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NCT04752826 · ClinicalTrials.gov registry record · Phase 1
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
A Phase 1 study of Ovarian Cancer and Melanoma, sponsored by BioInvent International AB.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 176
- Enrollment target
- 20
- Study locations
NCT04752826: Recruiting Phase 1 study of Ovarian Cancer and Melanoma, sponsored by BioInvent International AB.
NCT04752826 is a Phase 1 study of Ovarian Cancer and Melanoma that is actively recruiting participants, run by BioInvent International AB. The registered enrollment target is 176 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04752826, a Phase 1 study of Ovarian Cancer and Melanoma, is actively recruiting participants, sponsored by BioInvent International AB.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 176 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy. The main questions it aims to answer are: * how safe and tolerable is BI-1808 * what is maximum tolerated or administrated dose * to determine recommended dose for further clinical trials. Participants will receive infusions of BI-1808 alone or combination with pembrolizumab every 3 weeks. For the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors and subjects with T-cell lymphoma (TCL),
Primary Outcome
AEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between AEs and the exposure to the study treatment.
Conditions Studied
Interventions
- DRUG BI-1808
- DRUG Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection
Study Locations (20)
Other
- Rigshospitalet - Copenhagen
- Herlev Hospital - Herlev
- PRA Health Sciences - Hungary - Budapest
- Magyar Honvédség-Egészségügyi Központ - Budapest
- Debreceni Egyetem Klinikai Központ - Debrecen
- Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser - Omsk
- National Medical Research Center VA Almazov - Saint Petersburg
- N.N. Petrov National Medical Research Center of Oncology - Saint Petersburg
- Institut Catala d'oncologia. Hospital Duran I Reynals - Barcelona
- Hospital General Universitario Gregorio Marañon - Madrid
- START Madrid - Hospital Universitario Fundación Jiménez Díaz - Madrid
- Hospital Universitario 12 de Octubre - Madrid
- Sahlgrenska University Hospital - Gothenburg
- Skanes University Hospital - Lund
- Karolinska University Hospital, Solna - Stockholm
- University Hospital Birmingham - Birmingham
- University Hospitals of Leicester NHS Trust - Leicester
California
- City of Hope National Medical Center - Duarte
New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2028-01-15 |
| Phase | Phase 1 |
What NCT04752826 shows while recruiting
NCT04752826 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (76% lower).
The record links to 4 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which BI-1808 is the first listed.
NCT04752826 names 20 study sites across 4 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT04752826 about?
NCT04752826 is a clinical study titled "BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)". The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy. The main questions it aims to answer are: * how safe and tolerable is BI-...
What is the current status of trial NCT04752826?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 176 participants. The study started on 2021-01-25. Estimated completion is 2028-01-15.
What conditions does trial NCT04752826 study?
This clinical trial studies the following conditions: Ovarian Cancer, Melanoma, T-Cell Lymphoma, Advanced Malignancies.
What interventions are being tested in trial NCT04752826?
The interventions under investigation include: BI-1808 (DRUG), Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection (DRUG).
Who is sponsoring clinical trial NCT04752826?
This trial is sponsored by BioInvent International AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04752826 being conducted?
This trial has 20 study locations across California, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04752826's enrollment target sits among peer trials
176 107th of 322 higher than 214 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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.
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