Table 3b.
Parameter, n (%) | Delayed cohort (dose-finding part only) (n = 10) | |||
---|---|---|---|---|
nab-Paclitaxel | Carboplatin | Nivolumab | nab-Paclitaxel/carboplatin/nivolumab | |
Patients with ≥1 TEAE leading to dose reduction or interruptiona | 8 (80.0) | 6 (60.0) | 1 (10.0) | 8 (80.0) |
Patients with ≥1 TEAE leading to withdrawal of study drug | 1 (10.0) | 1 (10.0) | 2 (20.0) | 2 (20.0) |
Most common TEAEs leading to dose reduction and/or interruptionb Neutropenia |
4 (40.0) | 2 (20.0) | 0 | 4 (40.0) |
Platelet count decreased | 2 (20.0) | 1 (10.0) | 0 | 2 (20.0) |
Fatigue | 2 (20.0) | 1 (10.0) | 0 | 2 (20.0) |
Most common TEAEs leading to withdrawal of study drugc Myelopathy |
0 | 0 | 1 (10.0) | 1 (10.0) |
Pneumonitis | 0 | 0 | 1 (10.0) | 1 (10.0) |
Platelet count decreased | 1 (10.0) | 1 (10.0) | 0 | 1 (10.0) |
TEAE, treatment-emergent adverse event.
For nivolumab, because dose reductions were not allowed, the numbers represent patients with dose interruption.
Occurring in >1 patient in any group, presented in descending order of incidence in the nab-paclitaxel/carboplatin/nivolumab group.
Due to small numbers, all TEAEs leading to withdrawal are listed.