Unresectable Melanoma Clinical Trial
Official title:
A Randomized Phase II Trial of Ipilimumab With or Without Bevacizumab in Patients With Unresectable Stage III or Stage IV Melanoma
This randomized phase II trial studies how well ipilimumab with or without bevacizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES: I. To compare overall survival for patients receiving ipilimumab plus bevacizumab versus ipilimumab alone. SECONDARY OBJECTIVES: I. To evaluate the progression free survival, response rate and safety in patients receiving ipilimumab plus bevacizumab versus ipilimumab alone. II. To evaluate the utility of immune related response criteria (irRC) in patients receiving ipilimumab plus bevacizumab versus ipilimumab alone. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: INDUCTION THERAPY: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning cycle 8, patients receive ipilimumab IV over 90 minutes on day 1. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. ARM B: INDUCTION THERAPY: Patients receive ipilimumab IV over 90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive bevacizumab as in Induction Therapy. Beginning cycle 8, patients also receive ipilimumab IV over 90 minutes on day 1. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02224781 -
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
|
Phase 3 | |
Active, not recruiting |
NCT05103891 -
Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations
|
Phase 1 | |
Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
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 | |
Active, not recruiting |
NCT04967196 -
Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma
|
Phase 1 | |
Active, not recruiting |
NCT03033576 -
Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma
|
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 |
NCT03816332 -
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
|
Phase 1 | |
Recruiting |
NCT05628883 -
Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma
|
Phase 1 | |
Recruiting |
NCT04521075 -
A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05764395 -
Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors
|
Phase 2 | |
Completed |
NCT02115243 -
Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma
|
Phase 1 | |
Active, not recruiting |
NCT04526899 -
Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT05155254 -
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
|
Phase 3 | |
Recruiting |
NCT05269381 -
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05727904 -
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
|
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 | |
Active, not recruiting |
NCT01989585 -
Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma
|
Phase 1/Phase 2 | |
Completed |
NCT04698187 -
CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT03719131 -
Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy
|
Phase 2 |