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Whole-Pelvis Radiation Improves Survival in Muscle-Invasive Bladder Cancer

  • A retrospective study of 809 patients with muscle-invasive bladder cancer found that whole-pelvis radiation therapy improved cancer-specific and overall survival.
  • Patients receiving whole-pelvis radiation were more likely to have node-positive disease and receive neoadjuvant or concurrent chemotherapy.
  • Multivariable analysis showed whole-pelvis radiation therapy was associated with improved cancer-specific survival (HR 0.66, p = 0.016) and overall survival (HR 0.68, p = 0.002).
  • The findings suggest pelvic lymph node irradiation may improve survival, but prospective validation is needed to confirm these results.

Phase 3 Gliofocus Trial Aims to Improve Outcomes in MGMT Unmethylated Glioblastoma with Niraparib

  • The phase 3 Gliofocus trial (NCT06388733) is evaluating niraparib versus temozolomide in newly diagnosed MGMT unmethylated glioblastoma patients.
  • Preliminary data from a phase 0/2 trial showed a median overall survival of 20.3 months with niraparib plus radiotherapy, with favorable drug concentrations in brain tissue.
  • The Gliofocus trial aims to establish a clinically relevant overall survival benchmark of 18 months, improving both survival and quality of life for patients.
  • Researchers at the Ivy Brain Tumor Center are expediting clinical trial processes to bring new treatments to glioblastoma patients more efficiently.

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

NCT06388733RecruitingPhase 3
Ivy Brain Tumor Center
Posted 6/19/2024

Trial of Niraparib in Participants with Newly-diagnosed Glioblastoma and Recurrent Glioma

NCT05076513Active, Not RecruitingEarly Phase 1
Nader Sanai
Posted 10/29/2021

GPRC5D-Targeted Therapy Shows Promise in Multiple Myeloma Treatment

  • GPRC5D has emerged as a crucial target in multiple myeloma, offering new therapeutic avenues, especially before or as a bridge to BCMA-targeted therapies.
  • Talquetamab, a GPRC5D-directed therapy, has demonstrated efficacy in clinical trials like MonumenTAL-1 and MonumenTAL-3, showing potential in combination therapies.
  • Common toxicities associated with talquetamab, such as oral and skin-related issues, are generally manageable through dose adjustments and are less severe than those of bispecific antibodies.
  • GPRC5D-targeted treatments exhibit a reduced risk of infectious toxicity and have not been linked to significant cardiac, pulmonary, renal, or neuropathy-related adverse effects.

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

NCT05455320RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2022

A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma

NCT04674813Active, Not RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 2/24/2021

MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma

NCT04555551Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 9/8/2020

A Study of CAR-T Cells Targeting GPRC5D in the Treatment of r/r Multiple Myeloma

NCT05016778Active, Not RecruitingEarly Phase 1
Zhejiang University
Posted 6/8/2021

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/1/2021

A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)

NCT04557150Active, Not RecruitingPhase 1
Hoffmann-La Roche
Posted 11/11/2020

Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM

NCT05739188RecruitingPhase 1
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Posted 2/7/2023

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases

NCT05647512WithdrawnPhase 1
LaNova Medicines Limited
Posted 1/18/2023

ESMO 2024: Novel Therapies and Biomarkers Advance Bladder Cancer Treatment

  • TAR-200 monotherapy shows impressive complete response rates in BCG-unresponsive non-muscle-invasive bladder cancer, offering a potential bladder-sparing treatment option.
  • Updated AMBASSADOR trial data confirms the significant benefit of adjuvant pembrolizumab in improving disease-free survival for high-risk muscle-invasive urothelial carcinoma patients.
  • ctDNA clearance, assessed via methylation-based liquid biopsy, emerges as a promising biomarker to tailor treatment strategies and potentially de-escalate therapy in bladder cancer.
  • These advances highlight the shift towards personalized treatment approaches, aiming to optimize outcomes and minimize side effects for bladder cancer patients.

NIH Awards $4 Million Grant to Tiziana Life Sciences for Alzheimer's Disease Research

  • Tiziana Life Sciences receives a $4 million NIH grant to study intranasal anti-CD3 for Alzheimer's disease treatment.
  • The research, led by Dr. Howard Weiner at Brigham and Women’s Hospital, will advance preclinical and clinical studies.
  • Anti-CD3 aims to modulate the immune system, reduce neuroinflammation, and slow Alzheimer's progression.
  • Tiziana plans to initiate first-in-human clinical trials with intranasal anti-CD3 in Alzheimer’s patients.

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

NCT06292923RecruitingPhase 2
Tiziana Life Sciences LTD
Posted 11/15/2023

Vietnam Launches Nationwide Dengue Fever Vaccination Program with Qdenga

  • Vietnam has initiated a nationwide dengue fever vaccination program, the first of its kind in the country, targeting individuals aged four and above.
  • The vaccine being deployed is Qdenga, developed by Takeda Pharmaceutical, which has demonstrated up to 80% efficacy against all four dengue virus types.
  • Qdenga also reduces the risk of hospitalization due to dengue fever by up to 90%, offering significant protection, especially for those previously infected.
  • The vaccination program is being rolled out across approximately 200 inoculation centers by VNVC, aiming to reduce the burden of dengue fever in Vietnam.

Urinary Genomic Analysis Predicts Response to Cretostimogene in Bladder Cancer Trial

  • Analysis of the BOND-003 trial reveals that urinary genomic disease burden, assessed via the UroAmp platform, correlates with response to cretostimogene in BCG-unresponsive NMIBC patients.
  • Patients achieving complete response at 3 months showed lower genomic disease burden, with a significant reduction observed in re-induced patients achieving complete response at 6 months.
  • UroAmp signatures at 3 months predicted 12-month recurrence-free survival, distinguishing between low-risk and high-risk patients with notable differences in recurrence rates.
  • Longitudinal assessment of molecular disease burden may inform stratification strategies in future clinical trials, potentially optimizing treatment escalation and de-escalation.

Teva's TEV-749 Shows Promise in Schizophrenia Treatment with No PDSS Incidence

  • Teva's TEV-749, a once-monthly subcutaneous olanzapine injection, significantly improved schizophrenia symptoms in a Phase 3 trial, meeting its primary endpoint.
  • The SOLARIS trial demonstrated statistically significant improvements in PANSS, CGI-S, and PSP scores compared to placebo at week 8 across three dosing groups.
  • Notably, no cases of post-injection delirium/sedation syndrome (PDSS) were observed, a significant advantage over existing long-acting olanzapine treatments.
  • The safety profile of TEV-749 was consistent with oral olanzapine, with long-term safety data expected in the first half of 2025.

A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia

NCT05693935CompletedPhase 3
Teva Branded Pharmaceutical Products R&D, Inc.
Posted 1/24/2023

Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder

NCT06319170CompletedPhase 1
Teva Branded Pharmaceutical Products R&D, Inc.
Posted 3/28/2024

Sarclisa Approved for First-Line Multiple Myeloma Treatment in Transplant-Ineligible Patients

  • The FDA has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for transplant-ineligible multiple myeloma.
  • The approval was based on the IMROZ phase 3 trial, which showed a 40% reduction in disease progression or death compared to VRd alone.
  • Sarclisa is the first anti-CD38 therapy approved with VRd for this patient population, offering a new standard of care.
  • The combination demonstrated high rates of complete response and minimal residual disease negativity, improving long-term outcomes.

Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone

NCT03104842Active, Not RecruitingPhase 2
Universitätsklinikum Hamburg-Eppendorf
Posted 8/15/2017

Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years).

NCT04751877Active, Not RecruitingPhase 3
Poitiers University Hospital
Posted 7/17/2021

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

NCT02541383CompletedPhase 3
Intergroupe Francophone du Myelome
Posted 9/1/2015

MInimal Residual Disease Adapted Strategy

NCT04934475Active, Not RecruitingPhase 3
Intergroupe Francophone du Myelome
Posted 12/8/2021

Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma

NCT02874742CompletedPhase 2
Janssen Research & Development, LLC
Posted 8/29/2016

A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

NCT03319667Active, Not RecruitingPhase 3
Sanofi
Posted 12/7/2017

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

NCT02252172CompletedPhase 3
Janssen Research & Development, LLC
Posted 2/16/2015

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

NCT00644228Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 7/28/2008

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

NCT03710603Active, Not RecruitingPhase 3
Stichting European Myeloma Network
Posted 12/14/2018

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

NCT03652064Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/6/2018

Dextenza Insert Shows Strong Efficacy in Allergic Conjunctivitis Phase 3 Trial

  • A Phase 3 trial of the dexamethasone intracanalicular insert (Dextenza) met its primary endpoint, significantly reducing ocular itching associated with allergic conjunctivitis.
  • The study demonstrated statistically significant improvements in conjunctival redness and other secondary endpoints, indicating broad relief from allergic conjunctivitis symptoms.
  • Dextenza showed a favorable safety profile, with no serious adverse events reported and a low incidence of treatment-related ocular adverse events.
  • The sustained-release insert offers a preservative-free, physician-administered alternative to traditional eye drops, potentially improving patient compliance and reducing overuse.

A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

NCT04050865CompletedPhase 3
Ocular Therapeutix, Inc.
Posted 8/5/2019

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