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NCT01658878 · ClinicalTrials.gov registry record · Phase 1
An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 657
- Enrollment target
NCT01658878: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01658878 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 657 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (995% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01658878, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 657 participants
- Enrollment target
Study Summary
The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.
Primary Outcome
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Interventions
- DRUG Ipilimumab
- BIOLOGICAL Nivolumab
- DRUG Cabozantinib
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 657 participants |
| Start Date | 2012-10-30 |
| Est. Completion | 2024-11-12 |
| Phase | Phase 1 |
What the finished NCT01658878 record still lists
NCT01658878 is an interventional study that assigns participants to a tested intervention. The registered 657 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 (995% higher).
The record links to 0 conditions, and to 4 interventions - of which Ipilimumab is the first listed.
NCT01658878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01658878 about?
NCT01658878 is a clinical study titled "An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer". The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subje...
What is the current status of trial NCT01658878?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 657 participants. The study started on 2012-10-30. Estimated completion is 2024-11-12.
What interventions are being tested in trial NCT01658878?
The interventions under investigation include: Ipilimumab (DRUG), Nivolumab (BIOLOGICAL), Cabozantinib (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT01658878?
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 NCT01658878's enrollment target sits among peer trials
657 22nd of 2000 higher than 1,979 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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