- |||||||||| Sarclisa (isatuximab-irfc) / Sanofi
Trial completion date, Trial primary completion date: A Study of Isatuximab-based Therapy in Participants With Lymphoma (clinicaltrials.gov) - Aug 18, 2021 P1/2, N=130, Active, not recruiting, Trial completion date: Dec 2022 --> May 2022 | Trial primary completion date: Dec 2022 --> Feb 2021
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] IS ANTI-PD1-INDUCED COLITIS A DISTINCT HISTOLOGICAL SUBTYPE? (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_4623; Anti-PD1-induced colitis is expressed by different patterns of injury which share distinct histological hallmarks harboring diagnostic value, while a novel subtype of “combined” microscopic/UC-like colitis was recognized. The histological alterations are indicative of mucosa barrier vulnerability after ICI treatment and its participation in the pathogenetic process.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] IS ANTI-PD1-INDUCED COLITIS A DISTINCT HISTOLOGICAL SUBTYPE? (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_2443; Anti-PD1-induced colitis is expressed by different patterns of injury which share distinct histological hallmarks harboring diagnostic value, while a novel subtype of “combined” microscopic/UC-like colitis was recognized. The histological alterations are indicative of mucosa barrier vulnerability after ICI treatment and its participation in the pathogenetic process.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] IS ANTI-PD1-INDUCED COLITIS A DISTINCT HISTOLOGICAL SUBTYPE? (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_612; Anti-PD1-induced colitis is expressed by different patterns of injury which share distinct histological hallmarks harboring diagnostic value, while a novel subtype of “combined” microscopic/UC-like colitis was recognized. The histological alterations are indicative of mucosa barrier vulnerability after ICI treatment and its participation in the pathogenetic process.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Uveitis Associated with Immune Checkpoint Inhibitors () - Jul 19, 2021 - Abstract #ASCRSASOA2021ASCRS_ASOA_381; Purpose To evaluate the overall prevalence of uveitis among patients treated at UCLA Health with immune checkpoint inhibitors (ICPIs) and to examine treatment and clinical courses of these patients.MethodsAll patients with subsequent eye examinations as identified by CPT codes (92002, 92004, 92012, 92014, 92015, 92020, 92225, and 92226) following initiation of ICPI (pembrolizumab, nivolumab, cemiplimab, atezolizumab, avelumab, durvalumab, and ipilimumab) until March 2020 at UCLA Health were reviewed...Two patients (2/8, 25%) required oral prednisone...Patients on ICPIs should report any ocular side effects and be monitored for uveitis in order to treat it promptly. Further multi-center studies on ICPI-associated uveitis treatment and outcomes would be beneficial.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: How can we manage the cardiac toxicity of immune checkpoint inhibitors? (Pubmed Central) - Jul 17, 2021 There is a growing need for a multidisciplinary approach of ICI-associated cardiotoxicity, involving oncologists, cardiologists, and immunologists. Prevention and effective management of ICIs cardiotoxicity starts with an in-depth screening and surveillance strategies of high-risk patients, in order to improve early detection and appropriate management in a personalized approach.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion, Trial completion date, Trial primary completion date: Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma (clinicaltrials.gov) - Jul 16, 2021 P1, N=17, Completed, Prevention and effective management of ICIs cardiotoxicity starts with an in-depth screening and surveillance strategies of high-risk patients, in order to improve early detection and appropriate management in a personalized approach. Active, not recruiting --> Completed | Trial completion date: Feb 2022 --> Jul 2021 | Trial primary completion date: Feb 2022 --> Jul 2021
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial suspension: 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) - Jul 12, 2021 P1, N=65, Suspended, Active, not recruiting --> Completed | Trial completion date: Feb 2022 --> Jul 2021 | Trial primary completion date: Feb 2022 --> Jul 2021 Recruiting --> Suspended
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Checkpoint inhibition: Opportunities for using In Silico-Based Extended Dosing Regimens for Monoclonal Antibody Immune Checkpoint Inhibitors. (Pubmed Central) - Jul 4, 2021 Based on patient-specific estimates for clearance, optimal alternative dosing strategies can be simulated in order to lower drug and cost burden yet maintain therapeutic levels, especially as the clearance of the drug decreases over time. This review will comprehensively discuss each of the FDA approved PD-1, PD-L1/2 and CTLA-4 inhibitors regarding their indications and current recommended dosing, with evidence supporting the investigation of these types of TDM strategies.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, P1 data, Clinical Trial,Phase I, Journal, Monotherapy: Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, as monotherapy in patients with pretreated non-small cell lung cancer (NSCLC): Data from the Phase 1 NSCLC expansion cohort. (Pubmed Central) - Jun 22, 2021 P1 However, further prospective studies using ICIs in this high-risk patient population are needed. Cemiplimab showed an acceptable safety profile and demonstrated antitumor activity in pretreated patients with NSCLC.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] The Ethics of International Research (Program Auditorium) - Jun 17, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_159; Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial...Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer(KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial...Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC...Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer. New England Journal of Medicine 2019;381:2020-31.
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