NCT07475572 is a Phase 1 clinical trial of AVT32-DRL_PB in Melanoma, sponsored by Alvotech Swiss AG.

Who is sponsoring NCT07475572?

NCT07475572 is sponsored by Alvotech Swiss AG.

What drugs are being tested in NCT07475572?

Interventions in NCT07475572: AVT32-DRL_PB, Keytruda.

Is NCT07475572 still recruiting?

NCT07475572 is currently not yet recruiting. Last updated 11 March 2026.

Last reviewed 2026-03-11 · How we verify

NCT07475572

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Not yet recruiting Phase 1 Last updated 11 March 2026

What this trial tests

Phase 1 trial testing AVT32-DRL_PB in Melanoma in 120 participants. Not yet recruiting.

Timeline

19 June 2026

Primary endpoint
1 October 2027

14 April 2028

Quick facts

Lead sponsor	Alvotech Swiss AG
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	19 June 2026
Primary completion	1 October 2027
Estimated completion	14 April 2028

Drugs / interventions tested

AVT32-DRL_PB — full drug profile →
Keytruda (pembrolizumab) — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →

Sponsor

Alvotech Swiss AG — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
Time frame: Cycle 1 (each cycle is 21 days)
AUC0-3w (Cycle 1)
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
Time frame: Cycle 6 (each cycle is 21 days)
AUCtau,ss (Cycle 6)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other Alvotech Swiss AG trials

Trials by the same sponsor.

NCT06732804 — Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio · Phase 1 · completed
NCT06570772 — Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio · Phase 3 · terminated
NCT06400719 — Pilot Study of AVT16 in Healthy Adult Subjects · Phase 1 · completed
NCT05986786 — Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease · Phase 3 · completed
NCT05876949 — AVT03 With Xgeva in Healthy Male Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07475572 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alvotech Swiss AG
Last refreshed: 11 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07475572.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing