Protocol Number:
NCT02448381
Study Name:
A Phase III Multicenter Randomized Placebo Controlled Study to Determine the Efficacy of Topical SGX301 and Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma
Age Group:
Adult
Background Information:
The study will to evaluate the efficacy and safety of SGX301 in an ointment at a concentration of 0.25%, applied twice weekly for six weeks, under occlusion for 16-24 hours followed by the administration of visible light up to a dose of 8 joules/cm2 twice weekly for each of three 6-week cycles. The initial cycle compared to a placebo ointment applied for the first treatment cycle. A minimum of 3 and a maximum of 5 lesions will be identified and indexed for treatment and evaluation. In order to ensure that the CAILS assessment is based on the same number of lesions for each patient, the investigator (prior to randomization) will select 3 of the lesions in each patient for primary evaluation in the first two cycles of treatment.
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Protocol Number:
NCT02751151
Study Name:
Photodynamic therapy for prevention of non-melanoma
Age Group:
Adult
Background Information:
The study will draw patients from the Transplant Dermatology specialty clinic, where the investigators see organ transplant recipients (OTR) for regular screening and serve as a regional referral center for this population. Enrollment will be limited to 20 patients. Inclusion criteria are organ transplant recipients status, active immunosuppression for at least 5 years, and history of at least one NMSC.
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Protocol Number:
16-2427
Study Name:
Pilot Study of Neoantigen Profiling in Patients with Melanoma Treated
with PD-1 Blockade
Age Group:
Adult
Background Information:
This research study is designed to better understand the molecular determinants of response to immunotherapies including pembrolizumab and nivolumab. We hope to learn the relevance of tumor neoantigens in the recognition of cancer cells by the immune system. The ultimate goal is to rank and filter these neoantigens and correlate with response to immunotherapies.
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Protocol Number:
NCT02811783
Study Name:
Elorac, Inc. / A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion, 0.5%, for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sézary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL)
Age Group:
Adult
Background Information:
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing.
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Protocol Number:
NCT03635983
Study Name:
BMS CA045-001: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma
Age Group:
Adult
Background Information:
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.
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Protocol Number:
NCT03553836
Study Name:
KEYNOTE 716: Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study
Age Group:
Adult
Background Information:
The purpose of this study is to: test the safety of the research study drug, Pembrolizumab (MK-3475), also known as KEYTRUDA® and see how well the study drug, pembrolizumab, works compared to placebo in keeping cancer from coming back or spreading.
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Protocol Number:
NCT03138889
Study Name:
Propel: A Phase 1B, open-label, multicenter study to investigate the safety and preliminary efficacy of NKTR-214 in combination with Anti-PD-1 (Pembrolizumab) or Anti-PD-L1 (Atezolizumab) in patients with locally advanced or metastatic solid tumors
Age Group:
Adult
Background Information:
The purpose of this study is to test the safety, tolerability, and effectiveness of NKTR-214 given in combination with KEYTRUDA®
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Protocol Number:
NCT03445533
Study Name:
A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Age Group:
Adult
Background Information:
Refractory melanoma is a type of cancer mainly found on the skin, which may not be responding to available treatments. Researchers have developed a drug called IMO-2125 (sometimes referred to as "study drug"), which may be used to treat refractory melanoma. This is an investigational study, which means the study drug is experimental and is not approved by the U.S. Food and Drug Administration (FDA). The study is being done to compare the effectiveness of the study drug given in combination with ipilimumab (Yervoy®) compared to ipilimumab given alone.
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Protocol Number:
NCT03820986
Study Name:
A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)
Age Group:
Adult
Background Information:
The purpose of this study is to:
See how well the combination of study drugs (lenvatinib and pembrolizumab) work together
Test the safety and how well your body handles the combination of the study drugs
Find out how lenvatinib is absorbed and broken down in your body when given with pembrolizumab
Test the combination of the study drugs and see if they help patients live longer
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Protocol Number:
NCT03776136
Study Name:
A Multicenter, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)
Age Group:
Adult
Background Information:
The purpose of this study is to:
Test the safety of the study drugs, lenvatinib and pembrolizumab, to see how well the combination of study drugs work together, see how your body handles the combination of the study drugs.
Find out how lenvatinib is absorbed and broken down in your body when given with pembrolizumab
Test the combination of the study drugs and see if they help patients live longer
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Protocol Number:
NCT03833167
Study Name:
A Phase 3, Randomized, Doubleblind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Age Group:
Adult
Background Information:
The purpose of this study is to test the safety of the study drug, pembrolizumab, and whether it keeps your type of cancer from coming back or spreading compared to placebo. The purpose of this study is also to see if giving pembrolizumab after surgery and radiation helps patients with your type of cancer live longer.
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Protocol Number:
NCT03599713
Study Name:
A Phase 2 Study of INCMGA-0012 in Participants with Metastatic Merkel Cell Carcinoma (PODIUM)
Age Group:
Adult
Background Information:
The purpose of this study is to test the safety and effectiveness of the study drug INCMGA00012 in participants with Metastatic Merkel Cell Carcinoma.
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Protocol Number:
NCT03787602
Study Name:
A Phase 2, Open-Label, Single-Arm Study of KRT-232 in Patients With p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy
Age Group:
Adult
Background Information:
For participants diagnosed with Merkel cell carcinoma (MCC) and prior treatment with anti-PD-1 or anti-PD-L1 was not or is no longer effective. This is the first study of KRT-232 in patients with MCC after prior treatment with anti-PD-1 or anti-PD-L1 and it will evaluate how well tolerated KRT-232 is when given to participants with MCC, and whether KRT-232 can improve MCC outcomes. KRT-232 (formerly called AMG 232) is an investigational drug in a tablet form that is taken by mouth. KRT-232 has been shown in the laboratory to inhibit the growth of some tumor cells.
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Protocol Number:
NCT02890368
Study Name:
A Phase 1 Dose Escalation Trial of Intratumoral Injections of TTI-621 in Subjects with Relapsed and Refractory Percutaneously Accessible Solid Tumors and Mycosis Fungoides
Age Group:
Adult
Background Information:
TTI-621 is a type of protein called a fusion protein which is similar to an antibody. It is designed to target and block a protein called CD47. CD47 is present on cancer cells and is used by cancer cells to hide from your body’s immune system. Blocking CD47 with TTI-621 may help your body’s immune system find and destroy the cancer cells. This study is also being done to understand how the body absorbs and processes different doses of TTI-621 by measuring the levels of the study drug in the blood at different times. This is called pharmacokinetics (PK) testing. This study is also being conducted to understand how TTI-621 affects the body, such as its effect on the immune system; and to understand the side effects and possible benefit when TTI-621 is given alone and also together with different FDA approved anti-cancer treatments.
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Protocol Number:
NCT0383610
Study Name:
CemiplimAb Survivorship Epidemiology (CASE)
Age Group:
Adult
Background Information:
This is a prospective survivorship study of adult patients with Cutaneous Squamous cell Carcinoma (CSCC) who receive treatment with commercially available cemiplimab. The objectives of the study are to identify potential determinants of disease progression, Quality of Life (QOL), and other health-related outcomes. The study also looks to assess patient experience, QOL and functional status, in a real-world setting for patients with CSCC. The information collected from the study will be used to better understand the long-term effectiveness and safety of cemiplimab-rwlc in patients. Cemiplimab-rwlc has been approved by the U.S. FDA for treatment of advanced cutaneous squamous cell carcinoma.
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Protocol Number:
NCT02465060
Study Name:
NCI MATCH Molecular Analysis for Therapy Choice
Age Group:
Adult
Background Information:
This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
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Protocol Number:
NCT02693535
Study Name:
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Age Group:
Adult
Background Information:
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the performance (both safety and efficacy) of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. The study provides approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies, catalogues the choice of genomic profiling test by clinical oncologists and aims to learn about the utility of registry data to develop hypotheses for additional clinical trials.
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