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


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  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Aphexda (motixafortide) / BioLineRx, Ayrmid
    Trial completion date, Trial primary completion date, Checkpoint inhibition:  Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma (clinicaltrials.gov) -  Mar 11, 2025   
    P2,  N=10, Recruiting, 
    This phase II trial is registered at www.clinicaltrials.gov as #NCT04763616. Trial completion date: Aug 2025 --> Aug 2028 | Trial primary completion date: Jul 2025 --> Jun 2028
  • ||||||||||  Review, Journal, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker:  Angiosarcoma: Role of Immunotherapy. (Pubmed Central) -  Mar 9, 2025   
    Trial completion date: Aug 2025 --> Aug 2028 | Trial primary completion date: Jul 2025 --> Jun 2028 Single-agent ICI therapy, such as cemiplimab (ORR 27.8%), has shown responses primarily in UV- and radiation-associated angiosarcomas, likely due to their higher tumor mutation burden (TMB), while dual ICI therapy (SWOG S1609, ORR 25%) suggests potential benefit but remains limited in cutaneous disease...The Alliance A091902 first-line trial (paclitaxel?
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / BMS
    Review, Journal, Checkpoint inhibition, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker:  Immune checkpoint inhibitors for children with xeroderma pigmentosum and advanced cutaneous squamous cell carcinoma: A case presentation and brief review. (Pubmed Central) -  Mar 7, 2025   
    Following a tumor board recommendation, systemic immunotherapy with cemiplimab was initiated...Incidence and nature of adverse events in XP patients were comparable to those observed in the general population. In line with the previously reported ICI-treated XP children, the present case confirms that anti-PD-1 inhibitors are highly effective in children with XP and advanced cSCC.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment open:  Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC (clinicaltrials.gov) -  Mar 7, 2025   
    P2,  N=112, Recruiting, 
    In line with the previously reported ICI-treated XP children, the present case confirms that anti-PD-1 inhibitors are highly effective in children with XP and advanced cSCC. Not yet recruiting --> Recruiting
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Praluent (alirocumab) / Sanofi, Regeneron
    Trial completion date, Trial primary completion date:  TOP 2301: Neoadjuvant Chemo for NSCLC (clinicaltrials.gov) -  Mar 5, 2025   
    P2,  N=126, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Aug 2028 --> Oct 2029 | Trial primary completion date: Aug 2026 --> Oct 2027
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Journal:  Immunotherapy for orbital squamous cell carcinoma. (Pubmed Central) -  Feb 27, 2025   
    Two (66%) patients that had tissue analysis following immunotherapy showed complete pathologic response. Our findings support the emerging role of immunotherapy in the management of invasive orbital squamous cell carcinoma.
  • ||||||||||  REGN6569 / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion date, Trial termination:  Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Feb 24, 2025   
    P1,  N=38, Terminated, 
    Our findings support the emerging role of immunotherapy in the management of invasive orbital squamous cell carcinoma. Trial completion date: Sep 2025 --> Feb 2025 | Active, not recruiting --> Terminated; Sponsor Decision
  • ||||||||||  Herceptin (trastuzumab) / Roche
    Trastuzumab: a potential therapy for unresectable Stage IV cutaneous squamous cell carcinoma () -  Feb 21, 2025 - Abstract #AAD2025AAD_2409;    
    Identification of riskier causative agents may aid in treatment selection, especially in patients with previous history of AIBD or genetic susceptibility. Cutaneous squamous cell carcinomas (SCC) are common cutaneous cancers with excellent prognosis.1 3-5% of SCCs develop metastasis which are often complicated by poor therapeutic response and recurrence.1,2 Epidermal growth factor receptors, HER2, HER3, and HER4, have been implicated in SCCs, however, its therapeutic potential have yet to be delineated.3
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial initiation date:  Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer (clinicaltrials.gov) -  Feb 21, 2025   
    P3,  N=420, Recruiting, 
    Cutaneous squamous cell carcinomas (SCC) are common cutaneous cancers with excellent prognosis.1 3-5% of SCCs develop metastasis which are often complicated by poor therapeutic response and recurrence.1,2 Epidermal growth factor receptors, HER2, HER3, and HER4, have been implicated in SCCs, however, its therapeutic potential have yet to be delineated.3 Initiation date: Sep 2025 --> Feb 2025
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Review, Journal:  Recent advances in immunotherapy for cervical cancer. (Pubmed Central) -  Feb 20, 2025   
    Clinical trials involving immune checkpoint inhibitors are now being conducted following a phase 3 trial with cemiplimab, an ICI, which demonstrated a significant improvement in prognosis in advanced or metastatic cervical cancer patients...Ongoing trials will continue to illuminate the optimal strategies for combining these therapies and addressing challenges associated with immune checkpoint failure in cervical cancer. Herein, we conducted a review of articles related to immunotherapy for cervical cancer and describe current treatment strategies for cervical cancer via immunotherapy.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Journal:  Severe hypersensitivity reactions to 2 immunotherapy agents in a patient with cutaneous squamous cell carcinoma. (Pubmed Central) -  Feb 20, 2025   
    Herein, we conducted a review of articles related to immunotherapy for cervical cancer and describe current treatment strategies for cervical cancer via immunotherapy. A patient with metastatic cutaneous squamous cell carcinoma developed a severe hypersensitivity reaction to pembrolizumab and subsequently to cemiplimab, despite premedication.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
    Enrollment open, Trial completion date, Trial primary completion date:  A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) -  Feb 12, 2025   
    P2,  N=10, Recruiting, 
    N=74 --> 23 | Trial completion date: Jun 2025 --> Jun 2027 | Trial primary completion date: Jun 2024 --> Jun 2026 Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Feb 2028 | Trial primary completion date: Dec 2026 --> Feb 2028
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment closed, Trial completion date, Trial primary completion date:  Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer (clinicaltrials.gov) -  Feb 11, 2025   
    P2,  N=36, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Feb 2028 | Trial primary completion date: Dec 2026 --> Feb 2028 Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Aug 2025 | Trial primary completion date: Jan 2025 --> Jul 2025
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Journal:  CASE (CemiplimAb-rwlc Survivorship and Epidemiology): a study in advanced basal cell carcinoma. (Pubmed Central) -  Feb 6, 2025   
    P=N/A
    Outcome measures of the study include response to treatment, quality of life, safety, treatment patterns, patient experience, and survival. This study could provide a more complete characterization of this patient population and fill knowledge gaps related to real-world treatment utilization and patient outcomes.Clinical Trial registration: NCT03836105.
  • ||||||||||  Retrospective data, Review, Journal, Adverse events, Checkpoint inhibition:  Cardiotoxicity associated with immune checkpoint inhibitors: Systematic Review and Meta-analysis. (Pubmed Central) -  Feb 5, 2025   
    This study proved that the recognition of frequency and severity of all grade cardiotoxicity associated with ICIs is still underestimated. Thus, a systematic cardiological screening becomes necessary, in order to intercept the potential cardiological complications beforehand and optimize the outcomes of the respective treatment with PD-1, PD-L1 and CTLA-4 inhibitors.
  • ||||||||||  HST-1011 / HotSpot Therap
    Enrollment closed, Enrollment change, Monotherapy:  SOLAR1: A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody (clinicaltrials.gov) -  Feb 4, 2025   
    P1/2,  N=77, Active, not recruiting, 
    Thus, a systematic cardiological screening becomes necessary, in order to intercept the potential cardiological complications beforehand and optimize the outcomes of the respective treatment with PD-1, PD-L1 and CTLA-4 inhibitors. Recruiting --> Active, not recruiting | N=203 --> 77
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion date:  CONTRAC: Cemiplimab in AlloSCT/SOT Recipients With CSCC (clinicaltrials.gov) -  Feb 4, 2025   
    P1/2,  N=12, Active, not recruiting, 
    Conclusion Our findings provide a reference for healthcare providers to predict irAE characteristics induced by ICIs in patients, thereby facilitating effective cancer treatment. Trial completion date: Jan 2025 --> Jan 2026
  • ||||||||||  tuvusertib (M1774) / EMD Serono
    Trial completion date, Trial primary completion date:  Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322) (clinicaltrials.gov) -  Jan 28, 2025   
    P1/2,  N=61, Active, not recruiting, 
    These results support the use of second-line cemiplimab for patients with recurrent cervical cancer. Trial completion date: Mar 2025 --> Feb 2026 | Trial primary completion date: Jun 2024 --> May 2025
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment open, Trial completion date, Trial primary completion date:  Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) -  Jan 22, 2025   
    P3,  N=369, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Trial completion date: Jun 2029 --> May 2030 | Trial primary completion date: Jun 2029 --> May 2030