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

NCT07376317 | Active Not Recruiting Phase 2

• 1 other identifier: NP 1957/2021
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Melanoma Metastatic; Melanoma Recurrent; Cutaneous Melanoma; Stage IV Melanoma

Keywords

Pembrolizumab; Optimization of immunotherapy treatment; advanced melanoma; cutaneous melanoma; metastatic melanoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  24 months

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

Pembrolizumab 200mg IV Q3W for one year (17 cycles)

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

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

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with malignant melanoma (with confirmed histopathological diagnosis) stages III and IV not amenable to locoregional treatment or curative treatment
• Measurable disease by RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
• Up to 1 (one) line of prior treatment with palliative chemotherapy (monotherapy), with documented progression and no residual toxicities greater than grade 1 according to CTCAE
• Estimated life expectancy greater than 12 weeks
• Adequate renal function, defined as creatinine clearance estimated by the Cockcroft-Gault equation equal to or greater than 30 mL/min;
• Adequate liver function, defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels equal to or less than 2.0 times the upper limit of normal and total bilirubin less than 2 times the upper limit of normal;
• Hemoglobin greater than or equal to 8 g/dL; neutrophil count equal to or greater than 1,000/mm3; platelet count equal to or greater than 100,000/mm3;
• Ability to understand and adhere to study procedures;
• Age over 18 years;
• Absence of active treatment for the underlying disease, with the exception of the use of bisphosphonates;

You may not qualify if:

• Uncontrolled Central Nervous System (CNS) metastases: active symptomatic disease in the central nervous system, requiring doses of corticosteroids greater than the equivalent of 10 mg/day of prednisone. Patients previously submitted to local treatment, such as radiotherapy, will be eligible if they have demonstrated clinical stability in the 2 weeks prior to the start of treatment;
• Diagnosis of uveal or mucosal melanoma;
• Diagnosis of acral melanoma;
• Leptomeningeal disease
• Pregnancy; effective contraceptive methods should be recommended to women of childbearing age;
• Uncontrolled associated disease;
• Known active hepatitis B and C;
• HIV with detectable viral load or CD4\<350;
• Active autoimmune disease with use of immunosuppressive therapy or history of autoimmune disease whose risk of recurrence is considered high by the investigator;
• More than one line of prior systemic therapy in the context of metastatic or advanced disease or prior use of polychemotherapy;
• Prior use of anti-PD-1 in the (neo)adjuvant setting;
• Concomitant active malignant neoplasia;
• History of malignant neoplasia in the last 5 years, with the exception of squamous cell carcinoma, basal cell carcinoma of the skin, in situ tumors, prostate adenocarcinoma gleason \<=6;
• Infection with systemic involvement in the last 2 weeks;
• Use of corticosteroids in a dose equivalent to greater than 10 mg/d of prednisone on a continuous basis.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

ICESP

São Paulo, São Paulo, 01246000, Brazil

Location

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Milena Mak

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: December 10, 2021
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

BR (1)