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Clinical Trial News

Researchers Unveil New Strategies to Harness Tumor Microenvironment for Enhanced Cancer Immunotherapy

Drug Approval
  • Researchers at the 2025 ASCO Annual Meeting revealed how the tumor microenvironment's complex balance of pro-tumor and anti-tumor immune forces can be manipulated to improve immunotherapy responses.
  • A clinical study combining the JAK inhibitor itacitinib with pembrolizumab achieved a 67% overall response rate in non-small cell lung cancer patients by resetting chronic interferon signaling.
  • The dual blockade of PD-1 and LAG3 with relatlimab plus nivolumab produces "marathon runner" T-cells with enhanced durability compared to PD-1 inhibition alone.

A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

NCT01472198CompletedPhase 2
Gilead Sciences
Posted 11/1/2011

Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors

NCT03386721TerminatedPhase 2
Hoffmann-La Roche
Posted 2/19/2018

Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors

NCT02301130CompletedPhase 1
Kyowa Kirin, Inc.
Posted 11/26/2014

HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer

NCT06014190RecruitingPhase 2
Hansoh BioMedical R&D Company
Posted 12/18/2023

Study of E7046 in Subjects With Selected Advanced Malignancies

NCT02540291TerminatedPhase 1
Eisai Inc.
Posted 7/30/2015

A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers

NCT01002963CompletedPhase 1
Pfizer
Posted 9/1/2009

Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04612751Active, Not RecruitingPhase 1
AstraZeneca
Posted 2/2/2021

A Study of Safety, Pharmacokinetics, Pharmacodynamics of JNJ-61610588 in Participants With Advanced Cancer

NCT02671955TerminatedPhase 1
Janssen Research & Development, LLC
Posted 1/1/2016

A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

NCT02752074CompletedPhase 3
Incyte Corporation
Posted 6/21/2016

Novartis Secures FDA Approval for Leqvio, First Twice-Yearly Cholesterol Drug

Drug Approval
  • Novartis has received FDA approval for Leqvio (inclisiran), a first-in-class siRNA therapy that reduces LDL cholesterol with just two injections per year.
  • The drug achieved up to 52% LDL cholesterol reduction in phase 3 trials when added to statins in patients with high cholesterol and atherosclerotic cardiovascular disease.
  • Approximately 16 million Americans with ASCVD taking statins are not reaching their recommended LDL cholesterol targets, representing a significant market opportunity.
  • The approval comes after a one-year delay due to manufacturing facility issues, with Novartis transferring production to its own Austrian facility.

MammaPrint 70-Gene Assay Shows Strong Predictive Value for Chemotherapy Benefit in HR+/HER2- Breast Cancer

Real World Evidence
  • The MammaPrint 70-gene assay demonstrated significant predictive utility for chemotherapy benefit in hormone receptor-positive, HER2-negative early-stage breast cancer patients, with the strongest benefit observed in High Risk 2 patients.
  • Patients with MammaPrint High Risk 2 breast cancer showed maximum absolute reduction benefit of 14.2% with chemotherapy, while Low and Ultralow risk categories showed minimal benefit of 1.7% and less than 1.0% respectively.
  • Real-world evidence from the FLEX study supports using MammaPrint to guide treatment decisions in older patients aged 70 and above, potentially sparing low-risk patients from unnecessary chemotherapy while identifying those who may benefit despite advanced age.
  • Multivariate analysis confirmed significant interaction between MammaPrint Index and chemotherapy benefit, with pre- or peri-menopausal status significantly associated with greater chemotherapy benefit.

Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes

NCT00433589CompletedPhase 3
European Organisation for Research and Treatment of Cancer - EORTC
Posted 2/1/2007

MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

NCT03053193Recruiting
Agendia
Posted 4/28/2017

ERA 2025 to Feature Pivotal Nephrology Trials Including CONFIDENCE, ACHIEVE, and VISIONARY Studies

  • The 62nd European Renal Association Congress in Vienna will present seven late-breaking clinical trials addressing chronic kidney disease, dialysis patients, and glomerular disease developments.
  • The CONFIDENCE trial evaluates simultaneous initiation of empagliflozin and finerenone in 1,664 patients with type 2 diabetes and chronic kidney disease, addressing a critical evidence gap in combination therapy.
  • The ACHIEVE trial represents the largest international study of spironolactone in 2,538 dialysis patients, examining cardiovascular outcomes in this high-risk population.
  • The VISIONARY trial presents interim results for sibeprenlimab, an APRIL inhibitor targeting the underlying immunological basis of IgA nephropathy in 530 patients.

Novoxel and GPOphtho Partner to Expand Access to FDA-Cleared Tixel Device for Dry Eye Treatment Across US

  • Novoxel Inc. and GPOphtho have finalized a strategic agreement to expand access to the Tixel device family for treating dry eye and aesthetic procedures nationwide.
  • The Tixel i device specifically targets Meibomian Gland Dysfunction (MGD) with a 2-minute treatment for both eyes, supported by recent clinical trial data showing safety and efficacy.
  • The FDA-cleared device uses proprietary Thermo-Mechanical Action technology to provide non-invasive treatments without needles, bleeding, or radiation exposure.
  • The partnership enables eyecare physicians to integrate both functional dry eye treatments and cosmetic procedures, creating new revenue streams through discounted pricing packages.

Nxera Pharma Achieves Key Development Milestone in Eli Lilly Collaboration for Diabetes and Metabolic Disease Treatments

Drug Discovery
  • Nxera Pharma has achieved a significant development milestone in its multi-target collaboration with Eli Lilly targeting diabetes and metabolic diseases, triggering an undisclosed milestone payment.
  • The milestone validates Nxera's NxWave™ platform for identifying small molecule binders to GPCR targets and solving receptor structures to reveal binding sites.
  • Under the collaboration agreement established in 2022, Nxera is eligible to receive up to $694 million in development and commercial milestones plus tiered royalties on global sales.
  • Lilly will now assume responsibility for further development and commercialization of the compounds identified through Nxera's proprietary drug discovery platform.

Mirvie's RNA Blood Test Predicts Preeclampsia Risk Months Before Symptoms in Major Study

Precision Medicine
  • Mirvie's blood test successfully identified 91% of preterm preeclampsia cases in women over 35 without pre-existing conditions, using RNA signatures detectable at 17.5-22 weeks gestation.
  • The study analyzed over 9,000 pregnancies and discovered molecular signatures that distinguish between severe and mild hypertensive disorders of pregnancy for the first time.
  • Preeclampsia rates have nearly doubled in the past decade, now affecting 1 in 12 pregnancies, highlighting the urgent need for better predictive tools.
  • The clinically validated test will be available under the Encompass brand, enabling proactive care plans including low-dose aspirin therapy months before symptoms appear.

MHRA Grants Conditional Approval for CAR-T Therapy Aucatzyl to Treat Relapsed B-Cell ALL

CAR-TDrug Approval
  • The MHRA granted conditional marketing authorization for obecabtagene autoleucel (Aucatzyl), a CAR-T cell therapy for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia on April 25, 2025.
  • The European Medicines Agency's CHMP adopted a positive opinion for Aucatzyl on May 22, 2025, recommending conditional approval for adults aged 26 years and older with the same indication.
  • B-cell precursor ALL is a blood cancer affecting white blood cells where bone marrow produces abnormal, immature B-lymphocytes that grow and divide rapidly.
  • This approval represents a significant advancement in CAR-T cell therapy for treating this aggressive form of blood cancer in patients who have failed previous treatments.

Real-World Data Confirms Low-Severity Safety Profile for Lisocabtagene Maraleucel Across Blood Cancer Settings

CAR-TReal World Evidence
  • Real-world data from 877 patients and clinical trial data from 702 patients demonstrate that most cytokine release syndrome and neurological events with lisocabtagene maraleucel occur within 15 days of infusion and are not severe.
  • Among patients experiencing late-onset adverse events after day 15, the vast majority were grade 1/2 events that resolved without requiring intensive care unit-level management.
  • The findings support optimized monitoring strategies that could improve patient access to CAR-T therapy while maintaining safety standards across multiple blood cancer indications.

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

NCT03483103CompletedPhase 2
Juno Therapeutics, a Subsidiary of Celgene
Posted 7/27/2018

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT03331198RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/27/2017

Sintilimab/Chidamide Combination Shows Promising Results in Early-Stage Natural Killer T-Cell Lymphoma

  • The phase 2 SCENT-2 trial demonstrated that sintilimab plus chidamide followed by P-GemOx achieved a 95.7% objective response rate with 93.6% complete response in 47 patients with treatment-naïve early-stage ENKTL.
  • At 17 months median follow-up, the combination showed excellent survival outcomes with 1-year progression-free survival of 95.7% and overall survival of 95.3%.
  • The treatment regimen demonstrated manageable toxicity profile, with most adverse effects attributed to the P-GemOx chemotherapy component rather than the immunotherapy combination.
  • Results suggest this novel chemotherapy-reduced approach may serve as an effective induction regimen for treatment-naïve patients with early-stage extranodal natural killer T-cell lymphoma.

Sintilimab in Combination With Chidamide in Newly Diagnosed ENKTCL

NCT04994210RecruitingPhase 2
Sun Yat-sen University
Posted 10/4/2021

Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL

NCT03820596CompletedPhase 1
Huiqiang Huang
Posted 3/29/2019

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