Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03439891 · ClinicalTrials.gov registry record · Phase 2
Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastatic Liver Cancer
A Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Robin Kate Kelley.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 2
- Study locations
NCT03439891: Completed Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Robin Kate Kelley.
NCT03439891 is a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8 that has completed, run by Robin Kate Kelley. The registered enrollment target is 16 participants, below the 59-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03439891, a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, has completed, sponsored by Robin Kate Kelley.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies the best dose and side effects of sorafenib tosylate and nivolumab in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sorafenib tosylate and nivolumab may work better in treating patients with liver cancer.
Primary Outcome
MTD is defined as the dose in which 1 or more dose limiting toxicities (DLT) is reported by study participants in Part 1 within the first cycle of treatment. Participants in Part 1 must receive at least 2 doses of nivolumab and at least 75% of sorafenib doses within 28 days (1 cycle), or experience a qualifying DLT event to be evaluable.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG Sorafenib
Study Locations (2)
California
- University of California, Davis - Sacramento
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-04-16 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 2 |
What the finished NCT03439891 record still lists
NCT03439891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 59-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (73% lower).
The record links to 7 conditions, with Stage III Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03439891 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03439891 about?
NCT03439891 is a clinical study titled "Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastatic Liver Cancer". This phase II trial studies the best dose and side effects of sorafenib tosylate and nivolumab in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Sorafeni...
What is the current status of trial NCT03439891?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2018-04-16. Estimated completion is 2023-11-30.
What conditions does trial NCT03439891 study?
This clinical trial studies the following conditions: Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC V8, Stage IVA Hepatocellular Carcinoma AJCC V8, Stage IVB Hepatocellular Carcinoma AJCC V8.
What interventions are being tested in trial NCT03439891?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT03439891?
This trial is sponsored by Robin Kate Kelley, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03439891 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Hepatocellular Carcinoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03439891's enrollment target sits among peer trials
16 13th of 14 higher than 2 of 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Hepatocellular Carcinoma AJCC v8 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
-
Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer
RECRUITING · Phase 2
-
Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma
RECRUITING · Phase 2
-
Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
RECRUITING · Phase 2
-
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
RECRUITING · Phase 2
-
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
ACTIVE NOT RECRUITING · Phase 2
-
Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI