Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
NCT03646617 · Metastatic Melanoma
RecruitingThe main purpose of this study is to determine the safety of combining ipilimumab and nivolumab with hypofractionated radiotherapy to a single tumor in patients with metastatic melanoma. Another purpose of this study is to determine the effect of ipilimumab, nivolumab and hypofractionated radiotherapy on the cancer as compared to ipilimumab and nivolumab.
PhasePhase 2
TypeInterventional
Age18 Years
WhereLancaster, Pennsylvania, United States + 2 more
SponsorAbramson Cancer Center at Penn Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
NCT06007690 · Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma
RecruitingThe primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 70 more
SponsorAura Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
NCT06585410 · Cutaneous Squamous Cell Carcinoma (CSCC)
RecruitingThis study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells. The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion. The study is looking at: * The side effects cemiplimab might cause * How well cemiplimab works
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 48 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
NCT05111574 · Anal Melanoma, Bladder Melanoma, Cervical Melanoma
RecruitingThis phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.
PhasePhase 2
TypeInterventional
Age18 Years
WhereAuburn, California, United States + 146 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
NCT03947385 · Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer
RecruitingThis is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study. Crizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity. As of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 14 more
SponsorIDEAYA Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
NCT03860883 · Cutaneous Melanoma, Stage II
RecruitingPatients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.
PhaseNA
TypeInterventional
Age18 Years
WhereMobile, Alabama, United States + 191 more
SponsorMelanoma and Skin Cancer Trials Limited
▾Tap for detailsClick for full details — eligibility, all locations, contacts IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
NCT06112314 · Advanced Melanoma
RecruitingThis is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
PhasePhase 3
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 210 more
SponsorImmunocore Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts Tebentafusp-tebn With LDT in Metastatic UM
NCT06626516 · Metastatic Uveal Melanoma
RecruitingThis study is a multicenter, open label phase I/ II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A\*0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, the Prinicipal Investigator will investigate the safety and efficacy of tebentafusp-tebn in combination with hepatic IE in patients with a low to moderate hepatic disease burden. In Part 2, the study will investigate the efficacy of tebentafusp-tebn in combination with TACE in patients with bulky hepatic disease.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorThomas Jefferson University
▾Tap for detailsClick for full details — eligibility, all locations, contacts SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
NCT06743126 · Melanoma, Cutaneous Malignant
RecruitingThis clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma. For patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 57 more
SponsorImmatics US, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
NCT06581406 · Metastatic Uveal Melanoma
RecruitingThe purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.
PhasePhase 2 / Phase 3
TypeInterventional
AgeAny
WhereScottsdale, Arizona, United States + 32 more
SponsorReplimune, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
NCT03941379 · Choroidal Melanoma, Indeterminate Lesions of Eye
RecruitingThe purpose of this observational research study is to follow participants who have been treated with either bel-sar or received alternate treatment (sham, standard of care therapy, etc.) while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. This study will collect information from procedures conducted as part of routine follow-up eye care and cancer care. Additionally, the registry will collect all adverse events, information about pregnancy and symptomatic overdose.
Phase—
TypeObservational
Age18 Years
WhereTucson, Arizona, United States + 15 more
SponsorAura Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
NCT06246916 · Melanoma
RecruitingThis study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
PhasePhase 3
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 107 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
NCT03567889 · Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID
RecruitingThe trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 36 more
SponsorPhilogen S.p.A.
▾Tap for detailsClick for full details — eligibility, all locations, contacts BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
NCT04752826 · Advanced Malignancies, Ovarian Cancer, T-cell Lymphoma
RecruitingThe goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy. The main questions it aims to answer are: * how safe and tolerable is BI-1808 * what is maximum tolerated or administrated dose * to determine recommended dose for further clinical trials. Participants will receive infusions of BI-1808 alone or combination with pembrolizumab every 3 weeks. For the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors and subjects with T-cell lymphoma (TCL),
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 24 more
SponsorBioInvent International AB
▾Tap for detailsClick for full details — eligibility, all locations, contacts Neoadjuvant Darovasertib in Primary Uveal Melanoma
NCT07015190 · Uveal Melanoma
RecruitingThis is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
PhasePhase 3
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 86 more
SponsorIDEAYA Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
NCT05498792 · Locally Advanced or Metastatic Melanoma
RecruitingPhase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.
PhaseEARLY_Phase 1
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorFox Chase Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
NCT06624644 · Melanoma (Skin Cancer), Melanoma Stage IIIB-IV, Cutaneous Melanoma
RecruitingThe goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor. 135 patients will be randomly (like flipping a coin) placed in 3 treatment groups. In the first group (LNS8801 only) - Patients will take 125mg tablet of LNS8801 by mouth once per day every day for up to 2 years. In the second group (LNS8801 + pembrolizumab) - Patients will take 125mg tablet of LNS8801 by mouth once per day plus 200 mg of pembrolizumab by IV infusion once every 3 weeks for up to 2 years. In the third group, called Physician's Choice (PC), patients will receive chemotherapy (dacarbazine or temozolomide) or immunotherapy (pembrolizumab, nivolumab/relatlimab or nivolumab/ipilimumab) as determined by their treating physician. How often the patient visits the clinic visits will depend on the treatment group. Besides returning to the clinic for treatment, the patient will undergo periodic safety assessments and other required study procedures such as imaging assessments.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereNewport Beach, California, United States + 6 more
SponsorLinnaeus Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Excision of Lymph Node Trial (EXCILYNT) (Mel69)
NCT05839912 · Melanoma
RecruitingThe purpose of this study is to find out if removing only the cancerous lymph node (known as a lymph node excision) is effective at preventing cancer from coming back in the same area of the lymph node excision. The study team is also trying to find out the side effects of this type of surgery and how much the surgery impacts quality of life. In order to be eligible for this study, participants must have been diagnosed with metastatic melanoma and have one detected cancerous lymph node by imaging (CT/PET scan) or clinical examination, and are a candidate for lymph node excision.
PhaseNA
TypeInterventional
Age18 Years
WhereAtlanta, Georgia, United States + 6 more
SponsorCraig L Slingluff, Jr
▾Tap for detailsClick for full details — eligibility, all locations, contacts Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
NCT05108298 · Breast Cancer, NOS, CNS Primary Tumor, NOS, Cervical Cancer, NOS
RecruitingThe purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
PhaseNA
TypeInterventional
Age18 Years – 39 Years
WhereFairbanks, Alaska, United States + 346 more
SponsorEastern Cooperative Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
NCT06500455 · Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Digestive System Carcinoma
RecruitingThis phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
PhasePhase 3
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 262 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts