NCT03656718CompletedPhase 1/2
Study of subcutaneous nivolumab monotherapy with or without Recombinant Human Hyaluronidase PH20 (rHuPH20)
CA209-8KX Phase I/II pharmacokinetic multi-tumor study of subcutaneous formulation of nivolumab monotherapy
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Jul 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 23 May 2023
- Start date
- 9 Jan 2019
- Lead sponsor
- Bristol Myers Squibb International Corporation
- Diseases
- Kidney cancer, Bladder cancer, Melanoma, Lung cancer, Colorectal cancer, Liver and biliary tract cancer
- NCT number
- NCT03656718
- EU CT number
- 2023-503554-12-00
- EudraCT number
- 2018-001585-42
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 96
- 9 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active, known, or suspected autoimmune disease
Other
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Maastricht University Coordinator of this site? Confirm its status | Maastricht | Netherlands | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.