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

Completed · Phase 1/Phase 2

Conditions studied: Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor, Microsatellite Stable (MSS) Colon Cancer

In brief

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.

Key facts

Study ID

NCT03711058

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

48

Starts

2019-01-17

Expected to finish

2025-06-30

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 have received any other investigational agents within 4 weeks prior to the first dose of treatment.
• Has received a live vaccine 30 days prior to the first dose of study drug.
• Has known additional malignancy that is progressing or requires active treatment..
• Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has symptomatic ascites or has required a paracentesis in the last 12 weeks.
• Hypersensitivity reaction to study drug.
• Patients diagnosed of immunodeficiency or are on any immunosuppressive agents within 7 days prior to first dose of study drug.
• Has active autoimmune disease that has required systemic treatment in the past 12 months, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Infection with HIV or hepatitis B or C.
• Cytomegalovirus polymerase chain reaction (CMV PCR) positive.
• Known history or concurrent interstitial lung disease.
• Type I diabetes or Type II diabetes requiring treatment with a sulfonylurea, meglitinide, or insulin at screening.
• Uncontrolled cardiovascular disease.
• Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Use of anti-arrhythmic therapy (beta blockers or digoxin are permitted).
• Use of CYP3A4 inhibitors and inducers within 2 weeks of starting study drug and throughout treatment.
• Any arterial or venous thrombotic or embolic events within 3 months of start of study drug.
• Non-healing wound, ulcer, or fracture.
• Patients with evidence or history of bleeding condition.

Where it is running

• Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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