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Clinical Trial News

Adjuvant Nivolumab Shows Significant Benefit in Resected Stage IIB/C Melanoma

A phase 3 trial demonstrates that adjuvant nivolumab significantly improves recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with resected stage IIB/C melanoma, compared to placebo. The study, involving 790 patients across 20 countries, highlights a 58% reduction in the risk of recurrence or death with nivolumab, alongside a manageable safety profile consistent with previous reports.

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

NCT04099251Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 10/28/2019

mRNA Cancer Vaccines: Recent Advances and Future Directions in Immunotherapy

  • mRNA vaccines have emerged as a promising platform for cancer immunotherapy due to their cost-effectiveness, safety, and rapid development potential.
  • Neoantigen identification is crucial for developing effective mRNA cancer vaccines, with recent studies focusing on proteogenomic approaches and tumor-associated antigens.
  • Adjuvants like CpG oligodeoxynucleotides and monophosphoryl lipid A can enhance mRNA vaccine efficacy by stimulating the immune system.
  • Clinical trials are exploring the potential of personalized mRNA vaccines to activate neoantigen-specific T cells and improve outcomes in various cancers.

Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors

NCT05949775Not Yet RecruitingNot Applicable
Stemirna Therapeutics
Posted 7/20/2023

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Cancer and Non-small Cell Lung Cancer

NCT03908671RecruitingNot Applicable
Stemirna Therapeutics
Posted 10/18/2019

Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC

NCT03164772CompletedPhase 1
Ludwig Institute for Cancer Research
Posted 12/20/2017

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms

NCT03468244Unknown StatusNot Applicable
Changhai Hospital
Posted 5/1/2018

A Study of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors

NCT05942378Not Yet RecruitingPhase 1
Fudan University
Posted 7/1/2023

Evaluate the Safety and Tolerability of JCXH-212 Monotherapy and Combined With Toripalimab in the Treatment of Malignant Solid Tumors

NCT05579275RecruitingEarly Phase 1
Peking University Cancer Hospital & Institute
Posted 2/6/2023

Clinical Study of mRNA Vaccine in Patients With Liver Cancer After Operation

NCT05761717Not Yet RecruitingNot Applicable
Shanghai Zhongshan Hospital
Posted 4/20/2023

Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer

NCT05916261RecruitingEarly Phase 1
Ruijin Hospital
Posted 4/26/2023

A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors

NCT05198752RecruitingPhase 1
Stemirna Therapeutics
Posted 3/18/2022

A Safety and Efficacy Study of XH001 Combined With Sintilimab Injection in Advanced Solid Tumors

NCT05940181RecruitingNot Applicable
jianming xu
Posted 3/1/2023

An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer

NCT02140138TerminatedPhase 2
CureVac
Posted 6/1/2014

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms

NCT06019702RecruitingPhase 1
Sir Run Run Shaw Hospital
Posted 9/8/2023

Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery

NCT04161755Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 12/13/2019

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

NCT03948763TerminatedPhase 1
Merck Sharp & Dohme LLC
Posted 6/26/2019

Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Gastric Cancer, Esophageal Cancer and Liver Cancer

NCT05192460RecruitingNot Applicable
jianming xu
Posted 3/28/2022

Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer

NCT05456165WithdrawnPhase 2
Gritstone bio, Inc.
Posted 5/19/2022

Application of mRNA Immunotherapy Technology in Epstein-Barr Virus-related Refractory Malignant Tumors

NCT05714748Active, Not RecruitingPhase 1
West China Hospital
Posted 2/8/2023

Safety and Tolerability of CVGBM in Adults with Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma

NCT05938387Active, Not RecruitingPhase 1
CureVac
Posted 6/1/2023

RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors

NCT05660408Active, Not RecruitingPhase 1
University of Florida
Posted 3/12/2025

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy

NCT05264974SuspendedPhase 1
University of Florida
Posted 8/1/2025

A Clinical Study of mRNA Vaccine (ABOR2014/IPM511) in Patients With Advanced Hepatocellular Carcinoma

NCT05981066RecruitingNot Applicable
Peking Union Medical College Hospital
Posted 7/10/2023

Application of mRNA Immunotherapy Technology in Hepatitis B Virus-related Refractory Hepatocellular Carcinoma

NCT05738447RecruitingPhase 1
West China Hospital
Posted 2/15/2023

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

NCT04382898TerminatedPhase 1
BioNTech SE
Posted 12/19/2019

Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer

NCT03480152TerminatedPhase 1
National Cancer Institute (NCI)
Posted 5/18/2018

Combination Therapy of Personalized mRNA-0217 Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors

NCT05916248RecruitingEarly Phase 1
Ruijin Hospital
Posted 12/20/2023

Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors

NCT05359354RecruitingNot Applicable
YueJuan Cheng
Posted 9/1/2022

Low Tidal Volume Ventilation Reduces Postoperative Pulmonary Complications: Meta-Analysis

  • A meta-analysis of 16 RCTs involving 4993 patients reveals that low tidal volume ventilation (6-8 ml/kg) during surgery reduces postoperative pulmonary complications compared to high tidal volume ventilation (>8 ml/kg).
  • Driving pressure-guided PEEP strategies also demonstrate a significant reduction in postoperative pulmonary complications compared to fixed PEEP.
  • Higher PEEP levels (≥6 cm H2O) are associated with an increased risk of intraoperative cardiovascular complications.
  • Ventilation strategies did not significantly impact 30-day mortality rates in the analyzed studies.

AI Algorithm Predicts Brain Cancer Outcomes, CAR-T Cell Therapy Shows Promise

  • Stanford Medicine scientists have developed an AI algorithm to predict outcomes for patients with complex brain tumors, potentially improving treatment strategies.
  • A clinical trial is underway, supported by a $12 million CIRM award, to assess the safety of CAR-T cell therapy in treating a deadly form of brain cancer.
  • The CAR-T cell therapy involves bioengineering a patient's own immune cells to target and destroy cancer cells, offering a personalized approach to treatment.
  • These advancements represent significant steps toward more effective and targeted therapies for challenging brain cancers, addressing a critical unmet need.

Capricor Therapeutics Gains FDA Alignment on HOPE-3 Trial Design for CAP-1002 in Duchenne Muscular Dystrophy

  • Capricor Therapeutics aligned with the FDA on key aspects of the HOPE-3 trial design for CAP-1002, a cell therapy for Duchenne muscular dystrophy (DMD).
  • The HOPE-3 trial is expected to enroll approximately 58 patients, with topline results anticipated in the final quarter of 2024 and a BLA submission in 2025.
  • The primary endpoint for HOPE-3 remains the mean change from baseline in the Performance of the Upper Limb (PUL version 2.0) at 12 months post-treatment.
  • Positive 24-month data from the HOPE-2 open-label extension study showed improvements in cardiac and skeletal function, underscoring CAP-1002's potential.

A Study of Deramiocel (CAP-1002) in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy

NCT05126758Active, Not RecruitingPhase 3
Capricor Inc.
Posted 6/22/2022

A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy

NCT03406780CompletedPhase 2
Capricor Inc.
Posted 4/4/2018

Determine the Safety and Dose of EN001 in Patients With Duchenne Muscular Dystrophy(DMD)

NCT05338099CompletedPhase 1
ENCell
Posted 1/18/2022

Open-label Extension of the HOPE-2 Trial

NCT04428476Active, Not RecruitingPhase 2
Capricor Inc.
Posted 8/5/2020

South Korea Positions Life Sciences Sector for Global Leadership with Strategic Five-Point Plan

• South Korea's government has unveiled an ambitious five-point strategy to revolutionize its bio-health industry, focusing on innovation in medical services, export growth, and AI-driven R&D advancement.
• The country's life sciences sector is experiencing rapid growth through substantial public-private investments, supported by advanced infrastructure and a highly skilled STEM workforce.
• Major players like Samsung Biologics, LG Chem, and Celltrion are driving industry growth, while government initiatives provide robust support for biotech startups and research development.

Crinecerfont Shows Promise in Treating Children with Congenital Adrenal Hyperplasia

Crinecerfont, an investigational oral treatment, has demonstrated effectiveness in controlling adrenal androgens in children and adolescents with classic congenital adrenal hyperplasia (CAH) in a phase 3 study. The treatment allows for a reduction in daily glucocorticoid doses while maintaining androgen control, marking a significant advancement in CAH management.

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

NCT04490915Active, Not RecruitingPhase 3
Neurocrine Biosciences
Posted 12/16/2020

Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

NCT04806451Active, Not RecruitingPhase 3
Neurocrine Biosciences
Posted 6/25/2021

Cuba Advances Phase III Clinical Trial of Jusvinza for Rheumatoid Arthritis Treatment

Drug Approval
  • Cuban scientists are conducting a Phase III clinical trial of Jusvinza, an immunomodulatory and anti-inflammatory drug, in rheumatoid arthritis patients across the country.
  • The drug received sanitary registration from Cuban regulatory authorities in September after demonstrating quality, safety, and efficacy in treating rheumatoid arthritis.
  • Patients in the trial have shown improved quality of life with no adverse effects reported in the first four doses of treatment.
  • Camagüey province leads enrollment with 212 volunteers, with participants receiving monthly doses for six months after completing the initial four-dose regimen.

Relyvrio Shows Extended Survival Benefit in ALS Patients: PRO-ACT Database Analysis

  • Post-hoc analysis using the PRO-ACT database suggests Relyvrio (sodium phenylbutyrate and taurursodiol) extends median overall survival by 10.39 months in ALS patients compared to treatment-naïve controls.
  • The study addresses limitations of the CENTAUR trial, where placebo-to-active crossover may have underestimated Relyvrio's survival benefit in intent-to-treat analysis.
  • Propensity score matching was employed to minimize bias between the Relyvrio-treated group from CENTAUR and the external control group from PRO-ACT.
  • Findings support the potential for a greater survival benefit with Relyvrio in ALS than previously observed, pending confirmation in ongoing Phase 3 trials.

AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT03127514CompletedPhase 2
Amylyx Pharmaceuticals Inc.
Posted 6/22/2017

Open Label Extension Study of AMX0035 in Patients With ALS

NCT03488524CompletedPhase 2
Amylyx Pharmaceuticals Inc.
Posted 3/29/2018

Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment

NCT05021536Active, Not RecruitingPhase 3
Amylyx Pharmaceuticals Inc.
Posted 10/28/2021

RG6501 Shows Rapid Improvement in Retinal Structure for Geographic Atrophy Patients

  • Phase 1/2a trial results for RG6501 (OpRegen) demonstrate significant improvements in outer retinal structure within three months of a single administration in patients with geographic atrophy secondary to AMD.
  • All five patients in cohort 4 with extensive coverage of GA lesions showed structural improvements and achieved an average 12.8 letter BCVA gain by one year compared to baseline.
  • The cell therapy, developed through a collaboration between Lineage Cell Therapeutics, Roche, and Genentech, works by delivering allogeneic retinal pigmented epithelial cells to support remaining retinal cells in atrophic areas.

Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration

NCT02286089Active, Not RecruitingPhase 1
Hoffmann-La Roche
Posted 4/1/2015

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