A Randomized, Double-Blind, 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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07475572

Enrollment

120

Registered

2026-03-16

Start date

2026-06-19

Completion date

2028-04-14

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

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

BIOLOGICALAVT32-DRL_PB

AVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks.

BIOLOGICALKeytruda

Keytruda at a dose 200 mg administered intravenously every 3 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)	Cycle 1 (each cycle is 21 days)	AUC0-3w (Cycle 1)

Contacts

CONTACTClinical Development Lead

alvotech.clinical@alvotech.com+41 78 659 8989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026