A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Public ClinicalTrials.gov record NCT03656718. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03656718
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 139 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 28, 2018
- Primary completion
- Sep 6, 2022
- Completion
- Sep 11, 2024
- Last update posted
- Nov 11, 2025
2018 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Winship Cancer Institute. | Atlanta | Georgia | 30322 | — |
| Local Institution - 0024 | Rockville | Maryland | 20850 | — |
| Local Institution - 0020 | Detroit | Michigan | 48201-2014 | — |
| Local Institution - 0001 | Charlotte | North Carolina | 28204 | — |
| Local Institution - 0012 | Eugene | Oregon | 97401 | — |
| Greenville Health System | Greenville | South Carolina | 29605 | — |
| Local Institution - 0010 | Austin | Texas | 78705 | — |
| Local Institution - 0009 | Beaumont | Texas | 77702-1449 | — |
| Local Institution - 0007 | Dallas | Texas | 75246 | — |
| Local Institution - 0011 | Tyler | Texas | 75702 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03656718, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 11, 2025 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03656718 live on ClinicalTrials.gov.