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Optimization of Immunotherapy Treatment for Advanced Melanoma in the Context of the Public Brazilian Health System (OTIMAS)

NCT07376317 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-01-29

No results posted yet for this study

Summary

The OTIMAS study is a phase II trial designed to evaluate if the duration of one year of pembrolizumab immunotherapy for advanced metastatic melanoma has equivalent efficacy as the two-year duration of historical controls.

Conditions

Interventions

DRUG

Pembrolizumab

Patient will receive pembrolizumab 200mg IV Q3W for one year (17 cycles)

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2027-01-30
Completion
2027-01-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07376317 on ClinicalTrials.gov