Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas

NCT04551352 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 20 participants
Start Date 2020-10-28
Est. Completion 2022-07-28
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04551352

The ClinicalTrials.gov registry entry for NCT04551352 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04551352 reports 14 study locations spanning 8 distinct geographic areas — top geographies include Other, Ontario, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04551352?

The interventions under investigation include: Obinutuzumab (DRUG), Adalimumab (DRUG), Tocilizumab (DRUG), RO7293583 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04551352?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial