A Randomized, Double-Blind, Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma

Sponsor
Alvotech Swiss AG
Study ID
NCT07475572
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AVT32-DRL_PB — BIOLOGICAL
    AVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks.
  • Keytruda — BIOLOGICAL
    Keytruda at a dose 200 mg administered intravenously every 3 weeks.

Study Details

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.

Key Dates

Start date
Jun 19, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Apr 14, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AVT32-DRL_PB
    AVT32-DRL\_PB will be administered during double blind period and open label period
  • Active Comparator: Keytruda
    Keytruda will be administered during double blind period

Primary Outcome Measure

To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab) [ Time Frame: Cycle 1 (each cycle is 21 days) ]

Central Contacts

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