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Clinical Trial News

BL-B01D1 Demonstrates Promising Efficacy and Safety in Urothelial Carcinoma

• BL-B01D1, an EGFR x HER3 bispecific antibody-drug conjugate, shows encouraging preliminary efficacy in previously treated urothelial carcinoma patients. • The Phase 2 trial highlights a favorable safety profile at a 2.2 mg/kg dose administered every three weeks. • Patients with one prior line of chemotherapy showed a 75% objective response rate, indicating potential in the second-line setting. • Clinical activity was observed across various levels of EGFR and HER3 expression, supporting its versatile therapeutic potential.

Incyte's Retifanlimab Shows Promise in Advanced Anal Cancer

• Phase 3 trial data reveals that retifanlimab combined with chemotherapy significantly reduces the risk of disease progression or death in patients with recurrent or metastatic squamous cell carcinoma of the anal canal. • Patients receiving the retifanlimab combination therapy experienced a median progression-free survival of 9.3 months, compared to 7.4 months in those treated with chemotherapy alone. • The combination therapy also showed potential for higher overall survival rates, although further long-term data is needed to confirm this advantage, suggesting a new treatment option for this cancer.

Keytruda Plus Lenvima with TACE Improves Progression-Free Survival in Liver Cancer

  • Phase 3 LEAP-012 trial shows Keytruda plus Lenvima with TACE significantly improved progression-free survival (PFS) in unresectable, non-metastatic hepatocellular carcinoma (HCC).
  • The combination therapy reduced the risk of disease progression or death by 34% compared to TACE alone, marking a clinically meaningful improvement.
  • Median PFS increased to 14.6 months with the Keytruda plus Lenvima regimen, compared to 10.0 months with TACE alone, demonstrating a substantial benefit.
  • While overall survival (OS) data are not yet mature, an encouraging trend toward improvement was observed with the combination therapy.

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

NCT04246177Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/22/2020

KEYTRUDA Plus Chemoradiotherapy Improves Overall Survival in High-Risk Cervical Cancer

  • KEYNOTE-A18 trial shows KEYTRUDA (pembrolizumab) plus chemoradiotherapy significantly improves overall survival in high-risk, locally advanced cervical cancer patients.
  • The KEYTRUDA regimen reduced the risk of death by 33% compared to chemoradiotherapy alone, establishing a potential new standard of care.
  • The 36-month overall survival rate was 82.6% with KEYTRUDA plus chemoradiotherapy versus 74.8% with chemoradiotherapy alone.
  • The safety profile of KEYTRUDA in combination with chemoradiotherapy was consistent with previous studies, with no new safety signals identified.

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

NCT04221945Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/12/2020

FDA Approves Niktimvo (axatilimab) for Chronic Graft-versus-Host Disease

  • The FDA approved Niktimvo (axatilimab) in August 2024 for chronic graft-versus-host disease (cGvHD) in adult and pediatric patients after failure of two prior systemic therapies.
  • Niktimvo, a first-in-class anti-CSF-1R antibody, targets inflammation and fibrosis drivers in cGvHD, offering a new approach for patients with limited options.
  • AGAVE-201 trial results, published in The New England Journal of Medicine, showed a 74% overall response rate in patients treated with the 0.3 mg/kg biweekly dose.
  • Incyte and Syndax Pharmaceuticals co-commercialize Niktimvo in the U.S., with plans for launch in early 2025; Incyte holds exclusive rights outside the U.S.

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564RecruitingPhase 2
Incyte Corporation
Posted 10/11/2024

A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

NCT04710576Active, Not RecruitingPhase 2
Syndax Pharmaceuticals
Posted 3/4/2021

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

Pfizer's Ponsegromab Shows Promise in Treating Cancer Cachexia in Phase 2 Trial

  • Pfizer's ponsegromab met its primary endpoint in a Phase 2 trial, demonstrating a significant increase in body weight compared to placebo in cancer patients with cachexia.
  • The highest dose of ponsegromab resulted in a 5.61% mean increase in body weight after 12 weeks, along with improvements in appetite, physical activity, and muscle mass.
  • The investigational monoclonal antibody targets GDF-15, a key driver of cachexia, and was generally safe and well-tolerated across all dose levels.
  • Pfizer plans to initiate registration-enabling studies in 2025 based on these positive results, potentially offering a new treatment option for this debilitating condition.

A Study of Ponsegromab in People With Heart Failure

NCT05492500TerminatedPhase 2
Pfizer
Posted 9/26/2022

Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents

NCT04710628Active, Not RecruitingPhase 2
MedSIR
Posted 9/21/2021

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

NCT05546476CompletedPhase 2
Pfizer
Posted 11/21/2022

An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia

NCT04173260Active, Not RecruitingPhase 1
University of Pennsylvania
Posted 4/29/2021

Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment

NCT05627245RecruitingPhase 1
National Cancer Institute (NCI)
Posted 3/1/2023

A Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors

NCT05824455RecruitingPhase 1
Shanghai Jun Pai Ying Shi Therapeutics Co., Ltd.
Posted 3/23/2023

A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI)

NCT06072794RecruitingPhase 1
Vitti Labs, LLC
Posted 10/6/2023

Intercept's Ocaliva Faces Setback as FDA Advisory Committee Recommends Against Full Approval for PBC

  • The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) has voted against full approval of Intercept's Ocaliva for primary biliary cholangitis (PBC).
  • The vote raises concerns about Ocaliva's clinical benefit as a second-line therapy for PBC patients, despite eight years of real-world patient experience.
  • Intercept remains committed to working with the FDA to address concerns and seek full approval for Ocaliva, with a PDUFA date set for October 15, 2024.
  • Ocaliva, a farnesoid X receptor (FXR) agonist, is currently approved under accelerated approval based on reduction in alkaline phosphatase (ALP).

ICMR Partners with Industry to Advance First-in-Human Phase 1 Clinical Trials in India

• The Indian Council of Medical Research (ICMR) has signed agreements to advance first-in-human Phase 1 clinical trials for four molecules. • Collaborations include research for multiple myeloma, Zika vaccine development, influenza vaccine trials, and CAR-T cell therapy advancements. • This initiative aims to establish India as a leader in pharmaceutical clinical development and affordable healthcare solutions. • The ICMR network includes four institutions across India, enhancing the capacity for early-phase clinical trials with robust infrastructure.

Gut Microbiome Emerges as Key Player in Cancer Immunotherapy Response, New Research Shows

  • Recent research reveals specific bacterial networks in the gut microbiome can predict cancer patients' response to immunotherapy, with Akkermansia muciniphila and Faecalibacterium prausnitzii identified as beneficial species.
  • Broad-spectrum antibiotics significantly reduce survival rates in cancer patients undergoing immunotherapy, with a meta-analysis of 46,000 patients showing a 1.7-fold higher risk of reduced survival.
  • Novel interventions, including a specialized charcoal capsule and fecal microbiota transplantation, show promising results in preserving microbiome diversity and enhancing immunotherapy effectiveness in clinical trials.

Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma

NCT04951583Active, Not RecruitingPhase 2
Centre hospitalier de l'Université de Montréal (CHUM)
Posted 11/16/2021

Maui Derm NP+PA Fall 2024 Conference to Spotlight Latest Advances in Dermatology Treatment

  • The four-day Maui Derm NP+PA Fall 2024 conference, scheduled for September 15-18 at Gaylord Opryland, will provide comprehensive updates on dermatological advances for nurse practitioners and physician assistants.
  • Leading experts will present sessions on crucial developments including new therapies for psoriasis, hidradenitis suppurativa management, and pediatric dermatology approaches.
  • The conference features interactive case discussions and survey-based participation, covering topics from blistering diseases to the latest pharmaceutical developments in dermatological care.

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