- |||||||||| ISA101 / ISA Pharma
Enrollment closed, Trial primary completion date: OpcemISA: A Randomized Phase 2 Study of Cemiplimab (clinicaltrials.gov) - Feb 8, 2023 P2, N=194, Active, not recruiting, Trial completion date: Mar 2024 --> Jan 2025 | Trial primary completion date: Mar 2023 --> Jan 2024 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2022 --> Sep 2023
- |||||||||| Libtayo (cemiplimab) / Regeneron
Clinical parameters associated with immunotherapy outcomes in metastatic cutaneous SCC () - Feb 8, 2023 - Abstract #ECHNOICHNO2023ECHNO_ICHNO_254; Conclusion Cemiplimab treatment demonstrated significant clinical benefit with a manageable side effect profile. Patients with R/M-cSCC with a head and neck primary site have a significantly improved OS and PFS compared with other primary sites when treated with cemiplimab, and future work should be undertaken to investigate this further.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Trial completion date, Trial primary completion date: A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab (clinicaltrials.gov) - Feb 3, 2023 P1, N=44, Recruiting, Patients with R/M-cSCC with a head and neck primary site have a significantly improved OS and PFS compared with other primary sites when treated with cemiplimab, and future work should be undertaken to investigate this further. Not yet recruiting --> Recruiting | Trial completion date: May 2026 --> Sep 2026 | Trial primary completion date: May 2026 --> Sep 2026
- |||||||||| vusolimogene oderparepvec (RP1) / Replimune
Enrollment closed, Trial completion date, Trial primary completion date: CERPASS: Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer (clinicaltrials.gov) - Feb 3, 2023 P2, N=231, Active, not recruiting, Not yet recruiting --> Recruiting | Trial completion date: May 2026 --> Sep 2026 | Trial primary completion date: May 2026 --> Sep 2026 Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Dec 2022 --> Sep 2025
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Praluent (alirocumab) / Sanofi, Regeneron
Trial completion date, Trial initiation date, Trial primary completion date: PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung (clinicaltrials.gov) - Feb 1, 2023 P2, N=25, Not yet recruiting, Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Dec 2022 --> Sep 2025 Trial completion date: Oct 2028 --> Jan 2029 | Initiation date: Jan 2023 --> Apr 2023 | Trial primary completion date: Oct 2026 --> Jan 2027
- |||||||||| ASP8374 / Astellas
Trial completion date: ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - Jan 17, 2023 P1, N=14, Active, not recruiting, Concomitant therapy permitted to obtain an earlier radiological response, a beneficial local therapeutic effect of radiotherapy, without any safety alert. Trial completion date: Dec 2022 --> Dec 2024
- |||||||||| Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab) / Regeneron
Journal: Management of basal cell carcinoma with pulmonary metastasis. (Pubmed Central) - Jan 5, 2023 CT reports were initially consistent with response but after 6 months of cemiplimab treatment, repeat CT chest scans revealed a decrease in size of the previously cited pulmonary lesions.This is a rare case of BCC metastases which has limited treatment options. This case provides insight of the patient experience on such treatment.
- |||||||||| FDA event, Journal, Checkpoint inhibition: Patterns of toxicity burden for FDA-approved immune checkpoint inhibitors in the United States. (Pubmed Central) - Jan 5, 2023
There are risks of respiratory and urinary system toxicity in male patients and reproductive system toxicity in female patients treated with the ICIs studied. Future studies on the toxicity burden of ICIs should incorporate age and sex differences to better understand the relevance of ICI toxicity burden to human immune function to develop appropriate tumor immune and therapeutic intervention strategies.
- |||||||||| Libtayo (cemiplimab) / Regeneron
Journal: The current clinical approach to difficult-to-treat basal cell carcinomas. (Pubmed Central) - Dec 30, 2022 The immune checkpoint inhibitor cemiplimab has been approved for the treatment of locally advanced or metastatic BCC refractory to HHI therapy or in patients intolerant to HHI therapy. Multidisciplinary teams (MDTs) play a key role in managing these complex patients.
|