Could one year of immunotherapy be enough for advanced melanoma?
NCT ID NCT07376317
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether one year of pembrolizumab (an immunotherapy drug) works as well as the standard two-year course for people with advanced melanoma that cannot be surgically removed. The study involves 29 participants in Brazil's public health system and measures how long the cancer stays under control. If successful, it could mean less time on treatment and lower costs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pembrolizumab (an immunotherapy drug that helps the immune system fight cancer)
- What this could lead to
- If successful, this could show that a shorter course of immunotherapy is just as effective, reducing treatment burden and costs for patients with advanced melanoma.
- What could go wrong
- This is a small, early-phase trial with only 29 participants, so results may not apply broadly. There is a risk that one year of treatment is less effective than two years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
29 people
The number who actually took part.
- Started
-
Dec 2021
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; Exclusion Criteria: * 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. * History of solid organ transplantation under immunosuppression.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ICESP
São Paulo, São Paulo, 01246000, Brazil
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Other studies related to the condition(s) this trial covers.
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