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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: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01454102 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 472 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (687% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grad
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 |
What the finished NCT01454102 record still lists
NCT01454102 is an interventional study that assigns participants to a tested intervention. The registered 472 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (687% higher).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT01454102 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01454102's enrollment target sits among peer trials
472 52nd of 2000 higher than 1,949 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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