Trial · NCT01928394
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
NCT01928394, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2020-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors. Trials, record NCT01928394. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01928394
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
- NCT number
- NCT01928394
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 1,163 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced or Metastatic Solid Tumors
- Interventions
- Nivolumab, Ipilimumab, Cobimetinib
- First posted
- 2013-08-23
- Last updated
- 2024-12-27
- Other registries' IDs
- eudract:2013-002844-10
- Results first posted
- 2020-03-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate ( ORR ) | 60 months | The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate ( ORR ) | 60 months | All Treated Participants | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate ( ORR ) | TNBC Arm N | 5.6 | 95% Confidence Interval 0.1 to 27.3 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | TNBC Arm N-I Dose Level 1 | 0.0 | 95% Confidence Interval 0.0 to 70.8 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | TNBC Arm N-I Dose Level 2 | 0.0 | 95% Confidence Interval 0.0 to 18.5 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | GC Arm N | 11.9 | 95% Confidence Interval 4.9 to 22.9 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | GC Arm N-I Dose Level 1 | 0.0 | 95% Confidence Interval 0.0 to 70.8 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | GC Arm N-I Dose Level 2 | 24.5 | 95% Confidence Interval 13.3 to 38.9 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | GC Arm N-I Dose Level 2b | 7.7 | 95% Confidence Interval 2.1 to 18.5 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | PC Arm N | 0.0 | 95% Confidence Interval 0 to 18.5 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | PC Arm N-I Dose Level 1 | 0.0 | 95% Confidence Interval 0.0 to 70.8 | Percentage of Participants | |
| Objective Response Rate ( ORR ) | PC Arm N-I Dose Level 2 | 0.0 | 95% Confidence Interval 0.0 to 18.5 | Percentage of Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow184
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | TNBC Arm N | 18 | |
| Treatment Period | STARTED | TNBC Arm N-I Dose Level 1 | 3 | |
| Treatment Period | STARTED | TNBC Arm N-I Dose Level 2 | 18 | |
| Treatment Period | STARTED | GC Arm N | 59 | |
| Treatment Period | STARTED | GC Arm N-I Dose Level 1 | 3 | |
| Treatment Period | STARTED | GC Arm N-I Dose Level 2 | 49 | |
| Treatment Period | STARTED | GC Arm N-I Dose Level 2b | 52 | |
| Treatment Period | STARTED | PC Arm N | 18 | |
| Treatment Period | STARTED | PC Arm N-I Dose Level 1 | 3 | |
| Treatment Period | STARTED | PC Arm N-I Dose Level 2 | 18 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 participant flowAdverse events11,823
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 | TNBC Arm N | 1 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | TNBC Arm N-I Dose Level 1 | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | TNBC Arm N-I Dose Level 2 | 4 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | GC Arm N | 19 | 59 | |
| other | Anaemia | Blood and lymphatic system disorders | GC Arm N-I Dose Level 1 | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | GC Arm N-I Dose Level 2 | 12 | 49 | |
| other | Anaemia | Blood and lymphatic system disorders | GC Arm N-I Dose Level 2b | 17 | 52 | |
| other | Anaemia | Blood and lymphatic system disorders | PC Arm N | 5 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | PC Arm N-I Dose Level 1 | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PC Arm N-I Dose Level 2 | 8 | 18 |
1 to 10 of 11,823Source ClinicalTrials.gov
See all 11,823 adverse eventsAdverse event totals63
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TNBC Arm N | 17 | 18 |
| Total, all-cause mortality | TNBC Arm N-I Dose Level 1 | 3 | 3 |
| Total, all-cause mortality | TNBC Arm N-I Dose Level 2 | 18 | 18 |
| Total, all-cause mortality | GC Arm N | 53 | 59 |
| Total, all-cause mortality | GC Arm N-I Dose Level 1 | 3 | 3 |
| Total, all-cause mortality | GC Arm N-I Dose Level 2 | 42 | 49 |
| Total, all-cause mortality | GC Arm N-I Dose Level 2b | 50 | 52 |
| Total, all-cause mortality | PC Arm N | 18 | 18 |
| Total, all-cause mortality | PC Arm N-I Dose Level 1 | 3 | 3 |
| Total, all-cause mortality | PC Arm N-I Dose Level 2 | 18 | 18 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse event totalsPapers5
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/NCT01928394
GET https://conductscience.org/api/trials/v1/NCT01928394/results?page=2