Melanoma study: AVT32-DRL_PB vs Keytruda
Official title Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
ClinicalTrials.gov ID: NCT07475572
What this study is testing
What is AVT32-DRL_PB?
AVT32-DRL_PB is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 2 treatment group, repeated dose study to compare the PK, how well it works, safety, and immunogenicity of AVT32-DRL\_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in people with fully resected Stage IIB/C or Stage III melanoma requiring adjuvant treatment with pembrolizumab.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants (male/female) ≥18 years of age at the time of signing the ICF.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.
- Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma
You likely can't join if
- Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).
- Has received prior systemic anticancer therapy for melanoma including investigational agents.
- Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed \>5 years ago.
The study team makes the final eligibility decision.
Where it is enrolling
- Kiev, Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kiev, Ukraine. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.