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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 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 657 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01658878
The ClinicalTrials.gov registry entry for NCT01658878 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 657 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ipilimumab is the first listed.
NCT01658878 reports 0 study locations.
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.
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