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PI3K Inhibitor
Copanlisib + Immunotherapy for Lymphoma
Phase 1
Waitlist Available
Led By Tycel Philips, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ function defined as Hepatic: Total Bilirubin ≤ 1.5 mg/dL AST and ALT ≤ 2.5 x ULN. Renal: Creatinine < 2.0 mg/dl or CrCL > 30 mL/minute Bone marrow function: ANC ≥ 1000/mm3 (500/mm3 if known bone marrow (BM) involvement) Platelet ≥ 75,000/mm3 (or 50,000/mm3 if known BM involvement) Hgb > 9 g/dL (transfusions allowed to meet this criterion) Adequate glycemic control as demonstrated by a baseline fasting blood sugar (BS) ≤ 150 mg/dL. If uncontrolled then patient must be referred to PCP or endocrinology for medical management. Patient may be enrolled if adequate control is obtained prior to day 1 of therapy. Adequate blood pressure (BP) control as demonstrated by a baseline BP of < 150/90. If uncontrolled then patient must be referred to PCP for medical management. Patient may be enrolled if adequate control is obtained prior to day 1 of therapy.
ECOG Performance Status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of copanlisib, nivolumab, and rituximab in people with relapsed or refractory lymphoma.
Who is the study for?
Adults over 18 with relapsed or refractory indolent follicular or marginal zone lymphoma, who've had at least one prior therapy and are not candidates for stem cell transplantation. Participants must have adequate organ function, controlled blood sugar and blood pressure, agree to contraception if of childbearing potential, and be recovered from previous treatments.Check my eligibility
What is being tested?
The trial tests a combination of drugs (Copanlisib IV on days 1, 8, 15 every 28 days; Nivolumab IV on Cycle 1 days 1 and 15 then day 1 only; Rituximab IV on Cycle 1 days:1,8,15 &22 then day-1 C2-6) in patients with certain types of non-Hodgkin's lymphoma who have previously undergone treatment.See study design
What are the potential side effects?
Potential side effects include liver function abnormalities (e.g., elevated bilirubin), gastrointestinal issues like inflammatory bowel disease symptoms (Crohn's/ulcerative colitis), heart problems such as QT interval prolongation on ECGs indicating abnormal heart rhythms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My kidney function is within the required range.
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I cannot have or did not respond to a stem cell transplant using my own cells.
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My lymphoma has returned or didn't respond to treatment after one round of chemo-immunotherapy.
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It's been over 4 weeks since my last cancer treatment and I've recovered from major side effects.
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My liver function tests are within normal limits.
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My biopsy was analyzed and I can care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response rate of the combination of copanlisib, nivolumab, and rituximab given at the MTD.
MTD (Maximum Tolerated Dose) of copanlisib given in combination with nivolumab and rituximab
Secondary outcome measures
Duration of Response
Overall Response
Progression Free Survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Arm A: Copanlisib, Nivolumab & RituximabExperimental Treatment3 Interventions
Copanlisib IV: day 1, 8, 15 every 28 days Nivolumab IV: Cycle 1 days 1 and 15; then day 1 only Rituximab IV: Cycle 1 days 1, 8, 15, 22; then day 1 (C2-6); then Q2 cycles (8-12)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
2016
Completed Phase 2
~130
Nivolumab
2014
Completed Phase 3
~4750
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,226 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,742 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,029 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently taking, or have stopped for 2 weeks, any medications that strongly affect liver enzyme CYP3A4.I need treatment for my symptoms or meet specific health criteria.I've recovered from past treatments and it's been weeks or months since my last one.My bone marrow is working properly.I have had brain or spinal cord cancer before joining the study.It has been over 3 months since my last radio-immunotherapy session.I am 18 years old or older.My kidney function is within the required range.I have not received a live vaccine in the last 30 days.I have had a stem cell transplant from a donor.I cannot have or did not respond to a stem cell transplant using my own cells.I am a woman who could potentially become pregnant.I have vitiligo or alopecia.I have a history of inflammatory bowel disease.I do not have an active Hepatitis B or C infection.I haven't taken strong cancer drugs, immune-weakening drugs, experimental treatments, or high-dose steroids in the last month.My lymphoma has returned or didn't respond to treatment after one round of chemo-immunotherapy.I agree to use birth control or abstain from sex during and for 1 month after the study.I agree to use birth control or abstain from sex for 12 months after my last dose.My fasting blood sugar is 150 mg/dL or lower, or it's controlled with treatment.It's been over 3 months since my stem cell transplant and I've recovered from major side effects.I have been diagnosed with a specific type of lymphoma or have had a change in my cancer's behavior.I have liver issues, use a lot of acetaminophen, or have a history of liver disease.I can take care of myself but might not be able to do heavy physical work.My blood pressure is under 150/90, or I am getting it treated.I have had an autoimmune or inflammatory disorder in the last 3 years.It's been over 4 weeks since my last cancer treatment and I've recovered from major side effects.I have stable hypothyroidism on hormone replacement or psoriasis not needing systemic treatment.My liver function tests are within normal limits.I am HIV positive.My organs are working well.I do not have any serious illnesses that are not under control.I have previously been treated with PD-1/PD-L1 or PI3K inhibitors, but stopped only if I couldn't tolerate it.My biopsy was analyzed and I can care for myself.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Copanlisib, Nivolumab & Rituximab
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.
What is the aggregate enrollment tally for this investigation?
"This study requires 35 individuals, who fit the criteria of eligibility, to partake. There are two primary sites for this clinical trial; Rutgers Cancer Institute of New jersey in New Brunswick and University of Nebraska Medical Center in Omaha."
Answered by AI
What medical concerns does Copanlisib commonly address?
"Copanlisib is primarily prescribed to treat b-cell lymphomas. However, it can also be applied therapeutically for polyangium, malignant neoplasms and even unresectable melanoma."
Answered by AI
Are there still vacancies available to volunteers for this research trial?
"Confirmed, this clinical trial is recruiting participants. The study was initially announced on June 15th 2020 and has since been revised as recently as July 1st 2022."
Answered by AI
What is the aim of this clinical experiment?
"This clinical trial will assess its primary outcome, a Complete Response rate of the combination treatment, over a 28-day period. Additionally, secondary objectives including Progression Free Survival, Overall Response Rate and Duration of Response will be monitored for up to one year after initial therapy."
Answered by AI
Has any previous research explored the effects of Copanlisib?
"In the year 1993, Copanlisib was first trialled at National Institutes of Health Clinical Center. Since then, 1073 completed studies have been conducted with 1129 presently underway - a considerable number being hosted in New Brunswick, New jersey."
Answered by AI
What potential risks could arise from taking Copanlisib?
"According to our team at Power, Copanlisib has been assigned a risk score of 1 due an absence of sufficient clinical evidence regarding both efficacy and safety."
Answered by AI
How many locations in North America are currently hosting this clinical experiment?
"This medical experiment is currently taking place across 4 separate sites, including New Brunswick, Omaha and Chicago. To limit any extra travel demands associated with participation, it's recommended to select the closest trial site to your location."
Answered by AI
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