- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical Trial,Phase I, Clinical Trial,Phase II, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. (Pubmed Central) - Aug 16, 2018 P1, P2 Conclusions Among patients with advanced cutaneous squamous-cell carcinoma, cemiplimab induced a response in approximately half the patients and was associated with adverse events that usually occur with immune checkpoint inhibitors. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov numbers, NCT02383212 and NCT02760498 .).
- |||||||||| Review, Journal, Checkpoint inhibition: Cervical cancer - State of the science: From angiogenesis blockade to checkpoint inhibition. (Pubmed Central) - Jul 3, 2018
Phase II studies using anti-PD-1 molecules, nivolumab and pembrolizumab are ongoing, and GOG 3016, the first phase III randomized trial of a checkpoint inhibitor (cemiplimab) in cervical cancer, recently activated. Important considerations in attempts to inhibit the inhibitors include pseudoprogression and post-progression survival, abscopal effects, and immune-related adverse events, including endocrinopathies.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: EMPOWER-Cervical 1: Study of Cemiplimab in Adults With Cervical Cancer (clinicaltrials.gov) - Apr 27, 2018 P3, N=436, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Feb 2023 --> Jun 2023 | Trial primary completion date: May 2020 --> Jan 2022
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment open: A Vaccine (VSV-hIFN?-NIS) with or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma (clinicaltrials.gov) - Feb 8, 2018 P1, N=6, Recruiting, Trial primary completion date: May 2021 --> Jul 2021 | Trial completion date: May 2021 --> Jul 2021 | Initiation date: Jan 2018 --> Jan 2018 Active, not recruiting --> Recruiting
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed, Enrollment change: A Vaccine (VSV-hIFN?-NIS) with or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma (clinicaltrials.gov) - Jan 8, 2018 P1, N=6, Active, not recruiting, Trial primary completion date: Jul 2020 --> Jul 2019 Suspended --> Active, not recruiting | N=24 --> 6
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