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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 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 139 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03656718
The ClinicalTrials.gov registry entry for NCT03656718 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which nivolumab is the first listed.
NCT03656718 reports 0 study locations.
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.
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