Svetomir N. Markovic, M.D., Ph.D.

The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.

The current feasibility study has two aims: (1) optimize the patient (Aim 1a) and nurse (Aim 1b) experience of the VIGILANT app workflow; and (2) gather prliminary data on the number of patients who develop Grade 3 + 4 irAE or require ER visit within 100 days of registration and treatment with IPI/NIVO.  This effort will allow us to refine VIGILANT as we advance its development into a clinically useful device for remote patient monitoring and gather preliminary evidence on the potential clinical benefit of its use.

The purpose of this study is to monitor T cell responses from patients with advanced cancer who are being treated with an anti-PD (programmed death)-1 monoclonal antibody, and compare them with clinical outcomes.

This phase I trial is looking to see if sargramostim given with a nebulizer, in combination with standard immune checkpoint inhibitor therapy with nivolumab can help control melanoma that has metastasized to the lungs.

The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.

The main purpose of this study is to compare the effectiveness of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms 1. LGX818 450mg QD plus MEK162 45mg BID (denoted as Combo 450 arm) 2. LGX818 300mg QD monotherapy (denoted as LGX818 arm) or 3. vemurafenib 960mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:1. LGX818 300mg QD plus MEK162 45mg BID (denoted as Combo 300 arm) or 2. LGX818 300mg QD monotherapy (denoted as LGX818 arm).

This study will examine the safety profile of SEA-CD40 given alone and in combination with pembrolizumab. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

The purpose of this study is to demonstrate pharmacokinetic non-inferiority for nivolumab + relatlimab FDC SC (fixed-dose combination for subcutaneous administration) formulation versus nivolumab + relatlimab FDC IV formulation.

The purpose of this study is to determine whether Nivolumab in combination with Relatlimab is more effective than Nivolumab by itself in treating unresectable Melanoma or Melanoma that has spread

The purpose of this study is to obtain placenta for the purpose of developing assays to isolate and culture trophoblasts as a cell free fetal DNA (cffDNA) source.

The purpose of this study is to evaluate the immune regulation at the point where maternal genes meet fetal genes in the tissues of the placenta. Specimens from the placentas of healthy pregnancies will be collected, and genetic arrays from both areas, maternal and fetal, will be prepared and compared.

The purpose of this study is to determine how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

The purpose of this study is to evaluate the performance of the wearable tPatch device when compared to an oral temperature measuring device in patients who have undergone a post-autologous bone marrow transplant.

Our group has explored the use of genomic RNA/phage display libraries derived from primary human malignant melanoma cells as a means of identifying antibody detectable targets on cancer cells (cancer vaccines or antibody guided therapeutics).  In this approach, we isolate and affinity-column immobilize the IgG fraction from patient serum before and after immune therapy for melanoma, and expose the immobilized antibodies to bacteriophage expressing approximately 2x109 overlapping cDNA sequences of paired (same patient derived plasma and cancer cells) melanoma genomic RNA.  Phage, expressing melanoma cDNA express the proteins/peptides on their capsid are “recognized” by the immobilized antibodies are retained in the column, and subsequently eluted for DNA sequencing.  Comparison of the DNA profiles of the eluted phage using pre-immunotherapy and post-immunotherapy patient sera will reveal emergence of new antibodies (post-immunotherapy gain of antibodies) against proteins of potential interest for melanoma targeting.  In the current proposal, we hypothesize that reacting COVID serum from patients that have recovered from COVID infection and compare to non-infected self-serum (if available) and control healthy volunteer serum (available in our lab) may identify protein targets that have developed as a result of the COVID infection and could be useful in the development of a COVID vaccine as well as a serologic test for anti-COVID immunity. 

This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TMZ at different times, which are determined individually for each patient based on the phase (biorhythm) of the immune system response against the tumor may allow for a better drug response and may kill more tumor cells.

This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab therapy. New diagnostic procedures, such as single-photon emission computed tomography (SPECT/CT), may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, may carry radiation directly to cancer cells and not harm normal cells. Giving 99mTc-HYNIC-IL2 with SPECT/CT may help find tumor growth in patients with stage IV melanoma

The purpose of this study is to learn about the ability of fetal DNA to activate the immune system.

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.

The purpose of this study is to determine the overall rate of response of brain metastases in subjects with central nervous system (CNS) metastases due to metastatic melanoma with a BRAF V600 mutation who have relapsed or progressed from initial or systemic disease.

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RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

This randomized phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab or ipilimumab works as first-line therapy in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab is more effective than ipilimumab in treating melanoma.

The purpose of this study is to gain stepwise understanding of the fundamental biology governing human antitumor immunity, by systematic study of the tumor-immune interface at the level of the TME, taking advantage of the heterogeneity of different interacting tumor and immune cell subsets.

This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Molecularly targeted therapy works by treating patients with substances that kill cancer cells by targeting key molecules involved in cancer cell growth.