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Clinical Trial News

AstraZeneca Advances Two Phase III Trials Testing Baxdrostat Combination Therapy for Cardiovascular and Kidney Disease

  • AstraZeneca is conducting two Phase III clinical trials evaluating baxdrostat in combination with dapagliflozin for patients with cardiovascular disease and chronic kidney disease.
  • The first study targets patients aged 40 and older with type 2 diabetes, established cardiovascular disease, and hypertension, focusing on heart failure and cardiovascular outcomes.
  • The second trial investigates baxdrostat/dapagliflozin efficacy in patients 18 years and older with chronic kidney disease and hypertension over a 24-month treatment period.
  • Both studies include run-in periods with dapagliflozin monotherapy and feature comprehensive follow-up protocols with visits extending up to 34 weeks in the cardiovascular trial.

Harbinger Health's Blood-Based Multi-Cancer Test Shows Promise in High-Risk Obesity Population at ASCO 2025

  • Harbinger Health presented clinical data at ASCO 2025 demonstrating their blood-based multi-cancer early detection test achieved 25.8% sensitivity for early-stage cancers and 80.3% for late-stage cancers at 98.3% specificity in high-risk populations.
  • The CORE-HH study enrolled 8,095 subjects from 126 U.S. sites, with the obesity cohort of 762 individuals showing the test's ability to detect cancers that disproportionately affect obese patients and lack established screening programs.
  • The company's ctDNA-methylation-based reflex testing system introduces a novel "intrinsic accuracy" metric of 36%, measuring the test's ability to correctly identify both cancer presence and tissue of origin.
  • In a modeled 100,000-person cohort, the test identified 51 of 86 pancreaticobiliary cancers, including 8 of 31 early-stage cases, addressing a critical gap for cancers without routine screening programs.

Development and Validation of Harbinger Health Test for Early Cancer Detection

NCT05435066Completed
Harbinger Health
Posted 6/21/2022

Trinity Life Sciences Partners with Ontada to Enhance Real-World Oncology Data Analytics for Drug Development

OncologyAI
  • Trinity Life Sciences has formed a strategic collaboration with Ontada, a McKesson business, to provide life sciences companies with real-time oncology insights for pre- and post-launch decision making.
  • The partnership combines Trinity's commercial analytics expertise with Ontada's iKnowMed electronic health record system, which contains data from over 2.4 million patient records across 80+ tumor types.
  • The collaboration aims to accelerate commercial decision-making in community oncology through AI-enhanced analytics and deeper patient journey insights.
  • Ontada's real-world data platform serves more than 2,400 oncology community-based providers across the United States through The US Oncology Network and Onmark practices.

NAPOLI 3 Post-Hoc Analysis Identifies Characteristics Associated with Long-Term Survival in Metastatic Pancreatic Cancer

Oncology
  • A post-hoc analysis of the Phase III NAPOLI 3 trial identified characteristics associated with long-term survival in metastatic pancreatic adenocarcinoma patients treated with the NALIRIFOX regimen.
  • Long-term survivors (n=15) achieved a median overall survival of 19.5 months, with younger age at diagnosis and specific tumor locations being key factors.
  • Dose modifications and treatment delays enabled patients to receive higher cumulative doses and stay on treatment longer, contributing to improved outcomes.
  • The findings provide important insights for a cancer where fewer than 20% of patients survive longer than one year.

Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma

NCT01526135CompletedPhase 3
UNICANCER
Posted 4/16/2012

Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer

NCT01494506CompletedPhase 3
Merrimack Pharmaceuticals
Posted 11/1/2011

Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

NCT00112658CompletedPhase 2
UNICANCER
Posted 11/1/2004

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

NCT00844649CompletedPhase 3
Celgene
Posted 3/1/2009

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

NCT04083235CompletedPhase 3
Ipsen
Posted 2/11/2020

Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer

NCT01804790CompletedPhase 3
UNICANCER
Posted 1/1/2012

Large-Scale Study Reveals Significant Racial Disparities in Early-Onset Colorectal Cancer Diagnosis

Real World EvidenceOncology
  • A comprehensive analysis of 105,000 colorectal cancer patients found that Black, Hispanic, Latino, and American Indian populations are disproportionately represented in early-onset cases diagnosed before age 50.
  • Early-onset patients were significantly more likely to be diagnosed at advanced stages (III and IV), with a 10 percentage point higher likelihood compared to average-onset patients.
  • Current screening guidelines starting at age 45 fail to cover over half of early-onset patients, particularly those under 44, highlighting the need for risk-based screening approaches.
  • The study revealed diagnostic delays of 4-8 months longer for younger patients, emphasizing the urgent need for reduced time from symptom onset to definitive diagnosis.

Facet Life Sciences Partners with Nucleus to Advance Radiopharmaceutical Development Through Regulatory Expertise

FDA Approval
  • Facet Life Sciences has announced a strategic partnership with Nucleus, a leader in diagnostic and therapeutic radiopharmaceuticals, to serve as their official regulatory partner for U.S. FDA affairs.
  • Facet's regulatory team brings extensive experience with over 40 FDA applications submitted including INDs, NDAs, BLAs, and ANDAs, plus leadership of more than 75 FDA meetings across multiple divisions.
  • The partnership aims to accelerate radiopharmaceutical product development by providing critical regulatory guidance and ensuring effective navigation of the FDA approval process.
  • Both the FDA and Society of Nuclear Medicine and Molecular Imaging recognize Facet as experts in diagnostic and therapeutic radiopharmaceuticals, positioning them to drive innovation in this specialized field.

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.

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

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

NCT06500273RecruitingPhase 2
Allogene Therapeutics
Posted 6/18/2024

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

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