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| Name | Class |
|---|---|
| Dr. Reddy's Laboratories Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVT32-DRL_PB | Experimental | AVT32-DRL_PB will be administered during double blind period and open label period |
|
| Keytruda | Active Comparator | Keytruda will be administered during double blind period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVT32-DRL_PB | Biological | AVT32-DRL_PB at a dose 200 mg administered intravenously every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab) | AUC0-3w (Cycle 1) | Cycle 1 (each cycle is 21 days) |
| To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab) | AUCtau,ss (Cycle 6) | Cycle 6 (each cycle is 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Lead | Contact | +41 78 659 8989 | alvotech.clinical@alvotech.com |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| Keytruda | Biological | Keytruda at a dose 200 mg administered intravenously every 3 weeks. |
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |