Trial · NCT02576509
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT02576509, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2020-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma. Trials, record NCT02576509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02576509
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
- NCT number
- NCT02576509
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 743 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Nivolumab, Sorafenib
- First posted
- 2015-10-15
- Last updated
- 2025-02-17
- Results first posted
- 2020-06-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months) | OS is defined as the time from the date of randomization to the date of death due to any cause in all randomized participants. Participants who are alive will be censored at the last known alive dates. Based on Kaplan-Meier Estimates. |
| Secondary | Objective Response Rate (ORR) Per BICR RECIST 1.1 | the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months) | ORR is defined as the proportion of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR is defined as the best response designation, as determined based on BICR-assessed tumor response according to RECIST 1.1, recorded between the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For a BOR of CR or PR, the initial response assessment must be confirmed by a consecutive assessment no less than 4 weeks (28 days) later. Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors |
| Secondary | Progression-Free Survival (PFS) | time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months) | PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by BICR according to RECIST 1.1 or death due to any cause in all randomized participants. Participants who die without a reported prior progression and without initiation of subsequent anti-cancer therapy will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have baseline tumor assessment will be censored on the date they were randomized. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to subsequent anti-cancer therapy. |
| Secondary | Efficacy Based on PD-L1 Expression - OS and PFS | the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months) | PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as: Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling. Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate). PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression: * PD-L1 \> X %: ≥ X % PD-L1 expression * PD-L1 \< X %: \< X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored. Confidence interval based on the Clopper and Pearson method. |
| Secondary | Efficacy Based on PD-L1 Expression - ORR | the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months) | PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as: Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling. Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate). PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression: * PD-L1 \> X %: ≥ X % PD-L1 expression * PD-L1 \< X %: \< X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored. Confidence interval based on the Clopper and Pearson method. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months) | all randomized participants | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per BICR RECIST 1.1 | the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months) | all randomized participants | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months) | all randomized participants | Months | MEDIAN |
| SECONDARY | Efficacy Based on PD-L1 Expression - OS and PFS | the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months) | all randomized participants with a \>=1% PD-L1 expression all randomized participants with a \<1% PD-L1 expression all randomized participants without PD-L1 quantifiable | Months | MEDIAN |
| SECONDARY | Efficacy Based on PD-L1 Expression - ORR | the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months) | all randomized participants with a \>=1% PD-L1 expression all randomized participants with a \<1% PD-L1 expression all randomized participants without PD-L1 quantifiable Note: odds ratio for participants without PD-L1 quantifiable cannot be estimated based on the data | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Nivolumab 240 mg | 16.39 | 95% Confidence Interval 13.93 to 18.37 | Months | |
| Overall Survival (OS) | Sorafenib 400 mg | 14.69 | 95% Confidence Interval 11.89 to 17.22 | Months | |
| Objective Response Rate (ORR) Per BICR RECIST 1.1 | Nivolumab 240 mg | 15.4 | 95% Confidence Interval 11.8 to 19.4 | Percentage of participants | |
| Objective Response Rate (ORR) Per BICR RECIST 1.1 | Sorafenib 400 mg | 7.0 | 95% Confidence Interval 4.6 to 10.1 | Percentage of participants | |
| Progression-Free Survival (PFS) | Nivolumab 240 mg | 3.68 | 95% Confidence Interval 3.06 to 3.88 | Months | |
| Progression-Free Survival (PFS) | Sorafenib 400 mg | 3.75 | 95% Confidence Interval 3.71 to 4.47 | Months | |
| Efficacy Based on PD-L1 Expression - OS and PFS | Nivolumab 240 mg | >=1%, OS | 16.07 | 95% Confidence Interval 8.41 to 22.34 | Months |
| Efficacy Based on PD-L1 Expression - OS and PFS | Sorafenib 400 mg | >=1%, OS | 8.62 | 95% Confidence Interval 5.72 to 16.30 | Months |
| Efficacy Based on PD-L1 Expression - OS and PFS | Nivolumab 240 mg | >=1%, PFS | 3.84 | 95% Confidence Interval 2.10 to 7.62 | Months |
| Efficacy Based on PD-L1 Expression - OS and PFS | Sorafenib 400 mg | >=1%, PFS | 3.58 | 95% Confidence Interval 1.97 to 5.36 | Months |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment Period | STARTED | Nivolumab 240 mg | 371 | |
| Pre-Treatment Period | STARTED | Sorafenib 400 mg | 372 | |
| Pre-Treatment Period | COMPLETED | Nivolumab 240 mg | 367 | |
| Pre-Treatment Period | COMPLETED | Sorafenib 400 mg | 363 | |
| Pre-Treatment Period | NOT COMPLETED | Nivolumab 240 mg | 4 | |
| Pre-Treatment Period | NOT COMPLETED | Sorafenib 400 mg | 9 | |
| Treatment Period | STARTED | Nivolumab 240 mg | 367 | |
| Treatment Period | STARTED | Sorafenib 400 mg | 363 | |
| Treatment Period | COMPLETED | Nivolumab 240 mg | 0 | |
| Treatment Period | COMPLETED | Sorafenib 400 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events660
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 | Nivolumab 240 mg | 35 | 367 | |
| other | Anaemia | Blood and lymphatic system disorders | Sorafenib 400 mg | 30 | 363 | |
| other | Hypothyroidism | Endocrine disorders | Nivolumab 240 mg | 29 | 367 | |
| other | Hypothyroidism | Endocrine disorders | Sorafenib 400 mg | 12 | 363 | |
| other | Abdominal distension | Gastrointestinal disorders | Nivolumab 240 mg | 15 | 367 | |
| other | Abdominal distension | Gastrointestinal disorders | Sorafenib 400 mg | 22 | 363 | |
| other | Abdominal pain | Gastrointestinal disorders | Nivolumab 240 mg | 69 | 367 | |
| other | Abdominal pain | Gastrointestinal disorders | Sorafenib 400 mg | 82 | 363 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Nivolumab 240 mg | 42 | 367 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Sorafenib 400 mg | 50 | 363 |
1 to 10 of 660Source ClinicalTrials.gov
See all 660 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab 240 mg | 321 | 371 |
| Total, all-cause mortality | Sorafenib 400 mg | 335 | 372 |
| Total, other adverse events | Nivolumab 240 mg | 339 | 367 |
| Total, other adverse events | Sorafenib 400 mg | 351 | 363 |
| Total, serious adverse events | Nivolumab 240 mg | 216 | 367 |
| Total, serious adverse events | Sorafenib 400 mg | 216 | 363 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nivolumab 240 mg vs Sorafenib 400 mg: deaths from any cause | Trial comparisons |
| Nivolumab 240 mg vs Sorafenib 400 mg: serious adverse events | Trial comparisons |
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/NCT02576509
GET https://conductscience.org/api/trials/v1/NCT02576509/results?page=2