Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Copanlisib · 1 trial · 2 indications
Number of participants experiencing a Dose Limiting Toxicity (DLT) in each dose level. DLT is defined as any of the following study drug-related toxicities occurring during the first cycle of study drug on study: * Grade 4 anemia * Grade ≥ 3 neutropenia lasting ≥ 14 days * Grade ≥ 3 febrile neutropenia * Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with clinically significant bleeding * Treatment-related ≥ grade 4 AEs, except transient hyperglycemia * Grade ≥ 3 Pneumonitis or recurrent Grade 2 pneumonitis * Grade ≥ 3 Nephritis * Grade ≥ 3 elevated AST or ALT * Grade ≥ 2 eye pain or reduction of visual acuity that does not respond to topical therapy, improve to ≤ grade 1 within 2 weeks of topical therapy, or requires systemic therapy * Any other Grade ≥ 3 toxicities (with certain exceptions for transient AEs or asymptomatic labs)
The proportion of subjects with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per RECIST 1.1, complete response is defined as disappearance of all target lesions, and partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Lesions are assessed by CT or MRI.
| Arm | Type | Description |
|---|---|---|
| Phase I - Copanlisib and Nivolumab (De-Escalation) | EXPERIMENTAL | - |
| Phase II /Arm A-P13K mutation/Copanlisib and Nivolumab | EXPERIMENTAL | - |
| Phase II/Arm B -P13K wild type /Copanlisib and Nivolumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Copanlisib | DRUG | Copanlisib will be administered as a 60 minute IV infusion (-5min/+10min) at a dose of 45 mg - 60 mg IV. Copanlisib will be administered once a week (days 1, 8, and 15 or Day 1 and Day 15 of each 28 day cycle). Drug: 45 or 60 mg IV |
| Nivolumab | DRUG | Nivolumab 480 mg will be administered as a 30 minute IV infusion (-5min/+10min) on Day 1 of each 28 day cycle. Drug: 480 mg IV |
Inclusion Criteria: * Age ≥18 years. * Ability to understand and willingness to sign a written informed consent document. * Phase I: Must have received all curative treatment options and at least 2 lines of systemic therapy. * Phase II: Must have received at least 2 lines of systemic therapy includ...