ipilimumab subcutaneous (BMS-734016 SC) / Ono Pharma, BMS - LARVOL DELTA

ASCO GU 2025: Optimizing Treatment Selection and Clinical Decision-Making in Advanced RCC : Episode 1: Long-Term Outcomes in Advanced RCC: Analyzing 8 Years of CheckMate 214 Data (OncLive) - "Experts discuss the 8-year follow-up data from the CheckMate 214 trial evaluating nivolumab plus ipilimumab for first-line treatment of advanced renal cell carcinoma (RCC), and how these mature overall survival (OS) data influence the view of nivolumab plus ipilimumab as a frontline option, alongside insights from efficacy, safety, post hoc subgroup analyses (Albiges et al, Eur Urol, 2022), and health-related quality of life (HRQOL) data (Cella et al, J Clin Oncol, 2022)."

Video • Renal Cell Carcinoma

ASCO 2024: Updates in the Treatment of Advanced Renal Cell Carcinoma : Episode 2: Dr Wulff-Burchfield Reviews CheckMate 214 and CheckMate 9ER (OncLive) - The panelists examine the latest findings from the CheckMate 214 trial, which assessed the combination of nivolumab and ipilimumab (nivo + ipi) as a first-line treatment for advanced renal cell carcinoma, focusing on efficacy, safety, and quality of life outcomes.

Video

Shailender Bhatia, MD, on Merkel Cell Carcinoma: Results From CheckMate 358 on Nivolumab With or Without Ipilimumab (THE ASCO POST) - "Shailender Bhatia, MD...discusses phase I/II results on the efficacy of nivolumab with or without ipilimumab in patients with recurrent or metastatic Merkel cell carcinoma. The study found that, for this rare and aggressive skin cancer, nivolumab showed clinical activity in advanced disease. However, these results from CheckMate 358 do not suggest an additional benefit with ipilimumab added to nivolumab (Abstract 9506)."

Video

CheckMate 76U: A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types (clinicaltrials.gov) - P1/2 | N=21 | Terminated | Sponsor: Bristol-Myers Squibb | Trial completion date: Apr 2023 ➔ Jan 2023 | Active, not recruiting ➔ Terminated; Business objectives have changed

Combination therapy • Monotherapy • Pan tumor • Trial completion date • Trial termination • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study of a Personalized Neoantigen Cancer Vaccine (clinicaltrials.gov) - P1/2 | N=29 | Completed | Sponsor: Gritstone bio, Inc. | Active, not recruiting ➔ Completed | N=214 ➔ 29 | Trial completion date: Mar 2023 ➔ Nov 2022 | Trial primary completion date: Jul 2022 ➔ Nov 2022

Checkpoint block • Checkpoint inhibition • Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

Gritstone Announces Dosing of First Solid Tumor Patient with Optimized SLATE “Off-the-Shelf” Mutant KRAS-directed Neoantigen Immunotherapy in Phase 2 Clinical Trial (GlobeNewswire) - P1/2, N=144; NCT03953235; Sponsor: Gritstone Oncology, Inc; “SLATE v1 exhibited evidence of efficacy in patients with NSCLC who had all progressed on prior anti-PD-(L)1 therapy (often in combination with chemotherapy) – with molecular responses (>50% decrease in ctDNA levels in the blood from baseline) observed in 3/5 NSCLC patients who were eligible for analysis. SLATE v1 demonstrated the greatest activity in 6 NSCLC patients with the KRASmut G12C presented by the HLA protein A*02:01. Among these patients, ctDNA responses were observed in 66% of these patients (2/3 eligible for analysis), correlating with clinical benefit, and a RECIST radiologic response (unconfirmed) was observed in one 2nd line patient who had progressed after 3 months of 1st line chemo-immunotherapy. One patient who had progressed on prior chemo-immunotherapy after 8 months of treatment is nearing completion of 2 years of therapy with persistent ~20% tumor lesion shrinkage."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A Study of a Personalized Neoantigen Cancer Vaccine (clinicaltrials.gov) - P1/2; N=214; Active, not recruiting; Sponsor: Gritstone Oncology, Inc.; Recruiting ➔ Active, not recruiting

Checkpoint inhibition • Clinical • Combination therapy • Enrollment closed • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

Two nivolumab regimens outperform chemotherapy alone in advanced esophageal cancer (Healio) - P3, N=970; CheckMate 648 (NCT03143153); Sponsor: Bristol-Myers Squibb; "Results showed significantly longer median OS with nivolumab plus chemotherapy vs. chemotherapy alone (15.4 months vs. 9.1 months; HR = 0.54; 99.5% CI, 0.37-0.8) and with nivolumab plus ipilimumab vs. chemotherapy alone (13.7 months vs. 9.1 months; HR = 0.64; 98.6% CI, 0.46-0.9) among patients with PD-L1 expression of 1% or greater....Julie Gralow, MD: The CheckMate 648 study found two regimens that improved OS beyond the current standard of care....he dual immunotherapy combination is the first chemotherapy-free first-line treatment showing benefit for these patients."

Checkpoint inhibition • Media quote • P3 data

CheckMate 76U: A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types (clinicaltrials.gov) - P1/2; N=21; Active, not recruiting; Sponsor: Bristol-Myers Squibb; Recruiting ➔ Active, not recruiting; N=81 ➔ 21; Trial completion date: Oct 2025 ➔ Apr 2023; Trial primary completion date: Mar 2024 ➔ Jan 2021

Combination therapy • Enrollment change • Enrollment closed • Monotherapy • Pan tumor • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma

CheckMate 76U: A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types (clinicaltrials.gov) - P1/2; N=81; Recruiting; Sponsor: Bristol-Myers Squibb; Not yet recruiting ➔ Recruiting; Trial completion date: Jul 2023 ➔ Oct 2025; Trial primary completion date: Jul 2023 ➔ Mar 2024

Combination therapy • Enrollment open • Monotherapy • Pan Tumor • Trial completion date • Trial primary completion date • Bladder Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Thoracic Cancer