Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)

Phase 2 Completed 81 enrolled Memorial Sloan Kettering Cancer Center Adaptive Biotechnologies · collab Bristol-Myers Squibb · collab MedGenome · collab UConn Health · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate the characteristics of tumors in patients treated with nivolumab and to identify features that help to predict a good or bad response to this drug.

Timeline

Start: 2015-09-14
Primary completion: 2024-04-29
Completion: 2024-04-29

Publications

Teo MY, Seier K, Ostrovnaya I, Regazzi AM, Kania BE, Moran MM, Cipolla CK, Bluth MJ, Chaim J, Al-Ahmadie H, Snyder A, Carlo MI, Solit DB, Berger MF, Funt S, Wolchok JD, Iyer G, Bajorin DF, Callahan MK, Rosenberg JE. Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit From PD-1/PD-L1 Blockade in Advanced Urothelial Cancers. J Clin Oncol. 2018 Jun 10;36(17):1685-1694. doi: 10.1200/JCO.2017.75.7740. Epub 2018 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	1 mg/kg	—
Subject	Nivolumab	Monoclonal antibody	240 mg	—
Subject	Nivolumab	Monoclonal antibody	480 mg	—
Background	Ipilimumab	Monoclonal antibody	3 mg/kg	—

Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)

Summary

Timeline

Publications

Drugs

Indications