Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02523469 | ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer | PHASE1 | COMPLETED | 67 | — | — | Jan 8, 2016 | Feb 24, 2023 | Feb 17, 2026 | 4 | United States |
A continual reassessment method (CRM) design will be used to identify the maximum tolerated dose (MTD) for Phase Ib patients
The phase II portion of the study looks to define the objective response rate (using immune-related RECIST) of ALT-803 added to nivolumab in patients with advanced and unresectable non-small cell lung cancer. Objective response rate will be defined by the best overall response, which is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg | EXPERIMENTAL | Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg | EXPERIMENTAL | Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg | EXPERIMENTAL | Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 4: ALT-803 20 µg/kg + Nivolumab 3 mg/kg (RP2D) | EXPERIMENTAL | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) | EXPERIMENTAL | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population |
| Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) | EXPERIMENTAL | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure |
| Exploratory Arm 1 | NO_INTERVENTION | ALT-803 ± Nivolumab for biomarker analysis only |
| Exploratory Arm 2 | NO_INTERVENTION | ALT-803 ± Nivolumab for biomarker analysis only |
| Name | Type | Description |
|---|---|---|
| ALT-803 | BIOLOGICAL | ALT-803 administered IV at doses per arm (6, 10, 15, 20 µg/kg) |
| Nivolumab | BIOLOGICAL | Nivolumab administered IV at 3 mg/kg per protocol |
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of NSCLC who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) or recurrent disease following radiation therap...