Clinical trial · Interventional
Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVT32-DRL_PB | Biological | — | UNRESOLVED |
| Keytruda | Biological | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AVT32-DRL_PB
- description
- AVT32-DRL\_PB will be administered during double blind period and open label period
- interventionNames
- Biological: AVT32-DRL_PB
- type
- ACTIVE_COMPARATOR
- label
- Keytruda
- description
- Keytruda will be administered during double blind period
- interventionNames
- Biological: Keytruda
Primary outcomes (2)
- measure
- To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
- timeFrame
- Cycle 1 (each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available