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 compared to surgery
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 51 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
RecruitingThe goal of this clinical trial is to learn if DOC1021 + pIFN will be safe and will lead to tumor responses in patients with refractory melanoma. DOC1021 is a dendritic cell immunotherapy derived from a patient's own blood cells and loaded with antigens from the patient's tumor in the form of tumor lysate and mRNA. The goal is to stimulate a T cell immune response that eliminates tumor cells. The study consists of two components: an initial phase I safety study to confirm safety/tolerability of the treatment regimen, and, subsequently, a single-arm phase II cohort to assess efficacy of the treatment regimen. All participants will: * Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection * Receive two doses of DOC1021 under image guidance 2 weeks apart * Receive subcutaneous pIFN injections weekly for a total of 4 doses in parallel with the DOC1021 injections * Undergo an optional image-guided perinodal DOC1021 booster injection approximately 6 months after the first DOC1021 dose along with additional subcutaneous pIFN injections at time of the booster and the subsequent week for a total of 2 pIFN doses * Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive optional treatment with anti-PD1 agents
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 5 more
SponsorDiakonos Oncology Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereOrange, California, United States + 20 more
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors
NCT07317505 ·
Cancer, Cancer (Solid Tumors)
RecruitingThe goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors. The main questions it aims to answer are: * To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used in the second part of the study (Phase 1a) * To assess effectiveness of JMT108 in participants with locally advanced or metastatic tumors (Phase 1b) * To evaluate how quickly JMT108 is metabolized by the body (pharmacokinetics or PK) * To evaluate if antibodies to the study drug develop (immunogenicity) * To evaluate preliminary efficacy to the drug * To explore the pharmacodynamic (PD) characteristics of JMT108 * To explore the correlation between biomarker levels and preliminary efficacy Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive JMT108 by intravenous injection every 2 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment * Be followed for progression every 3 months for up to 2 years
PhasePhase 1
TypeInterventional
Age18 Years
WhereHuntersville, North Carolina, United States + 2 more
SponsorConjupro Biotherapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
RecruitingThis study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors. The trial includes two groups: * Cohort 1: Patients with ER+ / HER2- breast cancer receiving fulvestrant and capivasertib * Cohort 2: Patients with unresectable or metastatic cutaneous melanoma receiving pembrolizumab The Phase 1b portion will find the recommended Phase 2 dose (RP2D). The Phase 2 portion will further evaluate clinical activity at the RP2D using response criteria for solid tumors (RECIST 1.1). The study will also evaluate pharmacokinetics, pharmacodynamics, disease control, and overall safety.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 16 more
SponsorAminex Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Identification of Metabolic Phenotypes Associated With Melanoma Metastasis
RecruitingThe goal of this study is to observe metabolic features associated with human melanoma tumors.
Phase—
TypeObservational
Age18 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾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
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 + 65 more
SponsorImmatics US, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
RecruitingA phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 15 more
SponsorOncoNano Medicine, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
NCT03452774 · Cancer, Metastatic,
Cancer, Cancer of Pancreas
RecruitingInternational registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention.
Phase—
TypeObservational
AgeAny
WhereBirmingham, Alabama, United States + 67 more
SponsorMassive Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
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 A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
NCT05914116 · Advanced Solid Tumors
RecruitingThis is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 106 more
SponsorDualityBio Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
NCT05059444 · Bladder Carcinoma, Ureter Carcinoma, Renal Pelvis Carcinoma
RecruitingThe purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 56 more
SponsorGuardant Health, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
NCT02332668 ·
Melanoma,
Lymphoma, Solid Tumor
RecruitingResearchers are looking for new ways to treat children with different types of melanoma (skin cancer), solid tumors, and lymphomas (blood cancers) that are any of these: * Advanced, which means cancer spread in the body or cannot be removed with surgery * Relapsed, which means cancer has come back after it had responded to previous treatment (responded means it stopped growing, gets smaller, or disappeared) * Refractory, which means cancer did not respond to previous treatment Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Researchers want to learn if different doses of pembrolizumab can cause at least 1 of the types of cancer to get smaller or go away. With Amendment 8, enrollment of participants with solid tumors and participants 6 months to under 12 years old with melanoma were closed. With Amendment 13, enrollment was closed for participants with relapsed refractory classical Hodgkin lymphoma (rrCHL), microsatellite instabilty-high (MSI-H) solid tumors, tumor-mutational burden-high (TMB-H) solid tumors, and participants 12 years old to \<18 years old with advanced melanoma.
PhasePhase 1 / Phase 2
TypeInterventional
Age6 Months – 17 Years
WhereAurora, Colorado, United States + 15 more
SponsorMerck Sharp & Dohme LLC
▾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
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 Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
NCT06326411 · Oncology, MEK Mutation, RAF Gene Mutation
RecruitingThis is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options.
PhasePhase 1
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 22 more
SponsorNested Therapeutics, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
NCT06090266 ·
Cancer, Tumor, Solid, Malignant Neoplasm
RecruitingThis is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR502 administered as a monotherapy and in combination with cemiplimab in subjects with advanced solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereAustin, Texas, United States + 3 more
SponsorOncoResponse, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
RecruitingTTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.
PhasePhase 1
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 40 more
SponsorTizona Therapeutics, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Dabrafenib and/or Trametinib Rollover Study
RecruitingThis study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
PhasePhase 4
TypeInterventional
Age18 Years – 100 Years
WhereScottsdale, Arizona, United States + 31 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
NCT04370587 · Solid Tumor,
Melanoma, HNSCC
RecruitingThis is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 8 more
SponsorImmVira Pharma Co. Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts