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NCT03656718 · ClinicalTrials.gov registry record · Phase 1
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 139
- Enrollment target
NCT03656718: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT03656718 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 139 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03656718, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 139 participants
- Enrollment target
Study 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).
Primary Outcome
Cmax is the maximum observed serum nivolumab concentration. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
Interventions
- BIOLOGICAL nivolumab
- DRUG rHuPH20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2024-09-12 |
| Phase | Phase 1 |
What the finished NCT03656718 record still lists
NCT03656718 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 2 interventions - of which nivolumab is the first listed.
NCT03656718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03656718 about?
NCT03656718 is a clinical study titled "A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)". 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)...
What is the current status of trial NCT03656718?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 139 participants. The study started on 2018-10-29. Estimated completion is 2024-09-12.
What interventions are being tested in trial NCT03656718?
The interventions under investigation include: nivolumab (BIOLOGICAL), rHuPH20 (DRUG).
Who is sponsoring clinical trial NCT03656718?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03656718's enrollment target sits among peer trials
139 418th of 2000 higher than 1,583 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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