Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Trial
Official title:
A Phase 2 Study of Combination Treatment of Binimetinib and Nivolumab for Advanced V600BRAF Wildtype Melanoma With Innate Anti-PD-1 Resistance
This phase II trial studies how well binimetinib and nivolumab work in treating patients with BRAF V600 wildtype melanoma that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced unresectable) or has spread to other places in the body (metastatic). Binimetinib may stop the growth of tumor 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 binimetinib and nivolumab together may work better in treating patients with melanoma compared to nivolumab alone.
PRIMARY OBJECTIVE: I. Objective response rate (ORR), which is defined as the proportion of response-evaluable participants either with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the investigator assessment, at best overall response. SECONDARY OBJECTIVE: I. Progression-free survival (PFS), clinical benefit rate (CR + PR + stable disease [SD] among response-evaluable participants, per RECIST 1.1), overall survival (OS) and duration of response (DOR). EXPLORATORY OBJECTIVE: I. Evaluation of histologic evidence of response (p-ERK reduction in residual tumor cells and CD8 T cell or tumor infiltrating lymphocytes or tumor infiltrating lymphocyte [TIL] infiltration induced by combination treatment) using pretreatment and early on-treatment tumor biopsies. OUTLINE: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and nivolumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 1 year, then annually thereafter. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039801 -
IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
|
Phase 1 | |
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 | |
Recruiting |
NCT05388877 -
E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma
|
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 |
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 | |
Recruiting |
NCT04697576 -
Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
|
Phase 1 | |
Recruiting |
NCT05341349 -
Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-100M for the Treatment of Melanoma Brain Metastases
|
Phase 1 | |
Active, not recruiting |
NCT03816332 -
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
|
Phase 1 | |
Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
Recruiting |
NCT04314401 -
National Cancer Institute "Cancer Moonshot Biobank"
|
||
Active, not recruiting |
NCT02506153 -
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
|
Phase 3 | |
Recruiting |
NCT05764395 -
Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors
|
Phase 2 | |
Not yet recruiting |
NCT06391099 -
Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer
|
N/A | |
Active, not recruiting |
NCT03025256 -
Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease
|
Phase 1 | |
Active, not recruiting |
NCT04516122 -
Bone Loss in Melanoma Survivors Receiving Immunotherapy
|
||
Recruiting |
NCT05269381 -
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
|
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 | |
Recruiting |
NCT06265285 -
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
|
Phase 2 | |
Recruiting |
NCT05098210 -
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor Positive Her2 Negative Metastatic Refractory Breast Cancer
|
Phase 1 |