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Copanlisib + Avelumab for Advanced Bladder Cancer

Phase 1 & 2

Waitlist Available

Led By Chong-Xian Pan, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate bone marrow function

Documented stage IV disease (T4b, Any N, M0; any T, Any N, M1a-b), or Stage IIIB (T1-T4a, N2-N3, M0), or subset of stage IIIA (T1-T4a, N1, M0)

Must not have

Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent

Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years into the study

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well avelumab plus copanlisib works in treating bladder cancer that has spread from its original site.

Who is the study for?

Adults over 18 with advanced bladder cancer who've finished first-line platinum-based chemo without disease progression are eligible. They must have a life expectancy of at least 3 months, controlled diabetes (A1c < 8.5%), and be able to perform daily activities with some limitations (ECOG PS ≤2 or Karnofsky ≥60%). Exclusions include recent major surgery, other cancer treatments within the last month, certain prior therapies for bladder cancer, active infections like HIV/HBV/HCV, severe allergies to monoclonal antibodies, and uncontrolled medical conditions.

What is being tested?

This trial tests copanlisib in combination with standard immunotherapy drug avelumab as maintenance therapy for patients whose metastatic bladder cancer hasn't progressed after chemotherapy. The goal is to see if this combo can help keep the cancer from advancing further.

What are the potential side effects?

Potential side effects may include immune-related reactions due to avelumab such as skin issues or organ inflammation; high blood sugar levels from copanlisib; fatigue; nausea; increased risk of infection; and possibly liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bone marrow is working well.

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My cancer is at an advanced stage but has not spread to distant organs.

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I am older than 18 years.

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I can care for myself but cannot do regular activities.

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My cancer is a type of bladder cancer that has spread or come back.

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My cancer hasn't worsened after my first chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease that could worsen with immune-boosting treatments.

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I am HIV positive or have AIDS.

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I have been treated with a PI3K inhibitor before.

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I am not pregnant or breastfeeding and willing to use 2 effective birth control methods during and 60 days after the study.

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My urothelial cancer worsened after first-line platinum-based chemotherapy.

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I have previously been treated with anti-PD1/PD-L1 for advanced breast cancer.

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I have severe symptoms from my cancer, like pain or trouble with organ function.

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I am currently on medication for an infection.

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I need steroids for my brain metastases symptoms.

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I have a lung condition or severe breathing problems.

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I have an active heart condition.

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I have a condition that causes me to bleed easily.

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I have a history of or currently have Interstitial Lung Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years into the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years into the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years into the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Adverse events

Disease-control rate

Objective response rate

+1 more

Other study objectives

Molecular Correlative Studies

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Therapeutic armExperimental Treatment2 Interventions

Copanlisib will be administered through intravenous infusion (IV) at 60 mg on Day 1, 8 and 15, and avelumab will be administered 800 mg IV on Day 1 and 15 of each 4-week treatment cycle for up to 26 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2017

Completed Phase 2

~2440

0 / 19Eligibility criteria met