Trial · NCT01454102
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)
NCT01454102, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2019-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT01454102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01454102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT01454102
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 472 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Nivolumab, Gemcitabine, Cisplatin, Pemetrexed, Paclitaxel, Carboplatin, Bevacizumab, Erlotinib, Ipilimumab
- First posted
- 2011-10-18
- Last updated
- 2021-10-12
- Results first posted
- 2019-08-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months) | 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. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. |
| Primary | Number of Participants Who Experienced Selected Adverse Events | From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months) | The number of participants who experienced an AE of interest due to any cause is presented. Endocrine, Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, and Hypersensitivity/Infusion select AEs were identified that are potentially associated with the use of nivolumab, based on the following 4 guiding principles: * AEs that may differ in type, frequency, or severity from AEs caused by non-immunotherapies * AEs that may require immunosuppression (eg, corticosteroids) as part of their management * AEs whose early recognition and management may mitigate severe toxicity * AEs for which multiple event terms may be used to describe a single type of AE, thereby necessitating the pooling of terms for full characterization. |
| Primary | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months) | The number of subjects with selected hepatic laboratory abnormalities is reported. AST= aspartate aminotransferase; ALT= alanine aminotransferase; ULN= upper limit of normal. |
| Primary | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months) | The number of subjects with selected thyroid laboratory abnormalities is reported. FT3 and FT4 test abnormalities were considered for a 2-week window after the abnormal TSH test date. TSH= thyroid-stimulating hormone; FT3= Free T3; FT4= Free T4; LLN= lower limit of normal; ULN= upper limit of normal |
| Secondary | Objective Response Rate (ORR) | From first dose until date of progression or subsequent anti-cancer therapy (assessed up to July 2016, approximately 55 months) | ORR was defined as the percentage of all treated participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria as per investigator assessment. This proportion was multiplied by 100 and expressed as a percentage. BOR was defined as the best response designation recorded between the date of randomization and the date of progression, or the date of subsequent anticancer therapy, whichever occurred first. CR or PR determinations included in the BOR assessment were confirmed by a second scan at least 4 weeks after the criteria for responses were first met. For participants without progression or subsequent therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial progression. |
| Secondary | Progression-Free Survival Rate (PFSR) at Week 24 | 24 weeks | Progression-Free Survival (PFS) was defined as the time from the date of first dose of study medication to the date of first disease progression or death, if death occurred within 100 days of the final dose of study drug. Among participants without previous RECIST-defined progression, participants who died beyond 100 days and those who remained alive were censored at the last tumor assessment date (before subsequent therapy). PFSR at week 24 was defined as the proportion of subjects remaining progression free and surviving at 24 weeks. The proportion was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data, and expressed as a percentage. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Selected Adverse Events | From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months) | All treated participants with baseline and post-baseline measurements | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months) | All treated participants with baseline and post-baseline measurements | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | From first dose until date of progression or subsequent anti-cancer therapy (assessed up to July 2016, approximately 55 months) | All treated participants | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival Rate (PFSR) at Week 24 | 24 weeks | All treated participants | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group464
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm A: Nivolumab + Gemcitabine + Cisplatin | SAEs | 4 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm B: Nivolumab + Pemetrexed + Cisplatin | SAEs | 10 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm C10: Nivolumab + Paclitaxel + Carboplatin | SAEs | 8 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm D: Nivolumab + Bevacizumab Maintenance | SAEs | 3 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm E: Nivolumab + Erlotinib | SAEs | 11 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm F: Nivolumab | SAEs | 23 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm GH: Nivolumab + Ipilimumab | SAEs | 18 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm IJ: Nivolumab + Ipilimumab | SAEs | 17 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | SAEs | 3 | Participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | SAEs | 4 | Participants |
1 to 10 of 464Source ClinicalTrials.gov
See all 464 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Nivolumab + Gemcitabine + Cisplatin | 12 | |
| Overall Study | STARTED | Arm B: Nivolumab + Pemetrexed + Cisplatin | 15 | |
| Overall Study | STARTED | Arm C10: Nivolumab + Paclitaxel + Carboplatin | 15 | |
| Overall Study | STARTED | Arm D: Nivolumab + Bevacizumab Maintenance | 12 | |
| Overall Study | STARTED | Arm E: Nivolumab + Erlotinib | 21 | |
| Overall Study | STARTED | Arm F: Nivolumab | 52 | |
| Overall Study | STARTED | Arm GH: Nivolumab + Ipilimumab | 24 | |
| Overall Study | STARTED | Arm IJ: Nivolumab + Ipilimumab | 25 | |
| Overall Study | STARTED | Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | 13 | |
| Overall Study | STARTED | Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | 13 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events8,721
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Nivolumab + Gemcitabine + Cisplatin | 8 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm J: Nivolumab + Ipilimumab | 1 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm K: Nivolumab In Squamous Histology Subjects (NSCLC) | 1 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC) | 0 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm M: Nivolumab | 0 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm N: Nivolumab + Ipilimumab | 4 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm O: Nivolumab + Ipilimumab | 5 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm P: Nivolumab + Ipilimumab | 6 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm Q: Nivolumab + Ipilimumab | 5 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Nivolumab + Pemetrexed + Cisplatin | 2 | 15 |
1 to 10 of 8,721Source ClinicalTrials.gov
See all 8,721 adverse eventsAdverse event totals51
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Nivolumab + Gemcitabine + Cisplatin | ||
| Total, all-cause mortality | Arm J: Nivolumab + Ipilimumab | ||
| Total, all-cause mortality | Arm K: Nivolumab In Squamous Histology Subjects (NSCLC) | ||
| Total, all-cause mortality | Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC) | ||
| Total, all-cause mortality | Arm M: Nivolumab | ||
| Total, all-cause mortality | Arm N: Nivolumab + Ipilimumab | ||
| Total, all-cause mortality | Arm O: Nivolumab + Ipilimumab | ||
| Total, all-cause mortality | Arm P: Nivolumab + Ipilimumab | ||
| Total, all-cause mortality | Arm Q: Nivolumab + Ipilimumab | ||
| Total, all-cause mortality | Arm B: Nivolumab + Pemetrexed + Cisplatin |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01454102
GET https://conductscience.org/api/trials/v1/NCT01454102/results?page=2