Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IMC-20D7S (Cohort 1A)
IMC-20D7S · 1 trial · 1 indication
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
| Arm | Type | Description |
|---|---|---|
| IMC-20D7S (1A-4A Cohorts) | EXPERIMENTAL | Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A. |
| IMC-20D7S (1B-3B Cohorts) | EXPERIMENTAL | Escalating doses up to 30 mg/kg administered i.v. every 3 weeks; includes Cohorts 1B, 2B, and 3B. |
| Name | Type | Description |
|---|---|---|
| IMC-20D7S (Cohort 1A) | BIOLOGICAL | 5 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A. |
| IMC-20D7S (Cohort 2A) | BIOLOGICAL | 10 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A. |
| IMC-20D7S (Cohort 3A) | BIOLOGICAL | 20 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A. |
| IMC-20D7S (Cohort 4A) | BIOLOGICAL | 30 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. |
| IMC-20D7S (Cohort 1B) | BIOLOGICAL | 10 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B. |
| IMC-20D7S (Cohort 2B) | BIOLOGICAL | 20 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B. |
| IMC-20D7S (Cohort 3B) | BIOLOGICAL | 30 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. |
Inclusion Criteria: * Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy \[for example (e.g.), treatment with cytokines, monoclonal...