NCT07475572 Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
| NCT ID | NCT07475572 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Alvotech Swiss AG |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-08-10 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2026-08-10 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07475572 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07475572 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07475572 currently recruiting?
Yes, NCT07475572 is actively recruiting participants. Contact the research team at alvotech.clinical@alvotech.com for enrollment information.
Where is the NCT07475572 trial being conducted?
This trial is being conducted at Kiev, Ukraine.
Who is sponsoring the NCT07475572 clinical trial?
NCT07475572 is sponsored by Alvotech Swiss AG. The trial plans to enroll 120 participants.
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