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Study of subcutaneous nivolumab monotherapy with or without Recombinant Human Hyaluronidase PH20 (rHuPH20)
EU CTIS ID: 2023-503554-12-00
What this study is testing
Parts A- D: To describe the pharmacokinetics of nivolumab administered subcutaneously, with or without rHuPH20 Part E: To evaluate the pharmacokinetics of SC nivolumab 600 mg Q2W coformulated with rHuPH20
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types: 1) Metastatic squamous or non-squamous NSCLC 2) Renal Cell Carcinoma, advanced or metastatic 3) Melanoma 4) Hepatocellular Carcinoma 5) Colorectal Cancer, metastatic (MSI-H or dMMR) 6) Urothelial carcinoma , metastatic(part E only)
- - Measurable disease as per RECIST version 1.1 criteria
- - ECOG performance status of 0 or 1
You likely can't join if
- - Active brain metastases or leptomeningeal metastases
- - Ocular melanoma
- - Active, known, or suspected autoimmune disease
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Chile
- Brazil
- United Kingdom
- Argentina
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Chile; Brazil; United Kingdom; Argentina; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.