Melanoma MetastaticPhase 2OTIMASNCT07376317
Optimization of Immunotherapy Treatment for Advanced Melanoma in the Context of the Public Brazilian Health System (OTIMAS)
A Phase 2 study testing Pembrolizumab in people with Melanoma Metastatic and Melanoma Recurrent, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Metastatic, Melanoma Recurrent, Cutaneous Melanoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Dec 2021to 30 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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.
- History of solid organ transplantation under immunosuppression.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The development of immune checkpoints inhibitors marked a new era in the treatment of melanoma patients. The use these therapies has more than doubled the expected median overall survival of patients with metastatic melanoma compared with chemotherapy At 5-year follow-up, the median overall survival of patients treated with nivolumab, an anti-PD-1 agent, was 37.3 months compared with 11.2 months in the group treated with dacarbazine, a chemotherapy agent, which represented a 50% reduction in the risk of death with a hazard ratio (HR) of 0.5 (95% CI, 0.40 to 0.63; P < .0001). However, these revolutionary therapies are accessible only to a minority of the Brazilian population, as chemotherapy remains the standard of care for patients with advanced melanoma treated by the Brazilian public health system (Sistema Único de Saúde - SUS), which covers more than 70% of the population.
No published study has specifically evaluated the optimal treatment time with immune checkpoint inhibitors. In studies with nivolumab, treatment was administered until progression or limiting toxicities, whereas in studies with another PD-1 inhibitor, pembrolizumab, treatment was administered for two years.
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.
In this study, patients with advanced (metastatic or unresectable) cutaneous melanoma are treated with pembrolizumab 200mg every 3 weeks for a maximum duration of 12 months. Efficacy will be measured according to RECIST v1.1 criteria, with progression-free survival (PSF) in 24 months as the primary endpoint, compared to historical control. Additionally, the study will assess microRNAs as possible biomarkers in the responders. Other secondary analysis include: quality of life by EORTC QLC-C30 and EuroQol-3L and cost-effectiveness (12 versus 24 months) in the context of Brazilian health system.
This trial is being conducted at Institute of Cancer of the State of São Paulo (ICESP), with an estimated duration of four years.
- Being tested
- Pembrolizumab
- Keywords
- Pembrolizumab, Optimization of immunotherapy treatment, advanced melanoma, cutaneous melanoma, metastatic melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Patient will receive pembrolizumab 200mg IV Q3W for one year (17 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | Pembrolizumab 200mg IV Q3W for one year (17 cycles) Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start10 Dec 2021
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milena Mak, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376317
- Sponsor's protocol ID
- NP 1957/2021
- Acronym
- OTIMAS
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Immunotherapy Treatment for Advanced Melanoma in the Context of the Public Brazilian Health System (OTIMAS)
- ClinicalTrials.gov ID
- NCT07376317
- Acronym / sponsor ID
- OTIMAS / NP 1957/2021
- Keywords
- Pembrolizumab, Optimization of immunotherapy treatment, advanced melanoma, cutaneous melanoma, metastatic melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The development of immune checkpoints inhibitors marked a new era in the treatment of melanoma patients. The use these therapies has more than doubled the expected median overall survival of patients with metastatic melanoma compared with chemotherapy At 5-year follow-up, the median overall survival of patients treated with nivolumab, an anti-PD-1 agent, was 37.3 months compared with 11.2 months in the group treated with dacarbazine, a chemotherapy agent, which represented a 50% reduction in the risk of death with a hazard ratio (HR) of 0.5 (95% CI, 0.40 to 0.63; P < .0001). However, these revolutionary therapies are accessible only to a minority of the Brazilian population, as chemotherapy remains the standard of care for patients with advanced melanoma treated by the Brazilian public health system (Sistema Único de Saúde - SUS), which covers more than 70% of the population.
No published study has specifically evaluated the optimal treatment time with immune checkpoint inhibitors. In studies with nivolumab, treatment was administered until progression or limiting toxicities, whereas in studies with another PD-1 inhibitor, pembrolizumab, treatment was administered for two years.
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.
In this study, patients with advanced (metastatic or unresectable) cutaneous melanoma are treated with pembrolizumab 200mg every 3 weeks for a maximum duration of 12 months. Efficacy will be measured according to RECIST v1.1 criteria, with progression-free survival (PSF) in 24 months as the primary endpoint, compared to historical control. Additionally, the study will assess microRNAs as possible biomarkers in the responders. Other secondary analysis include: quality of life by EORTC QLC-C30 and EuroQol-3L and cost-effectiveness (12 versus 24 months) in the context of Brazilian health system.
This trial is being conducted at Institute of Cancer of the State of São Paulo (ICESP), with an estimated duration of four years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Experimental | Drug: PembrolizumabPembrolizumab 200mg IV Q3W for one year (17 cycles) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPatient will receive pembrolizumab 200mg IV Q3W for one year (17 cycles) | Drug | Pembrolizumab |
Primary outcome
Progression free survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Melanoma Metastatic and Melanoma Recurrent, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.