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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years into the study
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Adverse events
Disease-control rate
Objective response rate
+1 moreOther outcome measures
Molecular Correlative Studies
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
2018
Completed Phase 2
~2450
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,574 Total Patients Enrolled
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,949 Total Patients Enrolled
Chong-Xian Pan, MD PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 Previous Clinical Trials
29 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease that could worsen with immune-boosting treatments.I am HIV positive or have AIDS.You have serious ongoing health problems.I finished my first round of platinum-based chemotherapy between 4 and 10 weeks ago.My bone marrow is working well.My kidneys are working well.I am either male or female.You have hepatitis B or hepatitis C virus infection when tested before the study.My cancer is at an advanced stage but has not spread to distant organs.Your diabetes is well controlled with an A1c level less than 8.5%.My liver is working well.My high blood pressure is under control.Women who could become pregnant must have a negative pregnancy test when they are screened for the study.I have not received any vaccines within 4 weeks before starting the study treatment.I agree to use two effective birth control methods during and 60 days after the study.I don't need to show tumor shrinkage after chemotherapy.I haven't had major surgery in the last 4 weeks or major radiation in the last 2 weeks.You have had very bad reactions to monoclonal antibodies, or have a history of severe allergic reactions or uncontrolled asthma.I am a candidate for Avelumab maintenance therapy.I have been treated with a PI3K inhibitor before.I am not pregnant or breastfeeding and willing to use 2 effective birth control methods during and 60 days after the study.My urothelial cancer worsened after first-line platinum-based chemotherapy.I have previously been treated with anti-PD1/PD-L1 for advanced breast cancer.I am willing and able to follow the study's requirements.I haven't had cancer in the last 3 years, except for minor skin cancers or very early-stage cancers.I have severe symptoms from my cancer, like pain or trouble with organ function.I am currently on medication for an infection.I haven't taken immunosuppressive drugs in the last week, except for certain exceptions.I am older than 18 years.I need steroids for my brain metastases symptoms.I have a lung condition or severe breathing problems.I have an active heart condition.I have a condition that causes me to bleed easily.You have a history of not following doctor's instructions for taking medicine.Your HbA1c level is higher than 8.5% at the screening.I have a history of or currently have Interstitial Lung Disease.I can care for myself but cannot do regular activities.My cancer is a type of bladder cancer that has spread or come back.My cancer hasn't worsened after my first chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Therapeutic arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently open for this trial?
"The clinicaltrials.gov website states that this trial, which was posted on February 1st 2023 and last modified January 13th 2021, is no longer seeking participants. However, there are 415 other studies actively enrolling right now."
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