A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
Melanoma (Excluding Uveal Melanoma)Cervical Carcinoma16 moreThis is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head...
Metastatic Solid TumorsNon-small Cell Lung Cancer7 moreThis is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through 4-1BB agonism.
Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma...
MelanomaThis research study is studying a new type of personalized neoantigen vaccine (NeoVax) plus Montanide® in combination with Ipilimumab (Yervoy™) and Nivolumab (Opdivo®) as a possible treatment for melanoma. The drugs involved in this study are: Personalized Neoantigen Vaccine Poly-ICLC (Hiltonol®) Montanide® Ipilimumab (Yervoy™) Nivolumab (Opdivo®)
Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients
MelanomaThe main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma...
MelanomaLymphoma3 moreThis is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer: advanced melanoma (6 months to <18 years of age), advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age), relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age), or advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age), or with adjuvant treatment of resected high-risk Stage IIB, IIC, III, or IV melanoma in children 12 years to <18 years of age Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts. With Amendment 8, enrollment of participants with solid tumors and of participants aged 6 months to <12 years with melanoma were closed. Enrollment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H solid tumors also continues.
A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib
MelanomaThis study evaluates whether it is safe to administer a helper peptide vaccine with BRAF inhibitor and MEK inhibitor therapy. This study will also evaluate the effects of the combination of the peptide vaccine and BRAF inhibitors/MEK inhibitors on the immune system. We will monitor these effects by performing tests in the laboratory on participants' blood and tumor samples.
Duration of Anti-PD-1 Therapy in Metastatic Melanoma
Unresectable/Metastatic MelanomaThe purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.
Dabrafenib and/or Trametinib Rollover Study
MelanomaNon Small Cell Lung Cancer3 moreThis study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
Study of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint...
Stage III MelanomaStage IV MelanomaThis is a study of transfusion of TBX-3400 in patients with stage III and IV melanoma resistant or refractory to Immune Checkpoint Inhibitors. The patient's own blood cells are exposed to a protein that has been shown in the laboratory to result in anti-tumor activity. The study hypothesis is that TBX-3400 cells will enhance anti-tumor activity and improve the body's immune response.
Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
Uveal MelanomaThe purpose of this study is to assess the safety and efficacy of hypofractionated stereotactic LINAC radiotherapy with 10 fractions at 6 Gy per fraction at the 80% isodose for the planning target volume (PTV) in patients with uveal melanoma. Patients will be followed-up for 10 years after radiotherapy regarding local tumor control, visual acuity, secondary complications and survival.