Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase I Study of a p53MVA Vaccine in Combination With Pembrolizumab
This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment, that have failed prior therapy, and that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving vaccine therapy together with pembrolizumab may be a better treatment in patients with solid tumors.
PRIMARY OBJECTIVES: I. To determine the safety and tolerability of combined p53MVA vaccine (modified vaccinia virus Ankara vaccine expressing p53) and pembrolizumab that are well-tolerated in patients with refractory, tumor protein 53 (p53) over expressing cancer. SECONDARY OBJECTIVES: I. To evaluate clinical response and anti-p53 T cell immune responses. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes followed by modified vaccinia virus Ankara vaccine expressing p53 subcutaneously (SC) at least 30 minutes later once in weeks 1, 4, and 7. Patients may receive additional doses of pembrolizumab in weeks 10, 13, 16, and 19, for a maximum of 7 doses if there are no signs of progressive disease. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04209491 -
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
|
||
Completed |
NCT03963206 -
Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)
|
Phase 4 | |
Completed |
NCT03268499 -
TACE Emulsion Versus Suspension
|
Phase 2 | |
Recruiting |
NCT05044676 -
Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
|
||
Recruiting |
NCT05263830 -
Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
|
||
Recruiting |
NCT05095519 -
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
|
Phase 2 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Completed |
NCT05068193 -
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03781934 -
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
|
Phase 1/Phase 2 | |
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT04401800 -
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
|
Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Active, not recruiting |
NCT04039607 -
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
|
Phase 3 | |
Terminated |
NCT03970616 -
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT03642561 -
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
|
Phase 2/Phase 3 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03222076 -
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
|
Phase 2 |