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Clinical Trial News

Dual Immunotherapy Combination Significantly Extends Survival in Advanced Cutaneous Squamous Cell Carcinoma

Monoclonal AntibodyOncology
  • A phase II clinical trial demonstrated that combining avelumab and cetuximab nearly quadrupled median progression-free survival compared to avelumab alone in patients with advanced cutaneous squamous cell carcinoma.
  • The combination therapy achieved a median progression-free survival of 11.1 months versus 3.0 months for avelumab monotherapy, with a hazard ratio of 0.48 and statistical significance.
  • The study enrolled 57 evaluable patients with advanced cSCC, showing that dual immunotherapy targeting both PD-L1 and EGFR pathways creates synergistic anti-tumor effects.
  • Results provide valuable insights for future trials combining standard-of-care immunotherapies with cetuximab to improve outcomes in this aggressive skin cancer.

Avelumab with or Without Cetuximab in Treating Patients with Advanced Skin Squamous Cell Cancer

NCT03944941Active, Not RecruitingPhase 2
Alliance for Clinical Trials in Oncology
Posted 6/17/2019

ctDNA-Based MRD Testing Shows Superior Prognostic Value in DLBCL First-Line Treatment

  • Circulating tumor DNA-based minimal residual disease (ctDNA-MRD) testing using PhasED-Seq demonstrated strong prognostic value in patients with diffuse large B-cell lymphoma following first-line treatment.
  • Patients who were ctDNA-MRD negative at end of treatment achieved 85% 36-month progression-free survival compared to only 15% in MRD-positive patients.
  • The ctDNA-MRD testing proved more prognostic than traditional measures like PET-CT scans and International Prognostic Index scores for predicting treatment outcomes.
  • Eighty-six percent of patients who relapsed within 6 months were ctDNA-MRD positive, demonstrating high sensitivity for detecting early disease relapse.

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

NCT06500273RecruitingPhase 2
Allogene Therapeutics
Posted 6/18/2024

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

NCT02972840Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 4/5/2017

ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL

NCT06693830RecruitingNot Applicable
Hua-Jay J Cherng, MD
Posted 12/11/2024

Artera's AI Algorithm Identifies Which Prostate Cancer Patients Benefit from Intensive Therapy, Earning Best of ASCO Recognition

AIPrecision Medicine
  • Artera's multimodal AI algorithm successfully identified that only 25% of high-risk prostate cancer patients derive meaningful benefit from androgen receptor pathway inhibitor intensification, potentially sparing 75% from unnecessary toxicities.
  • The company's oral presentation was selected for Best of ASCO 2025, representing the first validated AI algorithm to personalize treatment decisions for high-risk, non-metastatic prostate cancer patients.
  • The ArteraAI Prostate Test works with routine pathology and clinical data without requiring extra tissue or complex molecular testing, making it broadly scalable and cost-effective for clinical implementation.

14-Gene Molecular Assay Guides Adjuvant Chemotherapy in Early-Stage NSCLC, Reduces Recurrence Risk by 78%

Precision Medicine
  • The AIM-HIGH trial demonstrated that a 14-gene molecular assay (RiskReveal) can identify patients with stage IA-IIA nonsquamous NSCLC who benefit from adjuvant chemotherapy, showing a 78% reduction in recurrence risk.
  • Patients classified as high or intermediate risk by the assay achieved 96% disease-free survival at 24 months with chemotherapy versus 79% with observation alone (HR 0.22, P=0.0087).
  • This represents the first prospective randomized trial to show improved disease-free survival using molecular risk stratification in early-stage nonsquamous NSCLC, potentially changing treatment paradigms for patients not typically offered adjuvant therapy.
  • The trial was stopped early by the data safety monitoring board due to significant efficacy differences, with similar benefits observed even in stage IA disease patients (98% vs 78% DFS, P=0.0345).

Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer: AIM-HIGH (Adjuvant Intervention in Molecular High Risk Patients)

NCT01817192Active, Not RecruitingNot Applicable
Razor Genomics
Posted 9/11/2020

Transcripta Bio Partners with Microsoft Research to Accelerate AI-Driven Disease Gene Discovery

AIDrug Discovery
  • Transcripta Bio announced a research collaboration with Microsoft Research to accelerate disease-gene association discovery using AI and large-scale transcriptomic data.
  • The partnership combines Transcripta Bio's proprietary Drug-Gene Atlas containing over a billion gene responses with Microsoft Research's machine learning expertise.
  • The collaboration aims to identify novel therapeutic opportunities faster than conventional methods by analyzing chemotranscriptomic datasets for disease-gene associations.
  • Microsoft Research will focus on rare disease genomics while Transcripta Bio contributes its transcriptomics-driven platform for drug discovery acceleration.

Subtle Medical Expands AI-Powered MRI Enhancement Technology Across Latin America with ANVISA Approval in Brazil

AI
  • Subtle Medical's SubtleHD™ AI technology received ANVISA regulatory approval and is now commercially available in Brazil, marking significant expansion into Latin America's medical imaging market.
  • The FDA-cleared deep learning technology enhances MRI image quality and delivers up to 80% faster scan times, addressing critical infrastructure gaps in Brazil where there are only 14.5 MRI units per million people.
  • SubtleHD™ enables healthcare providers to unlock additional scan capacity without new hardware purchases, particularly valuable given that over 66% of MRI scanners in the region are more than six years old.

Beam Therapeutics and Capricor Secure FDA Orphan Drug Designations for Rare Disease Treatments

Rare DiseaseFDA Approval
  • Beam Therapeutics received FDA orphan drug designation for its sickle cell disease treatment, providing regulatory incentives for this rare genetic disorder affecting hemoglobin production.
  • Capricor Therapeutics obtained orphan drug designation for its Becker muscular dystrophy therapy, targeting this progressive muscle-wasting condition.
  • Both designations offer companies seven years of market exclusivity, tax credits, and reduced regulatory fees to encourage development of treatments for rare diseases affecting fewer than 200,000 patients in the United States.

Dual-Targeted CAR-T Therapy KITE-363 Shows 87% Response Rate in Relapsed B-Cell Lymphoma

CAR-TOncology
  • KITE-363, a dual CD19/CD20-targeted CAR-T therapy, achieved an 87% objective response rate with 78% complete responses in CAR-T naive patients with relapsed/refractory large B-cell lymphoma.
  • The therapy demonstrated superior CAR-T cell expansion compared to existing treatments, with peak levels 3-5 fold higher than axicabtagene ciloleucel.
  • Safety profile showed manageable toxicity with no grade 3 or 4 cytokine release syndrome or neurotoxicity in primary refractory patients at the recommended dose.
  • Primary refractory patients achieved 80% response rates with 67% complete responses, addressing a critical unmet need in this difficult-to-treat population.

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

NCT04989803RecruitingPhase 1
Kite, A Gilead Company
Posted 10/27/2021

Epcoritamab Demonstrates Durable 3-Year Remissions in Relapsed/Refractory Large B-Cell Lymphoma

Drug ApprovalOncology
  • Epcoritamab-bysp achieved durable complete responses in patients with relapsed/refractory large B-cell lymphoma, with 96% of complete responders at 2 years maintaining remission at 3 years.
  • The median duration of complete response was 36.1 months, with the longest ongoing complete response exceeding 43 months in the EPCORE NHL-1 study.
  • Among patients who discontinued treatment for reasons other than disease progression, complete response was maintained for a median of 14 months after stopping therapy.
  • The bispecific T-cell engager demonstrated manageable safety profile with COVID-19, cytokine release syndrome, and diarrhea as the most common treatment-emergent adverse events.

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

NCT03274492Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/16/2017

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

NCT03930953Active, Not RecruitingPhase 1
Celgene
Posted 5/20/2019

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

NCT06356129RecruitingPhase 3
Celgene
Posted 6/19/2024

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

NCT05283720RecruitingNot Applicable
Genmab
Posted 6/14/2022

The Pathogenesis and Prognostic Factors of Lymphoma

NCT06203652Recruiting
Shanghai Zhongshan Hospital
Posted 6/5/2023

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

NCT03625037Active, Not RecruitingPhase 1
Genmab
Posted 6/26/2018

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

FDA Issues Draft Guidance to Streamline Color Additive Replacement in Drug Products

FDA Approval
  • The FDA has released draft guidance allowing most color additive replacements in approved drug products to be submitted as moderate changes requiring only 30-day notification rather than prior approval supplements.
  • The new guidance applies to prescription drugs, over-the-counter products, and compounded drugs, requiring that replacement color additives be listed in FDA's color additive regulations.
  • Manufacturers must provide comprehensive documentation including stability studies, dissolution testing, and updated labeling when replacing color additives in drug formulations.
  • The regulatory change addresses situations where color additives must be removed for safety reasons or replaced for business decisions while maintaining product quality standards.

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