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Report for Clinical Trial NCT03711058

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03711058 Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor Along With Microsatellite Stable (MSS) Colon Cancer Colon Cancer
MeSH:Colonic Neoplasms
HPO:Colon cancer Neoplasm of the colon

2 Interventions

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 IV
Type: Drug
Group Labels: 2

Phase 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 IV
Type: Drug
Group Labels: 2

Phase I - Copanlisib and Nivolumab (De-Escalation) Phase II - Copanlisib and Nivolumab


Primary Outcomes

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 years

Description: 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-months

Secondary Outcomes

Description: 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-months

Description: 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-months

Description: Number of months from treatment to disease progression (PD)

Measure: Progression free survival (PFS) status at 6 months.

Time: 6-months

Description: 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-months

Description: 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 years

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There is one SNP

SNPs


1 P13K

- Prior therapy with a P13K inhibitor - Chemotherapy, radiotherapy, investigational therapy, or surgery within 4 weeks prior to first dose of treatment. --- P13K ---



HPO Nodes


HPO: