Cancer
Conditions
Interventions
AVT32 DRL PB
Sponsors
Alvotech Swiss AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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.
Exclusion criteria
Exclusion criteria: ? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| To further characterize PK of AVT32-DRL_PB versus Keytruda To compare the Safety, efficacy and immunogenicity of AVT32-DRL_PB versus Keytruda | — |
Countries
South Africa
Contacts
Public ContactInge de Wet
Applicant Representative
Outcome results
None listed