Copanlisib + Immunotherapy for Advanced Solid Cancers

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Timothy A Yap

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of copanlisib when given together with nivolumab and ipilimumab and to see how well they work in treating patients with solid cancers that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and have changes in PIK3CA and PTEN genes. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The addition of copanlisib to usual immunotherapy may work better in treating patients with solid cancers compared to usual immunotherapy alone.

Research Team

Timothy A Yap

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Eligibility Criteria

Adults with advanced solid cancers and specific gene changes (PIK3CA/PTEN) can join this trial. They must have a good performance status, controlled diabetes, measurable disease by certain criteria, and no recent other treatments. Pregnant or breastfeeding women, those with active infections or CNS metastases, and individuals on strong CYP3A4 inhibitors/inducers are excluded.

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1,500 /mcL

My cancer has spread, cannot be surgically removed, and standard treatments are not effective.

Platelets >= 100,000 / mcL

Exclusion Criteria

You are currently using any experimental drugs.

I have no severe allergies to copanlisib, PI3K inhibitors, nivolumab, or ipilimumab.

I am not taking strong drugs that affect how Copanlisib works.

Treatment Details

Interventions

• Copanlisib Hydrochloride (PI3K inhibitor)
• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview The trial is testing the effectiveness of adding Copanlisib to standard immunotherapy (Nivolumab with/without Ipilimumab) in treating advanced solid tumors with PIK3CA and PTEN mutations. It's a phase I/II study aiming to find the best dose while monitoring how well patients respond compared to usual treatment.

Participant Groups

Group I: Trial II (copanlisib, nivolumab, ipilimumab) Experimental Treatment 8 Interventions

Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15 of cycle 1. Beginning in cycle 2, patients also receive nivolumab IV over 60 minutes on day 1 and ipilimumab IV over 90 minutes every 8 weeks for 4 doses. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray and/or CT scan during screening and every 8 weeks, as well as a tumor biopsy at baseline, cycle 1 day 15, cycle 2 day 15, and every 3 weeks thereafter, and at disease progression. Patients also undergo blood sample collection at baseline, cycle 1 days 8 and 15, cycle 2 day 15, cycle 4 day 1 and disease progression. Patients undergo ECHO during screening and as clinically indicated on study.

Group II: Trial I (copanlisib, nivolumab) Experimental Treatment 7 Interventions

Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15 of cycle 1. Beginning in cycle 2, patients also receive nivolumab IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray and/or CT scan during screening and every 8 weeks, as well as a tumor biopsy at baseline, cycle 1 day 15, cycle 2 day 15, and every 3 weeks thereafter, and at disease progression. Patients also undergo blood sample collection at baseline, cycle 1 days 8 and 15, cycle 2 day 15, cycle 4 day 1 and disease progression. Patients undergo ECHO during screening and as clinically indicated on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School