Trials / Completed
CompletedNCT03656718
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 139 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | nivolumab | (Subcutaneous) Specified dose on specified days |
| DRUG | rHuPH20 | Specified dose on specified days Permeation enhancer |
| BIOLOGICAL | nivolumab | (IV) Specified Dose on Specified Days |
Timeline
- Start date
- 2018-10-29
- Primary completion
- 2022-09-07
- Completion
- 2024-09-12
- First posted
- 2018-09-04
- Last updated
- 2025-11-12
- Results posted
- 2025-02-20
Locations
36 sites across 12 countries: United States, Argentina, Brazil, Chile, France, Italy, Mexico, Netherlands, New Zealand, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03656718. Inclusion in this directory is not an endorsement.