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Monoclonal Antibodies

RO7293583 for Melanoma

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 24 months.
Awards & highlights

Study Summary

This trial is testing a new drug, RO7293583, to treat people with melanoma that has spread and is not able to be removed by surgery. The study will test different doses of the drug to see what is safe and works best.

Eligible Conditions
  • Melanoma
  • Skin Cancer
  • Uveal Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Percentage of Participants with Adverse Events (AEs)
Secondary outcome measures
Area Under the Curve (AUC) of RO7293583
Change from Baseline in RO7293583 ADA Titer
Clearance (CL) or Apparent Clearance (CL/F) of RO7293583
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part II: Multiple Participant Cohorts (IV/SC)Experimental Treatment4 Interventions
Multiple ascending dose-escalation of RO7293583 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation will be determined by Part I and RO7293583 will be administered IV or SC every 3 weeks. Dose-escalation will be undertaken based on safety until determination of the MTD or the highest safe dose if MTD is not reached. Fractionated, step up or subcutaneous dosing may be implemented. The maximum dose explored will be 600mg IV and 160mg SC.
Group II: Part I: Single Participant Cohorts (IV)Experimental Treatment2 Interventions
Part I is a dose escalation in single participant cohorts. RO7293583 will be administered intravenously (IV) every three weeks (Q3W). The starting dose will be 0.045mg and the maximum dose explored will be 1.5mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7293583
2020
Completed Phase 1
~20
Adalimumab
2013
Completed Phase 4
~6480
Tocilizumab
2012
Completed Phase 4
~1840
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,402 Total Patients Enrolled
49 Trials studying Melanoma
58,484 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,200 Previous Clinical Trials
888,502 Total Patients Enrolled
50 Trials studying Melanoma
42,899 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas
2020. "A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04551352.
~5 spots leftby Apr 2025
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