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NCT01454102 · ClinicalTrials.gov registry record · Phase 1
Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 472
- Enrollment target
NCT01454102 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 472 participants.
The verdict
NCT01454102, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 472 participants
- Enrollment target
Study Summary
* The study is evaluating the safety and tolerability of Nivolumab (BMS-936558) when combined with three platinum-based doublet chemotherapy regimens (Cisplatin/Gemcitabine; Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in subjects with NSCLC. * The study is evaluating the safety and tolerability of Nivolumab as maintenance therapy in combination with Bevacizumab/Avastin that will be given after at least 4 cycles of platinum doublet chemotherapy. * The study is evaluating the safety and tolerability of Nivolumab in combination with Erlotinib among epidermal growth factor receptor (EGFR) mutation positive non-squamous NSCLC subjects and as monotherapy in subjects with NSCLC. * The study is evaluating the safety and tolerability of Nivolumab in combination with Ipilimumab in subjects with squamous and non-squamous NSCLC. * The study is evaluating the safety and tolerability of Nivolumab as switch maintenance therapy in subjects with squamous and non-squamous NSCLC. * The study is evaluating the safety and tolerability of Nivolumab as monotherapy among subjects with untreated, asymptomatic brain metastases and no evidence of cerebral edema.
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Paclitaxel
- DRUG Gemcitabine
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 472 participants |
| Start Date | 2011-12-16 |
| Est. Completion | 2021-07-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01454102
The ClinicalTrials.gov registry entry for NCT01454102 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 472 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT01454102 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01454102 about?
NCT01454102 is a clinical study titled "Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)". * The study is evaluating the safety and tolerability of Nivolumab (BMS-936558) when combined with three platinum-based doublet chemotherapy regimens (Cisplatin/Gemcitabine; Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in subjects with NSCLC. * The study is evaluating the safety and tolerabilit...
What is the current status of trial NCT01454102?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 472 participants. The study started on 2011-12-16. Estimated completion is 2021-07-23.
What interventions are being tested in trial NCT01454102?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), Paclitaxel (DRUG), Gemcitabine (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01454102?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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