A phase I/II study of PI3Kinase inhibition (copanlisib) and anti-PD-1 antibody nivolumab in relapsed/refractory solid tumors with expansions in mismatch-repair proficient (MSS) colorectal cancer.
Name: Copanlisib
Description: 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 IVType: DrugPhase I - Copanlisib and Nivolumab (De-Escalation) Phase II - Copanlisib and Nivolumab
Name: Nivolumab
Description: Nivolumab 480 mg will be administered as a 60 minute IV infusion (-5min/+10min) on Day 1 of each 28 day cycle. Drug: 480 mg IVType: DrugPhase I - Copanlisib and Nivolumab (De-Escalation) Phase II - Copanlisib and Nivolumab
Description: Number of patients having a dose limiting toxicities (DLT) at each level.
Measure: Determine maximum tolerated dose (MTD) of copanlisib with fixed dose nivolumab Time: 2 yearsDescription: The proportion of subjects with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measure: 6-month objective response rate (ORR) of patients treated with copanlisib and nivolumab Time: 6-monthsDescription: Percentage of participants achieving stable disease (SD) or better (SD + partial response (PR) + (CR).
Measure: Disease control rate (DCR) status at 6 months. Time: 6-monthsDescription: Number of months from the first documentation of a response to date of disease progression.
Measure: Duration of response (DOR) status at 6 months. Time: 6-monthsDescription: Number of months from treatment to disease progression (PD)
Measure: Progression free survival (PFS) status at 6 months. Time: 6-monthsDescription: Number of months from the date of first treatment until death or end of follow-up.
Measure: Overall survival (OS) status at 6 months. Time: 6-monthsDescription: Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.
Measure: Number of participants experiencing study drug-related toxicities Time: 2 yearsAllocation: Non-Randomized
Sequential Assignment
There is one SNP
- Prior therapy with a P13K inhibitor - Chemotherapy, radiotherapy, investigational therapy, or surgery within 4 weeks prior to first dose of treatment. --- P13K ---