A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Summary

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: * non-small cell lung cancer (NSCLC) * renal cell carcinoma (RCC) * unresectable or metastatic melanoma * hepatocellular carcinoma (HCC) * microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC) * in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician * In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

Timeline

Start

2018-10-29

Primary completion

2022-09-07

Completion

2024-09-12

Publications

• Lonardi S, Lugowska I, O'Donnell A, Jackson C, Latten-Jansen LM, North R, Bahleda R, Garrido M, Santoro A, Chacon MR, Li L, Joseph D, Vezina HE, Aras U, Bennett B, Perumal D, Gurm B, Ng WT, Harvey RD, Trigo J, Calvo A. Pharmacokinetics and safety of subcutaneous nivolumab: results from the phase I/II CheckMate 8KX study. J Immunother Cancer. 2025 Oct 5;13(10):e011918. doi: 10.1136/jitc-2025-011918.

Drugs

Indications