaxel
Intervention: docetaxel
Arm F: docetaxel
Intervention: docetaxel
Outcomes
Primary Outcomes
Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
Time Frame: approximately 33 months
Secondary Outcomes
- Incidence of Adverse Events (AEs)(Up to 5 Years)
- Incidence of Select AEs(Up to 5 Years)
- Duration of Response (DOR) by BICR using RECIST 1.1(approximately 33 months)
- Progression-Free Survival (PFS) by BICR using RECIST 1.1(Up to 5 Years)
- Incidence of Serious Adverse Events (SAEs)(Up to 5 Years)
- Overall Survival (OS)(Up to 5 Years)
Study Sites (1)
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