Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases
MelanomaIn-Transit Metastasis of Cutaneous MelanomaThere is currently an urgent need for low cost and well tolerated intralesional agents for the management of in transit and cutaneous melanoma metastases that are unsuitable for, or resistant to, other therapies. This pilot study will determine whether intralesional injections of the sclerosant polidocanol into intransit and cutaneous melanoma lesions shows promise for efficacy, safety and ease of use that will enable this inexpensive and widely available agent to undergo further evaluation.
Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised...
Melanoma (Skin)The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma.
Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer
CarcinomaRenal Cell1 moreThis study will evaluate the safety and disease control rate of the combination of pembrolizumab plus low-dose interleukin-2 in patients who have either advanced melanoma or renal cell cancer.
Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible...
MelanomaThis study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.
Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab...
MelanomaThe purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.
Surgery of Melanoma Metastases After Systemic Therapy
MelanomaMelanoma Stage IV2 moreTo evaluate if surgical removal of residual disease adds benefit in stage IV melanoma patients with partial response or stable disease after a minimum 9 months of first-line PD-1 inhibition. Primary endpoint: Disease-free survival (DFS) at 12 months.
CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI)
Metastatic MelanomaThis is a phase Ib/II clinical trial to test safety and efficacy of combining CD24Fc with ipilimumab and nivolumab to decrease irAE, with built-in interim analyses, and safety and response stopping rules.
Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients...
Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v846 moreThis early phase I trial studies how well a genetic test called pharmacogenomics works in directing the optimal use of supportive care medications in patients with stage III-IV cancer. Pharmacogenomics is the study of how genes may affect the body's response to and interaction with some prescription medications. Genes, which are inherited from parents, carry information that determines things such as eye color and blood type. Genes can also influence how patients process and respond to medications. Depending on the genetic makeup, some medications may work faster or slower or produce more or fewer side effects. Pharmacogenomics testing may help doctors learn more about how patients break down and process specific medications based on their genes and improve the quality of life of cancer patients receiving clinical care.
PVSRIPO in Combination With Nivolumab in Melanoma
MelanomaIn this study, patients with metastatic melanoma who have at least one injectable lesion that has been refractory to PD-1 therapy (n=30 patients) will be enrolled. Cohort 1 will include 15 patients who progressed within 3 months (primary resistance) of starting PD-1 therapy and cohort 2 will be patients who progressed after at least 3 months of PD-1 therapy. Patients will receive up to 7 injections of PVSRIPO intra-lesionally in combination with Nivolumab. Nivolumab will be administered according to the FDA-approved dosing schedule of 480 mg intravenously every 4 weeks, beginning ~10 days after the first PVSRIPO infusion and will continue for 4 cycles. Nivolumab may be continued up to 2 years per standard of care after the completion of the PVSRIPO injections.
A CD8 Positron Emission Tomography With Computed Tomography (PET/CT) Study Using ⁸⁹Zr Df-IAB22M2C...
Metastatic MelanomaThe main purpose of this study is to investigate the utility of the new investigational imaging agent ⁸⁹Zr Df-IAB22M2C (CD8 PET/CT tracer) to monitor CD8 T-cell expansion and trafficking within tumors and associated tissues in patients with metastatic melanoma undergoing treatment with bempegaldesleukin and nivolumab as a single agent and in combination.