Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607535799083 Date of Registration: 31/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomized, Double-Blind, Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB with Keytruda® in Participants with Fully Resected Melanoma (AVT32-DRL-TPK-02).
Official scientific title 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
Brief summary describing the background and objectives of the trial 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. The double-blind treatment period (DBTP) will be from Cycle 1 Day 1 (Week 0) up to and including Cycle 8 (including procedures prior to dosing during Cycle 9) or until discontinuation of the study treatment for other reasons (eg, disease recurrence, unacceptable toxicity), whichever occurs first. The main data analysis will be performed after all participants have completed 8 cycles of comparative treatment when the primary PK endpoint will be evaluated. After the DBTP is completed (with assessments performed at the end of Cycle 8; predose Cycle 9), participants who do not have disease recurrence will be given the option to enter the open-label extension period (OLEP) of the study. Disease recurrence should be evaluated before the participant enters the OLEP if they have not had a tumor assessment within the previous 4 weeks. Participants originally receiving AVT32-DRL_PB in the DBTP will continue to receive open-label AVT32-DRL_PB, and participants originally receiving Keytruda will switch to open-label AVT32-DRL_PB. The total treatment duration (DBTP and OLEP combined) with AVT32-DRL_PB or Keytruda followed by AVT32-DRL_PB will be up to a maximum of 12 months
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PK Biosimilar
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/09/2026
Actual trial start date
Anticipated date of last follow up 05/08/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
DOH-27-072026-8439 SANCTR
2025-525093-11-00 EUCTR
AVT32-DRL-TPK-02 Sponsor
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group AVT32 DRL PB 25 mg/mL (100 mg/4 mL)- 200 mg (2 complete vials) Q3W approximately 17 cycles of treatment. No clinical studies have been conducted with AVT32-DRL_PB to date. Since AVT32-DRL_PB is being developed as a proposed biosimilar for the approved drug Keytruda, it is expected that the clinical risks and benefits will be comparable to those observed for Keytruda. 12
Control Group Keytruda 25 mg/mL (100 mg/4 mL)-200 mg (2 complete vials) Q3W Treatment will continue for up to 8 cycles inclusive, or until discontinuation of the study treatment for other reasons (eg, disease recurrence, unacceptable toxicity, or any criterion for treatment discontinuation Registered Oncology treatment 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Participants (male/female) ≥18 years of age at the time of signing the ICF  Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma (as classified by the American Joint Committee on Cancer’s Cancer Staging Manual, 8th Edition) who have undergone complete resection with negative surgical margins. No evidence of past or current satellites or in-transit metastases.  Disease status for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) or magnetic resonance imaging (MRI) with neck CT and/or MRI (for head and neck primaries) and by a complete clinical examination after the informed consent form (ICF) has been signed and before enrollment.  Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.  Prior active malignancy within the previous 3 years except for locally curable cancers that undergone potentially curative therapy, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.  Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed >5 years ago.  Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).  Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)  Has received prior systemic anticancer therapy for melanoma including investigational agents. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 104 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/06/2026 SAHPRA
Ethics Committee Address
Street address City Postal code Country
Loftus Park,Building A,402 Kirkness Street,Arcadia, Pretoria 0083 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/07/2026 THE SOUTH AFRICAN MEDICAL ASSOCIATION NPC
Ethics Committee Address
Street address City Postal code Country
Block F Castle Walk Corporate Park, Nossob Street, Erasmuskloof Ext3, Pretoria 0181 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab) Area under the concentration-time curve from time 0 to 3 weeks (AUC0-3w) (Cycle 1) Area under the concentration-time curve over the dosing interval at steady-state (AUCtau) (Cycle 6) AUC0-3w: Cycle 1 AUCtau: C6
Secondary Outcome To further characterize PK of AVT32-DRL_PB versus Keytruda To compare the Safety, efficacy and immunogenicity of AVT32-DRL_PB versus Keytruda Throughout the whole study duration, up to week 51
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Medical Oncology Centre Rosebank 129 Oxford Road, CNR Northwold, Saxonwold Johannesburg 2196 South Africa
Phoenix Pharma Pty Ltd 2 Eastbourne Rd, Mt Croix Port Elizabeth 6001 South Africa
Wits Clinical Research 32 Princess of Wales Terrace, Sunnyside Office Park, Building C, Level 2, Parktown Johannesburg 2193 South Africa
Mary Potter Oncology Centre Life Groenkloof Hospital, 50 Totius street, Groenkloof Pretoria 0181 South Africa
Excellentis 2nd floor, 72 York Building,72 York Street George 6529 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Alvotech Swiss AG Thurgauerstrasse 54, Zurich CH-8050 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alvotech Swiss AG Thurgauerstrasse 54 Zurich CH-8050 Switzerland Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Syneos Health South Africa 23 Donald Murry Ave, 2nd Floor, Park West, Bloemfontein 9321 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernardo Rapoport brapoport@rapoport.co.za 0118804169 The Medical Oncology Centre,129 Oxford Road, CNR Northwold, Saxonwold
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa National Principal Investigator
Role Name Email Phone Street address
Public Enquiries Inge de Wet inge.dewet@syneoshealth.com +2782057885 23 Donald Murry Ave, 2nd Floor, Park West,Free State,
City Postal code Country Position/Affiliation
Bloemfotein 9321 South Africa Applicant Representative
Role Name Email Phone Street address
Scientific Enquiries Clinical Developement Lead alvotech.clinical@alvotech.com +41786598989 Thurgauerstrasse 54
City Postal code Country Position/Affiliation
Zurich 8050 Switzerland Sponsor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No sharing of IPD Clinical Study Report,Statistical Analysis Plan,Study Protocol Results of this study will be submitted to the Clinical Trial Information System within 1 year of the end of the study. Both the use of data and the publication policy are detailed within the clinical study agreement. Intellectual property rights (and related matters) generated by the investigator and others performing the clinical study will be subject to the terms of a clinical study agreement that will be agreed between the institution and the sponsor or its designee. With respect to such rights, the sponsor or its designee will solely own all rights and interests in any materials, data, and intellectual property rights developed by investigators and others performing the clinical study described in this protocol, subject to the terms of any such agreement. To facilitate such ownership, investigators will be required to assign all such inventions either to their institution or directly to the sponsor or its designee, as will be set forth in the clinical study agreement. This study will be registered within EMA Clinical Trial Information System. Results of this study will be submitted to the Clinical Trial Information System within 1 year of the end of the study. Regardless of the outcome of a study, the sponsor is dedicated to openly providing information on the study to healthcare professionals and to the public, at scientific congresses, in clinical study registries, and in peer-reviewed journals. The sponsor will comply with all requirements for publication of study results. Redacted CSRs and other summary reports may be made available upon request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information