Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL\_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage IIB/C or Stage III melanoma requiring adjuvant treatment with pembrolizumab. Eligible participants will be randomized in a 1:1 ratio to the AVT32-DRL\_PB or Keytruda treatment group and stratified by sex (female versus male) and body weight category (≤75 kg versus \>75 kg). Study treatments will be administered every 3 weeks (Q3W) as an intravenous (IV) infusion over 30 minutes (1 administration Q3W is 1 treatment cycle). The administered pembrolizumab dose will be 200 mg Q3W for both treatment groups.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Diagnoza czerniak skóry, stadium IIB, IIC lub III potwierdzone badaniem histologicznym
- •Dobry stan ogólny (zdolność do wykonywania codziennych czynności)
✗ Disqualifies
- •Wcześniejszy przeszczep narządu stałego lub przeszczep szpiku kostnego od dawcy
- •Poprzednie leczenie systemowe przeciwnowotworowe czerniak (w tym badawcze)
- •Historia czerniak błon śluzowych lub wnętrza oka, nawet jeśli zakończony ponad 5 lat temu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Site number 07010
Kiev, Ukraine
Trial contact
Clinical Development Lead
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/25/2026.
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