- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Yervoy (ipilimumab) / Ono Pharma, BMS
Immune Checkpoint Inhibitors: Effects on Thyroid Nodular Disease (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_627; As described, there was a significant change in size and a previously biopsied isthmus nodule was not seen on her last ultrasound. Although irAEs are well established, there is limited literature regarding changes in anatomy and thyroid nodule architecture.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Combination therapy, Metastases: Exposure-response analysis for nivolumab plus ipilimumab combination therapy in patients with advanced hepatocellular carcinoma (CheckMate 040). (Pubmed Central) - May 11, 2023 Objective tumor response (OTR) and overall survival (OS) improvements were associated with increased ipilimumab exposure (OTR: odds ratio 1.45 [95% CI, 1.13-1.86]; OS: hazard ratio 0.86 [0.75-0.98]), but not nivolumab exposure (OTR: odds ratio 0.99 [0.97-1.02]; OS: hazard ratio 1.08 [0.89-1.32]). Hepatic treatment-related and immune-mediated adverse events were more common in arm A than in arms B or C. Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg Q3W for four doses, followed by nivolumab monotherapy 240 mg Q2W had the most favorable benefit:risk profile in patients with advanced hepatocellular carcinoma.
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial suspension: EA2201: Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer (clinicaltrials.gov) - May 11, 2023 P2, N=31, Suspended, Hepatic treatment-related and immune-mediated adverse events were more common in arm A than in arms B or C. Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg Q3W for four doses, followed by nivolumab monotherapy 240 mg Q2W had the most favorable benefit:risk profile in patients with advanced hepatocellular carcinoma. Recruiting --> Suspended
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors. (Pubmed Central) - May 9, 2023 Among severe irAEs, the median interval between vaccination and ICI treatment closest to the occurrence of severe irAE was 15.5 days (IQR: 10.0-23.0). In solid tumor cancer subjects receiving ICIs, COVID-19 vaccination is not associated with an increased incidence of severe irAEs compared to historical data and may be safely administered during ICI cancer therapy in subjects who lack contraindications.
- |||||||||| TP-1454 / Sumitomo Pharma
Enrollment open, Trial completion date, Trial primary completion date: Phase 1 Study of Oral TP-1454 (clinicaltrials.gov) - May 9, 2023 P1, N=50, Recruiting, In solid tumor cancer subjects receiving ICIs, COVID-19 vaccination is not associated with an increased incidence of severe irAEs compared to historical data and may be safely administered during ICI cancer therapy in subjects who lack contraindications. Active, not recruiting --> Recruiting | Trial completion date: Oct 2023 --> Dec 2025 | Trial primary completion date: Apr 2023 --> Sep 2025
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Metastases: The Latest Option: Nivolumab and Relatlimab in Advanced Melanoma. (Pubmed Central) - May 8, 2023 While the safety profile is more favorable than that of ipilimumab plus nivolumab, no significant survival benefit has yet been demonstrated with the new combination over nivolumab monotherapy. The approval of relatlimab plus nivolumab by both the Food and Drug Administration and the European Medicines Agency expands the arsenal of treatment options for melanoma but raises new questions in clinical practice and a re-evaluation of currently established treatment standards and sequences.
- |||||||||| Inlyta (axitinib) / Pfizer, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment open: AxIn: Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients (clinicaltrials.gov) - May 8, 2023 P2, N=118, Recruiting, The approval of relatlimab plus nivolumab by both the Food and Drug Administration and the European Medicines Agency expands the arsenal of treatment options for melanoma but raises new questions in clinical practice and a re-evaluation of currently established treatment standards and sequences. Not yet recruiting --> Recruiting
- |||||||||| Yervoy (ipilimumab) / Ono Pharma, BMS
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: NeAT Glio: A Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - May 6, 2023 P2, N=1, Terminated, Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Feb 2023 --> Nov 2023 N=43 --> 1 | Trial completion date: Aug 2025 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Aug 2023 --> May 2023; Support withdrawn from drug company supplying IMP
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed, Enrollment change: Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors (clinicaltrials.gov) - May 6, 2023 P2, N=9, Active, not recruiting, N=43 --> 1 | Trial completion date: Aug 2025 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Aug 2023 --> May 2023; Support withdrawn from drug company supplying IMP Recruiting --> Active, not recruiting | N=21 --> 9
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Real-world experience of immune checkpoint inhibitors in MSI-H/dMMR metastatic colorectal cancer in a tertiary cancer center in Saudi Arabia (Poster HALL LEVEL 0) - May 6, 2023 - Abstract #ESMOGI2023ESMO_GI_533; Here, we described a real-world experience of immune checkpoint inhibitors in MSI-H/dMMR metastatic colorectal cancer in a Saudi tertiary cancer center. This is a retrospective cohort study where clinicopathologic data were collected from patients with MSI-H/dMMR metastatic colorectal cancer treated with at least one of the immune checkpoint inhibitors pembrolizumab, nivolumab and/or ipilimumab at the Ministry of National Guard
- |||||||||| Kaitanni (cadonilimab) / Akesobio
Efficacy and safety of cadonilimab combined with FLOT regimen as a neoadjuvant therapy for locally advanced gastric/gastroesophageal junction adenocarcinoma: A prospective, multicenter, open-label, single-arm phase II study (Poster HALL LEVEL 0) - May 6, 2023 - Abstract #ESMOGI2023ESMO_GI_401; NEONIPIGA trial proved that nivolumab and ipilimumab-based NAT in patients with dMMR/MSI-H resectable G/GEJ adenocarcinoma is feasible, and achieved a significant (pathological complete response) pCR rate over programmed cell death-1 (PD-1) antibody alone...Participants received 4 preoperative cycles of cadonilimab (10mg/kg, IV, q3w) plus FLOT (docetaxel 50mg/m2, oxaliplatin 85mg/m2, 5-FU 2600mg/m2, leucovorin 200mg/m2, IV, q3w) therapy, following a radical gastrectomy and 4 cycles of FLOT adjuvant chemotherapy every 3 weeks...Tumor Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), disease control rate (DCR), incidence of TRAEs and irAEs during preoperative and postoperative treatment period, R0 resection rate, postoperative complications and overall survival (OS) and progression-free survival (PFS).Clinical trial identification: Chictr.org.cn, ChiCTR2200066893.Editorial acknowledgement: This study was sponsored by Akeso Biopharma, Inc. Medical writing support/editorial support, under the direction of the authors, was provided by Yongkang Zhang and was funded by Akeso Biopharma, Inc.Legal entity responsible for the study: Akeso Biopharma, Inc.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
IMMUNORELATED RENAL ADVERSE EFFECTS IN PATIENTS TREATED WITH CHECKPOINT INHIBITORS. (Focussed Oral Room 5) - May 4, 2023 - Abstract #ERAEDTA2023ERA_EDTA_917; ICIs-related nervous toxicities require a multidisciplinary management, in which neurologists and clinical pharmacologists should participate. We retrospectively studied 28 patients (72.4% male, median age 71.1 years, IR: 40.1
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