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Clinical Trial News

Chemotherapy-Free Regimens and CAR-T Therapies Transform B-Cell Malignancy Treatment Paradigms

CAR-TTargeted TherapyDrug Approval
  • Chemotherapy-free regimens are shifting treatment paradigms in mantle cell lymphoma, with BTK inhibitor-based therapies increasingly used for high-risk patients with TP53 mutations who respond poorly to traditional chemotherapy.
  • The FDA approval of lisocabtagene maraleucel for double-refractory chronic lymphocytic leukemia provides a new treatment option for patients who have failed both BTK inhibitors and BCL2 inhibitors like venetoclax.
  • Selective BTK inhibitors zanubrutinib and acalabrutinib are replacing ibrutinib in clinical practice, with combination regimens including venetoclax showing promising results in frontline CLL therapy.
  • Novel combination strategies including acalabrutinib plus venetoclax and triplet regimens with obinutuzumab are expanding treatment options for CLL patients, though regulatory approval is still pending.

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

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

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

NCT02242942Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2014

ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

NCT02858258RecruitingPhase 3
Prof. Dr. M. Dreyling (co-chairman)
Posted 7/1/2016

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma

NCT03570892Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 5/7/2019

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

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma

NCT03223610RecruitingPhase 1
National Cancer Institute (NCI)
Posted 2/9/2018

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

Expert Panel Identifies Key Patient Factors for Optimizing Immunotherapy Selection in PD-L1 Negative NSCLC

  • Oncologists recommend waiting for PD-L1 test results before initiating treatment in metastatic NSCLC patients without visceral crisis, as PD-L1 status guides immunotherapy selection.
  • For PD-L1 negative patients, dual immunotherapy with nivolumab plus ipilimumab shows particular benefit in smokers, poorly differentiated tumors, and those with KRAS co-mutations with STK11 or KEAP1.
  • The CheckMate 9LA regimen combining dual immunotherapy with reduced chemotherapy cycles may offer better tolerability compared to standard chemotherapy plus pembrolizumab combinations.
  • Patient factors including smoking history, tumor mutational burden, and histologic differentiation help determine whether CTLA-4 inhibition should be added to PD-1 blockade in treatment planning.

Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)

NCT03302234CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 12/14/2017

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

NCT03215706CompletedPhase 3
Bristol-Myers Squibb
Posted 8/24/2017

Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

NCT02659059CompletedPhase 2
Bristol-Myers Squibb
Posted 2/15/2016

Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer

NCT02888743Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 8/14/2017

An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

NCT02869789CompletedPhase 4
Bristol-Myers Squibb
Posted 10/5/2016

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

NCT02477826CompletedPhase 3
Bristol-Myers Squibb
Posted 8/5/2015

Atezolizumab Shows Consistent Efficacy in Cervical Cancer Regardless of PD-L1 Status, BEATcc Trial Analysis Reveals

Monoclonal Antibody
  • A post hoc analysis of the phase 3 BEATcc trial demonstrates that atezolizumab combined with chemotherapy and bevacizumab provides consistent clinical benefits in cervical cancer patients irrespective of PD-L1 expression levels.
  • Patients with PD-L1 CPS <1 showed similar progression-free survival improvements (HR 0.48) compared to those with CPS ≥1 (HR 0.54), suggesting PD-L1 may not serve as a predictive biomarker.
  • The findings potentially broaden the eligible patient population for this immunotherapeutic combination, addressing an unmet need for patients with low or unknown PD-L1 status.
  • Interim overall survival data showed median values of 37.3 months versus 19.2 months in the low PD-L1 group, with final results expected in 2026.

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

NCT03635567CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 10/25/2018

Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix

NCT03556839Active, Not RecruitingPhase 3
Grupo Español de Investigación en Cáncer de Ovario
Posted 9/25/2018

AbbVie Secures $2 Billion Option Deal for Gilgamesh's Next-Generation Psychedelic Therapies

  • AbbVie has agreed to pay $65 million upfront for an option deal with Gilgamesh Pharmaceuticals, with potential payments reaching $1.95 billion for neuroplastogen compounds targeting mood and anxiety disorders.
  • The partnership focuses on developing next-generation psychiatric medicines that harness psychedelic mechanisms while reducing psychoactive effects like hallucinations that require controlled clinical settings.
  • Gilgamesh's pipeline includes GM-1020, an oral NMDA receptor blocker in Phase 2a for major depressive disorder, and GM-2505, a serotonin 5-HT2A agonist also in Phase 2 development.
  • The deal represents AbbVie's continued expansion into neuroscience following recent acquisitions including the $9 billion Cerevel Therapeutics purchase and reflects growing pharmaceutical industry interest in psychedelic-based therapies.

University of Wisconsin Researchers Develop Personalized Cancer Vaccines Using Pyroptotic Vesicles to Prevent Tumor Recurrence

  • University of Wisconsin-Madison researchers have developed personalized cancer vaccines using pyroptotic vesicles, tiny sacs from dying cancer cells, that significantly extended survival in mouse models of triple-negative breast cancer and melanoma.
  • The engineered vesicles contain tumor-specific antigens and are embedded in hydrogels implanted at surgical sites, creating localized immune responses that reduce systemic side effects compared to traditional cancer vaccines.
  • Mice receiving the highest doses of the experimental treatment remained cancer-free throughout the study, with researchers demonstrating potential applications for other recurring cancers like pancreatic cancer and glioblastoma.
  • The approach represents the first demonstration of pyroptotic vesicles' effectiveness in preventing cancer recurrence, with the research team being among the first to identify these cellular byproducts.

Dupilumab Treatment for Atopic Dermatitis Linked to Increased Psoriasis Risk in Large-Scale Study

Monoclonal Antibody
  • A large retrospective cohort study of 19,720 patients found that dupilumab treatment for atopic dermatitis was associated with a 58% increased risk of developing psoriasis compared to other systemic therapies.
  • The 3-year cumulative incidence of psoriasis was 2.86% in dupilumab-treated patients versus 1.79% in those receiving alternative systemic treatments, with a number needed to harm of 94.
  • Despite the elevated relative risk, researchers emphasized that the absolute risk increase remains small at 1.07 percentage points over three years, requiring careful consideration against dupilumab's established therapeutic benefits.

Grifols' Fibrinogen Concentrate BT524 Demonstrates Non-Inferiority in Phase III Trial for Surgical Bleeding

  • Grifols' fibrinogen concentrate BT524 met its primary endpoint in the Phase III AdFIrst trial, demonstrating non-inferiority to standard of care for treating bleeding in acquired fibrinogen deficiency during major surgery.
  • The study showed BT524 reduced intraoperative blood loss by 279 mL compared to fresh frozen plasma/cryoprecipitate, with significantly lower thromboembolic events.
  • BT524 is on track for European launch later this year and U.S. approval in early 2026, potentially transforming hemorrhage management in surgical settings.
  • The positive results were published in The Lancet's eClinicalMedicine and presented at the International Society on Thrombosis and Haemostasis Congress.

Adjusted Fibrinogen Replacement Strategy

NCT03444324CompletedPhase 3
Biotest
Posted 4/3/2018

dGenThera and Nusano Partner to Scale Astatine-211 Production for Next-Generation Cancer Therapy

Precision MedicineOncology
  • dGenThera and Nusano signed a letter of intent to provide reliable access to high-purity astatine-211, a best-in-class alpha-emitting isotope for targeted cancer therapy.
  • Nusano's breakthrough accelerator technology will increase global At-211 supply by 100-fold through a facility with alpha beam current 10 times greater than all comparable systems combined.
  • The partnership enables dGenThera to advance its theranostic molecular pairs platform, which uses covalently-bonded At-211 to create precision radiotherapies that can cross the blood-brain barrier.
  • At-211's unique properties include pure alpha emission with no problematic daughter isotopes and a 7.2-hour half-life ideal for systemic delivery and tumor targeting.

Historical Challenges in NF1-Associated Plexiform Neurofibroma Treatment Drive Development of Targeted Therapies

Targeted TherapyPrecision Medicine
  • Previous therapies for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) have shown limited efficacy and high toxicity, particularly in tumor shrinkage and symptom control.
  • Approximately 50% of individuals with NF1 develop associated plexiform neurofibromas, which are slow-growing tumors involving multiple nerves that rarely allow complete surgical resection.
  • The indolent growth pattern of these tumors has posed longstanding challenges in developing systemic therapies that demonstrate clear therapeutic effects while maintaining long-term tolerability.
  • Tumor heterogeneity and resistance mechanisms have highlighted the need for combination therapies and molecular profiling-based patient selection to improve treatment outcomes.

Dendritic Cell Therapy Shows Significant Survival Benefit for Recurrent Glioblastoma Patients

  • A phase III clinical trial demonstrated that dendritic cell therapy (DCVax-L) extended median overall survival to 13.2 months in recurrent glioblastoma patients compared to 7.8 months in controls, representing a 68% increase in survival.
  • Long-term survival outcomes showed 20.7% of treated patients alive at 24 months after recurrence, compared to only 9.6% in the control group.
  • The therapy works by training the patient's immune system to recognize and attack glioblastoma tumor cells using autologous dendritic cells loaded with tumor antigens.
  • Dendritic cell vaccination is generally well-tolerated with mostly mild side effects, offering a safer alternative to traditional chemotherapy for this aggressive brain cancer.

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