Yervoy

Drug

Drug Profile

Yervoy (ipilimumab) is a CTLA-4-blocking monoclonal antibody immunotherapy used across multiple advanced malignancies, both as monotherapy and in combination regimens (commonly with nivolumab). Its U.S. oncology indications include melanoma, renal cell carcinoma combinations, MSI-H/dMMR metastatic colorectal cancer combinations, hepatocellular carcinoma combinations, NSCLC combinations, mesothelioma combinations, and selected esophageal cancer settings. U.S. initial approval was in 2011.

Drug Class
Human CTLA-4-blocking monoclonal antibody
Approval Status
FDA approved (Initial U.S. Approval: 2011; label updated through 2025)
Mechanism of Action
Immune checkpoint blockade of CTLA-4 pathway to enhance antitumor T-cell responses.
Brand Names
  • YERVOY
Indications
  • \Unresectable or metastatic melanoma in adults and pediatric patients 12 years and older (single-agent or with nivolumab)\
  • \Intermediate/poor risk advanced renal cell carcinoma in combination with nivolumab\
  • \MSI-H or dMMR metastatic colorectal cancer in combination with nivolumab after prior chemotherapy\
  • \First-line unresectable or metastatic hepatocellular carcinoma in combination with nivolumab\
  • \Multiple first-line metastatic/recurrent NSCLC combination regimens with nivolumab +/- platinum-doublet chemotherapy\
  • \Unresectable malignant pleural mesothelioma first-line combination with nivolumab\
  • \Unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma in combination with nivolumab\

Related News

Related Clinical Trials

NCT ID Title Status Phase
NCT07176650

Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma

RECRUITING PHASE1
NCT05004025

Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma

COMPLETED PHASE1
NCT03029780

An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

COMPLETED PHASE2
NCT02854488

Yervoy Pregnancy Surveillance Study

WITHDRAWN
NCT01496807

Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma

COMPLETED PHASE1