A Randomized, Double-Blind, Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AVT32-DRL_PB, Keytruda.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants With Stage IIB/C-III Melanoma Following Complete Resection
Overview
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.
Interventions
- Biological AVT32-DRL_PB
AVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks. - Biological Keytruda
Keytruda at a dose 200 mg administered intravenously every 3 weeks.
Primary outcome measures
- To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab) [Time frame: Cycle 1 (each cycle is 21 days)]
- To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab) [Time frame: Cycle 6 (each cycle is 21 days)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07475572 · AVT32-DRL-TPK-02