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A Randomized Double‑Blind Study of Pharmacokinetic Similarity of AVT32‑DRL_PB and Pembrolizumab in Patients with Resected Stage IIB‑C‑III Melanoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

People with melanoma that has been completely removed but is classified as stage IIB, IIC, or III are at risk for the cancer returning. After surgery, the study gives an intravenous (through a vein) infusion of either a new drug called AVT32-DRL_PB or the already approved medicine pembrolizumab, which is sold under the name Keytruda®. The medication is given in a hospital setting at regular intervals over several months.

The main aim of the trial is to find out whether the new drug behaves the same way in the body as the approved medicine. Participants receive the assigned infusion on a set schedule, with clinic visits for blood draws, simple heart checks, and occasional scans to look for any signs that the cancer has come back. Doctors also watch for any side effects and record any changes in laboratory tests.

After the treatment period, participants continue to be followed for up to a year to see how long they stay free of cancer and to monitor safety. The study records any problems that arise, checks hormone and blood levels, and measures the body’s response to the drug. All information is kept confidential and used only to understand the medicines better.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial infusion and baseline assessments
After joining the study, you will receive an intravenous infusion of 200 mg of pembrolizumab. the medication is given through a vein over a short period of time.
Before the infusion, a series of baseline tests will be performed, including blood tests, measurement of vital signs (blood pressure, heart rate, temperature), a 12‑lead electrocardiogram (ECG) to check heart rhythm, and a physical examination.
Step 2
Regular infusions (cycles 2 to 6)
You will receive additional intravenous infusions of 200 mg every 3 weeks. a total of six infusions (one every 3 weeks) are planned, covering approximately 18 weeks of treatment.
Step 3
Pharmacokinetic blood sampling
Blood will be drawn to measure the amount of drug in your body. samples are taken before each infusion and at specific times after the first dose and after the sixth dose (steady‑state) to evaluate how the drug is absorbed and cleared.
Step 4
Safety monitoring at each visit
At every infusion visit, you will undergo safety assessments that include repeat blood tests, vital‑sign measurements, an ECG, and a brief physical examination to detect any adverse events (side effects).
Any side effects will be recorded and graded according to standard criteria, and serious or treatment‑related events will be reported to the study team.
Step 5
Efficacy follow‑up (recurrence‑free survival)
After the last infusion, you will be followed for up to week 51 to monitor for cancer recurrence. this follow‑up involves periodic clinical visits and imaging as instructed by the protocol.
Step 6
Final study assessments and completion
At the end of the follow‑up period, final assessments will be performed, including blood tests for anti‑drug antibodies, evaluation of any remaining side effects, and a summary of all study measurements.

Who can join the trial?

4 criteria

Be 18 years old or older at the time you sign the consent form.
Have a diagnosis of Stage IIB, IIC, or III cutaneous (skin) melanoma that was confirmed by looking at tissue under a microscope, and have had the tumor completely removed with negative surgical margins (no cancer cells at the edge of the removed tissue). You must not have any past or current satellite (small nearby) or in‑transit metastases (cancer spread along skin pathways).
After surgery, your disease status must be documented with a full CT (computed tomography) or MRI (magnetic resonance imaging) scan of the chest, abdomen, and pelvis, plus a neck scan if the original tumor was in the head or neck area, and a complete clinical examination, all done before enrollment.
Have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to do light work (1) without being bedridden.

Who cannot join the trial?

5 criteria

Having another active cancer (malignancy) within the past 3 years, unless it was a skin cancer like basal or squamous cell cancer, a very early bladder cancer, or a non‑invasive (carcinoma in situ) cancer of the prostate, cervix, or breast that could be cured with local treatment.
Having a history of mucosal melanoma (melanoma that occurs on the lining of body cavities) or uveal melanoma (melanoma of the eye), even if it was diagnosed and treated more than 5 years ago.
Having received a solid organ transplant (such as a kidney, liver, or heart) or a bone‑marrow/stem‑cell transplant that used donor cells (called an allogenic transplant).
Having been treated before with medicines that block the PD‑1, PD‑L1, or PD‑L2 pathways, or with other drugs that target T‑cell receptors such as CTLA‑4, OX‑40, or CD137.
Having received any previous systemic (whole‑body) anticancer treatment for melanoma, including experimental (investigational) drugs.

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Verified sites

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Centrul De Oncologie SF Nectarie S.R.L.
Craiova, Romania
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcon, Spain

Trial locations

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Investigated drugs

KEYTRUDA
is a medicine that helps the body’s immune system find and fight melanoma cancer cells. In this study it is used as the standard treatment to compare against the new version being tested. Patients receive it through an IV (a needle placed into a vein) after their tumor has been completely removed, and the researchers look at how the drug moves in the body, how well it works, and any side effects.
Pembrolizumab
is an investigational form of the same type of immune‑boosting medicine. It is also given by IV infusion after surgery to remove the melanoma. The study uses this drug to see if it behaves the same way as KEYTRUDA in terms of how it is processed in the body, how effective it is at preventing cancer from coming back, and how safe it is for patients.

Pembrolizumab

What is already known about the treatment

KEYTRUDA 25 mg/mL concentrate for solution for infusion
This medication is given by an IV infusion, where the liquid is slowly dripped into a vein. It is an approved drug that is widely used in medical practice and described in many scientific papers. It is mainly used to treat melanoma and several other types of cancer after surgery. It works by attaching to a protein called PD‑1 on immune cells, blocking the signal that tells the immune system to stand down, so the body can better attack cancer cells. It belongs to the class of immune checkpoint inhibitors, a type of anti‑cancer (antineoplastic) therapy.
Pembrolizumab
This drug is also administered by intravenous infusion, using a concentrate that is mixed with a solution before it is given. It is a recognized, approved therapy that appears in current medical literature and guidelines. It is intended for use as an additional treatment for patients with stage IIB/C‑III melanoma after the tumor has been completely removed. It acts by binding to the PD‑1 receptor on immune cells, preventing the cancer from turning off the immune response, thereby helping the body fight the tumor. It is classified as an immune checkpoint inhibitor in the antineoplastic drug group.

Investigated diseases

Stage IIB–IIIC melanoma - Melanoma is a type of skin cancer that begins in pigment‑producing cells called melanocytes. In stages IIB to IIIC, the tumor has grown deeper into the skin and may have spread to nearby lymph nodes, but it has not yet reached distant organs. The disease can progress from a localized lesion to involvement of regional lymph nodes, and further growth can increase the depth of invasion. As the cancer advances, the number of affected lymph nodes and the thickness of the primary tumor typically increase.