Libtayo (cemiplimab-rwlc) / Regeneron 
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 1 Disease   67 Trials   67 Trials   1555 News 


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  • ||||||||||  ASP8374 / Astellas
    Trial completion date:  ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) -  Jan 15, 2025   
    P1,  N=14, Active, not recruiting, 
    Trial completion date: Dec 2024 --> Jun 2025
  • ||||||||||  Trial completion date, Checkpoint inhibition, IO biomarker:  Exercise to Boost Response to Checkpoint Blockade Immunotherapy (clinicaltrials.gov) -  Jan 13, 2025   
    P1,  N=22, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Jan 2025 --> Sep 2025 Trial completion date: Dec 2024 --> Dec 2025
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment closed:  A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer (clinicaltrials.gov) -  Jan 9, 2025   
    P2,  N=34, Active, not recruiting, 
    Trial completion date: Dec 2024 --> Dec 2025 Recruiting --> Active, not recruiting
  • ||||||||||  nezastomig (REGN5678) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
    A phase 1/2 study of nezastomig (anti-PSMA (Level 1, West Hall; Poster Bd #: M12) -  Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_585;    
    P1/2
    Dose expansion primary objective is to assess efficacy of nezastomig (measured by objective response rate per modified Prostate Cancer Working Group 3 criteria [mCRPC cohorts] and per Response Evaluation Criteria in Solid Tumors version 1.1 [ccRCC cohorts]). The study is open and enrolling; 101 pts (97 with mCRPC; 4 with ccRCC) have been enrolled as of September 12, 2024.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron, Cabometyx (cabozantinib tablet) / Exelixis
    Development of an ex-vivo platform to model immunotherapy in kidney cancer. (Level 1, West Hall; Poster Bd #: H27) -  Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_509;    
    The drug treatment experiments conducted on the slices demonstrate the potential of PCTS as a preclinical tool for screening effective therapies for primary ccRCC, including immunotherapeutic approaches, which has been challenging in previous animal models. Our findings suggest that the triplet regimen (cabo+cemi+fin) may offer greater efficacy compared to the cabo+cemi or cemi+fin.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    EPIC-B: Phase II trial of cemiplimab as first-line treatment in advanced penile carcinoma. (Level 1, West Hall; Poster Bd #: D8) -  Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_360;    
    Single agent cemiplimab as a first line treatment for la/mPC in the EPIC-B trial demonstrates efficacy with a generally manageable toxicity profile. This study adds to the evidence that single agent cemiplimab is a viable treatment for la/mPC patients for whom chemotherapy is not an option.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Initial Experience With Cemiplimab In Locally Advanced And Metastatic Vulvar Cancer (Exhibition hall) -  Jan 4, 2025 - Abstract #ESGO2025ESGO_1773;    
    PDL-1 CPS score differed significantly between response group and non-response group: PDL-1 CPS score (response group: median 81; non-response group: median 17.5; p=0.012).Conclusion Therapy with cemiplimab is feasible and demonstrates clinically relevant therapeutic effects in advanced and metastatic vulvar cancer. Given the limited therapeutic options, this could represent an important treatment perspective for this cohort.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Single Centre Experience Of Cemiplimab In Recurrent/Metastatic Cervical Cancer (Poster area) -  Jan 4, 2025 - Abstract #ESGO2025ESGO_1136;    
    Conclusion Our data confirms Cemiplimab as an active agent in the second line setting for those who are unable to receive it first line with about a third of patients deriving benefit, in those who have responded there is a suggestion of prolonged disease free response. However, a quarter of patients received 2 cycles or less strenghthening the rationale of using Immunotherapy first line in combination with chemotherapy for those who are eligible.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Clinical Value Of Systemic Immune-Inflammation Index (SII) In Patients With Recurrent Cervical Cancer Treated With Cemiplimab. (Poster area) -  Jan 4, 2025 - Abstract #ESGO2025ESGO_747;    
    Using the SII cutoff of 750, for OS the 14 patients with values lower than 750 have a median OS of 6.2 months and the 21 patients with higher values have a median OS of 11.1 months (p=0.84). Also for PFS no differences was shown with the cutoff of 750 (median PFS of 2.3 months below 750 and median PFS of 3.4 months above 750, p=0.51).Conclusion Despite the retrospective nature of this study and the small sample size, in RCC treated with Cemiplimab, SII was not correlated with clinical outcomes.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Checkpoint-Inhibitor Resistance In Vulvar Cancer (Poster area) -  Jan 4, 2025 - Abstract #ESGO2025ESGO_647;    
    There are some encouraging case reports about the use of checkpoint-inhibitors, especially the PD-1 Inhibitor Cemiplimab...Subsequent radiotherapy with Cisplatin sensitizing led to complete response, lasting more than five month after the end of therapy until today...The reasons for resistance to Checkpoint-Inhibitor treatment are currently not known. Future studies examining different specific biomarkers are needed to improve the treatment of locally advanced vulvar carcinomas.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion date, Trial initiation date, Trial primary completion date:  Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients with Advanced Leiomyosarcoma (clinicaltrials.gov) -  Jan 3, 2025   
    P2,  N=16, Not yet recruiting, 
    Future studies examining different specific biomarkers are needed to improve the treatment of locally advanced vulvar carcinomas. Trial completion date: Dec 2025 --> Dec 2027 | Initiation date: Dec 2024 --> Apr 2025 | Trial primary completion date: Dec 2025 --> Dec 2027
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion date, Trial primary completion date:  Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer (clinicaltrials.gov) -  Dec 27, 2024   
    P1,  N=13, Active, not recruiting, 
    Trial completion date: Dec 2025 --> Dec 2027 | Initiation date: Dec 2024 --> Apr 2025 | Trial primary completion date: Dec 2025 --> Dec 2027 Trial completion date: Dec 2025 --> Sep 2025 | Trial primary completion date: Dec 2024 --> Sep 2024
  • ||||||||||  Journal:  Cancer and Hidradenitis Suppurativa. (Pubmed Central) -  Dec 11, 2024   
    Other factors that have occasionally been associated with HS-related SCC include treatment with a tumor necrosis factor-alpha inhibitor (such as infliximab and adalimumab), genodermatoses (such as keratitis-ichthyosis-deafness syndrome and Dowling-Degos disease), and paraneoplastic syndromes (such as hypercalcemia, hypercalcemia-leukocytosis, and paraneoplastic neuropathy)...The potential role of human papillomavirus vaccination for cancer prevention and early treatment of SCC with targeted therapy (with an epidermal growth factor inhibitor such as cetuximab) and/or checkpoint inhibitor immunotherapy (such as cemiplimab and pembrolizumab) remains to be determined...Also, both primary cancers (such as cutaneous squamous cell carcinoma and mucinous adenocarcinoma) and breast cancer skin metastases can masquerade as hidradenitis suppurativa lesions. Therefore, when a lesion is located at a current or prior site of hidradenitis suppurativa that is new or rapidly growing and/or does not respond to hidradenitis suppurativa-directed therapy, prompt evaluation to establish or exclude the diagnosis of cancer should be considered.
  • ||||||||||  ubamatamab (REGN4018) / Regeneron
    P1 data, Journal:  Translational findings support regimen selection for first-in-human study of ubamatamab (MUC16? (Pubmed Central) -  Dec 9, 2024   
    Integrating preclinical and clinical data determined a target trough concentration range of 5-30?mg/L, which supports evaluation of ubamatamab 250?mg with or without cemiplimab and 800?mg monotherapy once every 3?weeks in expansion cohorts. Preclinical data (cytokine release, tumor regression, monkey PK) had translational value in supporting regimen selection in dose escalation and subsequently in dose expansion after integration with patient data from dose escalation.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment closed, Trial completion date, Trial primary completion date:  NCI-2018-01313: Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery (clinicaltrials.gov) -  Dec 9, 2024   
    P2,  N=44, Active, not recruiting, 
    Preclinical data (cytokine release, tumor regression, monkey PK) had translational value in supporting regimen selection in dose escalation and subsequently in dose expansion after integration with patient data from dose escalation. Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
  • ||||||||||  Magnesium Is Associated with Favorable Outcomes of Cancer Patients Treated with Immune Checkpoint Inhibitors () -  Dec 7, 2024 - Abstract #ASH2024ASH_8424;    
    These findings underscore the predictive value of serum magnesium levels in evaluating clinical outcomes among patients receiving ICIs therapy.Conclusion : This multicenter study demonstrates that patients receiving ICIs exhibit significantly improved outcomes among those with elevated serum magnesium levels compared to those with low levels. Further prospective validation studies are essential to evaluate magnesium levels in ICI-treated patients and to supplement magnesium preparations in patients with magnesium deficiency to confirm these findings.
  • ||||||||||  Mekinist (trametinib) / Novartis, BeiGene, Libtayo (cemiplimab-rwlc) / Regeneron, Tafinlar (dabrafenib) / Novartis
    Enrollment closed, IO biomarker:  Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer (clinicaltrials.gov) -  Dec 2, 2024   
    P2,  N=16, Active, not recruiting, 
    Through the publication of the present case report and literature review, the present article aimed to enhance the understanding of this condition, providing valuable diagnostic and therapeutic information about the spectrum of mucosal involvement among drug-related toxicities of current oncological treatment. Recruiting --> Active, not recruiting
  • ||||||||||  THIO / MAIA Biotech
    Enrollment closed, Trial completion date, Trial primary completion date, IO biomarker:  THIO-101: THIO Sequenced with Cemiplimab in Advanced NSCLC (clinicaltrials.gov) -  Nov 21, 2024   
    P2,  N=182, Active, not recruiting, 
    Suspended --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025 Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Oct 2026 | Trial primary completion date: Jun 2024 --> Aug 2025
  • ||||||||||  REGN6569 / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment closed, Enrollment change, Trial completion date:  Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Nov 19, 2024   
    P1,  N=38, Active, not recruiting, 
    Due to the low number of patients, it is difficult to conclude for those over 75. Recruiting --> Active, not recruiting | N=85 --> 38 | Trial completion date: Jun 2026 --> Sep 2025
  • ||||||||||  Review, Journal, Checkpoint inhibition:  Immune Checkpoint Inhibitor Myopathy: The Double-Edged Sword of Cancer Immunotherapy. (Pubmed Central) -  Nov 15, 2024   
    Despite clinical improvements with immunomodulatory therapy, with corticosteroids the mainstay of treatment, mortality remains high, particularly in those with associated myocarditis or respiratory failure requiring intubation, where mortality occurs in up to 50%. ICI withdrawal can lead to cancer progression and death, highlighting a need for improved approaches to ICI rechallenge, performed in limited patients with variable success to date.
  • ||||||||||  An Evaluation of Non-Randomized Evidence (NRE) Used in HTA Decision-Making: A Case Study Review () -  Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2318;    
    These case studies illustrate that NRE can be a critical component in HTA and regulatory decision-making, particularly when RCTs are not feasible. NRE can provide robust evidence to support the efficacy and safety of treatments, facilitating access to innovative therapies for patients with high unmet medical needs.