Stage IV Cutaneous Melanoma AJCC v6 and v7 Clinical Trial
Official title:
A Phase Ib/II Study of Propranolol With Fixed-Dose Pembrolizumab in Patients With Unresectable Stage III and Stage IV Melanoma
This phase Ib/II trial studies the side effects and best dose of propranolol hydrochloride when given together with pembrolizumab and how well they work in treating patients with stage IIIC-IV melanoma that cannot be removed by surgery. Pembrolizumab is a monoclonal antibody that "takes the brakes off the immune system" and thus allows for anti-tumor immune responses. Propranolol hydrochloride is a beta adrenergic blocking agent that can enhance immune cell responses when under stress. Giving propranolol hydrochloride and pembrolizumab may work better in treating patients with melanoma.
PRIMARY OBJECTIVES: I. To determine dose limiting toxicities (DLT) of propranolol hydrochloride (propranolol) in combination with fixed dose pembrolizumab in the treatment of melanoma. II. To evaluate the efficacy of pembrolizumab in combination with propranolol in patients with melanoma, as determined by overall response rate (ORR) per immune-modified Response Evaluation Criteria in Solid Tumors (RECIST) (1). SECONDARY OBJECTIVES: I. To evaluate the efficacy of pembrolizumab in combination with propranolol in patients with melanoma, as determined by secondary measures of efficacy, including: progression free survival (PFS) and overall survival (OS). TERTIARY OBJECTIVES: I. To correlate baseline or changes in the levels of biomarkers, like, peripheral T-cell subsets/myeloid derived suppressor cells (MDSC)/cytokines/urinary catecholamine and perceived stress scale (PSS) with efficacy (ORR, PFS, OS) in melanoma patients treated with pembrolizumab and propranolol. OUTLINE: This is a phase Ib, dose-escalation study of propranolol hydrochloride followed by a phase II study. Patients receive propranolol hydrochloride orally (PO) twice daily (BID) and pembrolizumab intravenously (IV) over 30 minutes of day 1. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3 months for 6 months, and then every 6 months thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02196181 -
Dabrafenib and Trametinib for the Treatment of Patients With Stage III-IV BRAF Mutant Melanoma That Cannot Be Removed by Surgery
|
Phase 2 | |
| Completed |
NCT02158520 -
Nab-Paclitaxel and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery
|
Phase 2 | |
| Active, not recruiting |
NCT01955460 -
Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma
|
Phase 1 | |
| Recruiting |
NCT02339571 -
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT01480154 -
Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03325101 -
Dendritic Cell Therapy After Cryosurgery in Combination With Pembrolizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Remove by Surgery
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02097225 -
Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
| Active, not recruiting |
NCT01364051 -
Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT01274338 -
Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
|
Phase 3 | |
| Completed |
NCT02304458 -
Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas
|
Phase 1/Phase 2 | |
| Terminated |
NCT03050060 -
Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02965716 -
Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
|
Phase 2 | |
| Active, not recruiting |
NCT01590069 -
Aerosolized Aldesleukin in Treating Patients With Lung Metastases
|
Phase 1 | |
| Terminated |
NCT03425461 -
Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma
|
Phase 1 | |
| Active, not recruiting |
NCT01638533 -
Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction
|
Phase 1 | |
| Active, not recruiting |
NCT01902173 -
Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT00937937 -
Dinaciclib in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
| Active, not recruiting |
NCT03021460 -
Pembrolizumab and Ibrutinib in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
|
Phase 1 | |
| Completed |
NCT01740557 -
Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01950390 -
Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
|
Phase 2 |