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NCT04551352 · ClinicalTrials.gov registry record · Phase 1
A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas
A Phase 1 study of Cutaneous Melanoma and Uveal Melanoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 14
- Study locations
NCT04551352: Completed Phase 1 study of Cutaneous Melanoma and Uveal Melanoma, sponsored by Hoffmann-La Roche.
NCT04551352 is a Phase 1 study of Cutaneous Melanoma and Uveal Melanoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 20 participants, below the 366-participant average among 30 other Cutaneous Melanoma trials with a reported enrollment target (95% lower). The trial reports 14 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04551352, a Phase 1 study of Cutaneous Melanoma and Uveal Melanoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a first-in-human, multi-center clinical study to determine the safety, Maximum Tolerated Dose (MTD) and/or Optimal Biological Dose (OBD) as well as the optimal schedule for intravenous (IV) and/or subcutaneous (SC) administrations of RO7293583 with or without obinutuzumab pretreatment, in participants with unresectable metastatic TYRP1-positive melanomas who have progressed on standard of care (SOC) treatment, are intolerant to SOC, or are non-amenable to SOC. This study will include an initial single participant dose-escalation part one followed by a multiple participant dose-escalation part two with the possibility of expansion.
Primary Outcome
Dose-Limiting Toxicities (DLTs) were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), except for Cytokine release syndrome (CRS), which will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Adalimumab
- DRUG Tocilizumab
- DRUG RO7293583
Study Locations (14)
Other
- UZ Antwerpen - Edegem
- UZ Leuven Gasthuisberg - Leuven
- Herlev Hospital; Afdeling for Kræftbehandling - Herlev
- Vall d´Hebron Institute of Oncology (VHIO), Barcelona - Barcelona
- Clinica Universidad de Navarra Madrid; Servicio de Oncología - Madrid
- Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia - Valencia
Ontario
- The Ottawa Hospital - General Campus - Ottawa
- Princess Margaret Cancer Center - Toronto
Massachusetts
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan-Kettering Cancer Center - New York
Pennsylvania
- Thomas Jefferson University Hospital;Medical Oncology - Philadelphia
Tennessee
- Sarah Cannon Research Institute - Nashville
Victoria
- Peter Maccallum Cancer Institute; Clinical Trial Unit - Melbourne
Navarre
- Clinica Universitaria de Navarra - Pamplona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-10-28 |
| Est. Completion | 2022-07-28 |
| Phase | Phase 1 |
What the finished NCT04551352 record still lists
NCT04551352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 366-participant average among 30 other Cutaneous Melanoma trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Cutaneous Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Obinutuzumab is the first listed.
NCT04551352 lists 14 locations in 8 states (Other, Ontario, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04551352 about?
NCT04551352 is a clinical study titled "A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas". This is a first-in-human, multi-center clinical study to determine the safety, Maximum Tolerated Dose (MTD) and/or Optimal Biological Dose (OBD) as well as the optimal schedule for intravenous (IV) and/or subcutaneous (SC) administrations of RO7293583 with or without obinutuzumab pretreatment, in pa...
What is the current status of trial NCT04551352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-10-28. Estimated completion is 2022-07-28.
What conditions does trial NCT04551352 study?
This clinical trial studies the following conditions: Cutaneous Melanoma, Uveal Melanoma, Mucosal Melanoma.
What interventions are being tested in trial NCT04551352?
The interventions under investigation include: Obinutuzumab (DRUG), Adalimumab (DRUG), Tocilizumab (DRUG), RO7293583 (DRUG).
Who is sponsoring clinical trial NCT04551352?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04551352 being conducted?
This trial has 14 study locations across Massachusetts, New York, Pennsylvania, Tennessee, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04551352's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cutaneous Melanoma 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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