Biosimilar to Keytruda for fully resected melanoma
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
Run by Alvotech Swiss AG · NCT07475572 · Data updated 2026-11-12
This study tests whether AVT32-DRL_PB, a proposed biosimilar to Keytruda, works similarly to pembrolizumab in adults with fully resected stage IIB/C or III melanoma who need adjuvant therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Alvotech Swiss AG Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 1 site (Kiev) |
| Status | Recruiting |
| Started | August 10, 2026 |
| Main results expected | October 2027 |
| Study ends | April 14, 2028 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07475572 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with stage IIB/IIC or III cutaneous melanoma, ECOG 0-1, and no prior systemic melanoma therapy.
✕Probably not a fit
Patients with prior systemic melanoma therapy, mucosal or uveal melanoma, or those not meeting ECOG or stage criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, double-blind, parallel-group Phase 1 trial comparing AVT32-DRL_PB to Keytruda in adults with fully resected melanoma. Participants receive intravenous pembrolizumab 200 mg every 3 weeks for a planned treatment cycle, with randomization 1:1 between the biosimilar and Keytruda. The study evaluates pharmacokinetics, safety, immunogenicity, and preliminary efficacy of the two treatments. Participants are stratified by sex and weight, and treatment continues every 3 weeks as an infusion. Primary data focus includes whether the biosimilar matches Keytruda in exposure and safety profile during adjuvant therapy.
Why it matters
Potential benefit: If successful, the biosimilar could provide a comparable treatment option to Keytruda for melanoma patients who have had surgery and require adjuvant therapy.
How similar studies have gone: Previous biosimilar studies have shown comparable PK and safety to originator therapies in multiple cancers; this trial applies that approach to pembrolizumab.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Site number 07010
Kiev, Ukraine Recruiting
Study contacts
- Study coordinator: Clinical Development Lead
- Email: alvotech.clinical@alvotech.com
- Phone: +41 78 659 8989
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.