Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractor… (NCT03711058) | Clinical Trial Compass
CompletedPhase 1/2
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
United States48 participantsStarted 2019-01-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 including a fluoropyrimidine, oxaliplatin, and irinotecan-containing regimen. KRAS/NRAS/BRAF wildtype patients must have received or refused anti-EGR.
* Must have received all curative treatment options and at least 2 lines of systemic and standard therapy.
* Must have measurable disease based on RECIST 1.1
* Must have biopsiable disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Life expectancy of greater than 3 months.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests within 21 days of initial study drug.
* Men must use acceptable form of birth control while on study.
* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
Exclusion Criteria:
* Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti- PD-L2, anti-CTLA4, etc.).
* Prior therapy with a PI3K inhibitor
* Chemotherapy, target small molecule therapy, investigational therapy, or surgery within 4 weeks prior to first dose of treatment.
* Has received prior radiotherapy within 2 weeks prior to the start of treatment.
* Patient who is receiving or hav…
What they're measuring
1
Number of Participants Experiencing a Dose Limiting Toxicity
Timeframe: 28 days
2
6-month Objective Response Rate (ORR) of Patients Treated With Copanlisib and Nivolumab
Timeframe: 6-months
Trial details
NCT IDNCT03711058
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins