

A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis
Physician
Gary Lu, MD, PhD
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Treatment Agent: Binimetinib, Encorafenib
Synopsis: The purpose of this research study is to determine if high‑dose versus standard-dose regimens of encorafenib and binimetinib are safe and have positive effects in people who have melanoma brain metastasis and also have been found by their doctor to have a mutated gene called BRAFV600.
If you decide to take part in the study, you will have tests, exams and procedures that are part of your standard care and for study purposes such as a tumor sample, urine and blood samples for laboratory tests, Hepatitis B (HBV), Hepatitis C (HCV, and Human Immunodeficiency Virus (HIV) serology testing, dermatologic examination, ophthalmic examination, Echocardiogram (ECHO) or Multiple Gated Acquisition (MUGA) scans, MRI and CT scans, lesion assessment, serum pregnancy rest, and a physical exam to determine whether you are eligible for this study (screening procedures). Additional detailed information regarding these screening procedures is outlined within this document and will be further explained by the research team.
Your involvement in the study will last about 2 years.
If you choose to take part in this study, and if you meet eligibility criteria, you will be asked to make up to 51 visits to the study site over the next 24 months. In the first cycle (Days 1 and 15 of Cycle 1), each visit will take approximately 7 hours due to the multiple blood draws needed. The remaining visits will each take approximately 30 or 60 minutes.
Following the end of the study or after you have withdrawn from the study before its conclusion, your study doctor (or appointed delegate) may seek to establish your long‑term health status every 12 weeks approximately.
During your treatment, you will have tests, exams and procedures that are part of your standard care and for study purposes such as blood samples for biomarker testing, dermatologic examinations, am Echocardiogram (ECHO) or Multiple Gated Acquisition (MUGA) scan, MRI and CT scans, a urine pregnancy test, and physical exams. Additional detailed information regarding these procedures is outlined within this document and will be further explained by the research team.
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A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma
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Treatment Agent: Nivolumab, NKTR-214
Synopsis: The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214 , when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread. NKTR-214 and nivolumab in this informed consent may also be referred to as study medication(s) or treatment.
The study has other objectives as well. Blood and tissue samples will be obtained for research purposes. This is to explore how the study drugs behave in your body and the possible association between proteins and genetic markers in your blood or tumor tissue and how well the study drugs work. In the future, this might help to determine which people respond best to these study drugs. For this reason the results of these tests will not be sent to you or your doctor, will not be used in planning your care, and will not become part of your medical record.
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A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant Melanoma
Physician
Gary Lu, MD, PhD
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Treatment Agent: Ipilumumab and Nivolumab
Synopsis: This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
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STEP 1
STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE)
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An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage IIIB/C Melanoma Patients
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Treatment Agent: L19IL2 and L19TNF
Synopsis: Efficacy of Daromun neoadjuvant treatment followed by surgery to improve in a statistically significant manner the recurrence-free survival (RES) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery alone).
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A Phase 1b/2 Study of PV-10 Intralesional Injection in Combination with Immune Checkpoint Inhibition for Treatment of Metastatic Melanoma
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Treatment Agent: PV-10
Synopsis: Researchers want to find out if an investigational drug called PV-10 given in combination with another drug called pembrolizumab (also called Keytruda®) can help people with metastatic melanoma. PV-10 consists of a red dye (stain with the color red) called rose bengal that is dissolved in a sterile salt solution. Previous laboratory studies have shown that PV-10 gets into tumor cells without getting into normal cells and causes tumor cells to die. In earlier studies of people with melanoma, some melanoma tumors that were injected with PV-10 got smaller or went away. PV-10 has been tested in approximately 200 people with melanoma.
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CemiplimAb Survivorship Epidemiology (CASE) Study
Physician
Gary Lu, MD, PhD
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Treatment Agent: N/A
Synopsis: The purpose of the study is to determine the long-term effectiveness and safety of cemiplimab-rwlc in patients diagnosed with Cutaneous Squamous Cell Carcinoma (CSCC, a type of skin cancer) in the real world setting.
You are being asked to participate in this research study because you are receiving treatment with cemiplimab-rwlc for Cutaneous Squamous Cell Carcinoma (CSCC, a type of skin cancer) or initiating treatment with cemiplimab-rwlc for CSCC.
The study will last up to 3 years after enrollment. You are encouraged to remain in the study regardless of any changes in your treatment for CSCC, so that we can collect information about your treatment and outcomes.
The goal of the study is simply to observe your clinical care. After you have consented to take part in the study, we will collect past and current medical information that your doctor recorded in your medical records. The personal information that will be collected from your doctor’s files includes: your demographics, disease stage, risk factors, baseline health status, doctor’s notes including laboratory tests, surgery for CSCC.
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A Phase I, Open-Label, Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in First-Line Malignant Melanoma Patients Planned for Treatment with Pembrolizumab
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Treatment Agent: UV1
Synopsis: You are being asked to take part in this study because you have advanced melanoma and you are planned for treatment with pembrolizumab.
This is a clinical study involving an investigational drug, UV1. An investigational drug is a drug which has not yet been approved by the U.S. Food and Drug Administration (FDA).
The purpose of this study is to investigate the safety and tolerability of administering UV1 when given in combination with pembrolizumab, an FDA-approved cancer drug (immunotherapy) for melanoma. This is the first study of this drug combination.
UV1 has previously been tested in humans in clinical studies for prostate and non-small cell lung cancers. UV1 has also been investigated in combination with ipilimumab in a clinical study for melanoma patients.
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