Brief Summary
The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.
Protocol Interventions
Biological: Ipilimumab, Biological: Nivolumab
Brief Summary
This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.
Protocol Interventions
Drug: AU-007, Drug: Aldesleukin, Drug: Nivolumab
Brief Summary
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
Protocol Interventions
Drug: EIK1001, Drug: Pembrolizumab (KEYTRUDA® )
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care [SoC], best supportive care [BSC] on protocol survivor follow up) in patients with advanced non-ocular melanoma.
Protocol Interventions
Drug: Investigators Choice
Brief Summary
This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called study drugs. The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs.
* How much study drug is in the blood at different times.
* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
Protocol Interventions
Drug: relatlimab+nivolumab
Brief Summary
This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.
Protocol Interventions
Biological: Cytokine-induced memory-like natural killer cells, Biological: Relatilmab, Biological: Nivolumab
Brief Summary
This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator’s choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).
Protocol Interventions
Drug: Pembrolizumab, Drug: Ipilimumab, Drug: Nivolumab, Drug: Dacarbazine
Brief Summary
In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects with unresectable and metastatic melanoma.
Protocol Interventions
Drug: [203Pb]VMT01, Drug: [212Pb]VMT01, Drug: Nivolumab
Brief Summary
This is an open-label, single center, one cohort, non-randomized, phase II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with historical radiation therapy-alone control data.
Protocol Interventions
Drug: Pembrolizumab, Radiation: Hypofractionated radiation therapy
