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PI3K inhibitor
Copanlisib + Nivolumab + Ipilimumab for Advanced Cancers
Phase 1
Waitlist Available
Led By A P Chen
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of the drugs copanlisib and nivolumab when given together. It is also testing the side effects of copanlisib when given together with nivolumab and ipilimumab.
Who is the study for?
Adults with advanced solid tumors or lymphoma, who have tried at least one line of therapy without a cure available. They must have acceptable organ function and blood counts, not be on certain medications, agree to use contraception, and provide tissue samples for research. Excluded are those with significant illnesses or conditions like brain metastases, uncontrolled hypertension or diabetes, recent immunosuppressants use, known allergies to trial drugs, active autoimmune diseases requiring treatment within the past 3 months.Check my eligibility
What is being tested?
The trial is testing how well patients tolerate the combination of Copanlisib (blocks tumor growth proteins) and Nivolumab (boosts immune system against cancer), as well as this duo plus Ipilimumab (another immune booster). It aims to find the best dose for Copanlisib when used with these immunotherapies in treating advanced cancers and lymphomas.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), liver issues from elevated enzymes/bilirubin levels; skin reactions; endocrine disorders like thyroid dysfunction; gastrointestinal symptoms like diarrhea; fatigue; increased risk of infections due to immune suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I finished my last monoclonal antibody therapy at least 6 weeks ago, or 3 half-lives of the antibody, whichever is shorter.
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Recommended phase 2 dose of copanlisib and nivolumab combination
Other outcome measures
Biomarkers of AKT inhibition, deoxyribonucleic acid damage (gammaH2AX, pNbs1, Rad51), apoptosis, and epithelial-mesenchymal transition assessed in pre- and post- treatment tumor biopsies
Markers of anti-tumor immunity assessed in circulating immune cells, circulating tumor cells, and pre- and post-treatment tumor biopsies
Preliminary antitumor activity
Side effects data
From 2021 Phase 2 trial • 24 Patients • NCT0263159075%
Platelet count decreased
75%
Lymphocyte count decreased
71%
White blood cell decreased
71%
Fatigue
67%
Neutrophil count decreased
67%
Anemia
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Lipase increased
46%
Diarrhea
46%
Anorexia
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Hyperkalemia
25%
Constipation
25%
Vomiting
25%
Weight loss
25%
Dehydration
25%
Hypotension
25%
Rash maculo-papular
21%
Serum amylase increased
21%
Aspartate aminotransferase increased
21%
Edema limbs
17%
Creatinine increased
17%
Alkaline phosphatase increased
17%
Sinus tachycardia
17%
Chills
17%
Pain
17%
Thromboembolic event
17%
Dizziness
13%
Generalized muscle weakness
13%
Pain in extremity
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Anxiety
13%
Tinnitus
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Blood bilirubin increased
13%
Hypoalbuminemia
13%
Dyspnea
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
8%
Back pain
8%
Neck pain
8%
Depression
8%
Gallbladder obstruction
8%
Abdominal distension
8%
Ascites
8%
Bloating
8%
Dysphagia
8%
General disorders and administration site conditions -Other
8%
Cough
8%
Hypoxia
8%
Pleural effusion
8%
Pruritus
8%
Rash acneiform
8%
Infections and infestations - Other
8%
Insomnia
8%
Dysgeusia
8%
Peripheral sensory neuropathy
4%
Sore throat
4%
Cataract
4%
Lung infection
4%
Gastrointestinal disorders -Other
4%
Cholecystitis
4%
Infections and Infestations - Other
4%
Pancreatitis
4%
Toothache
4%
Stomach pain
4%
Postnasal drip
4%
Wheezing
4%
Hoarseness
4%
Hepatic infection
4%
Productive cough
4%
Nasal congestion
4%
Pneumonitis
4%
Urinary tract obstruction
4%
Bone pain
4%
Musculoskeletal and connective tissue disorders - Other
4%
Gallbladder infection
4%
Paroxysmal atrial tachycardia
4%
Pericarditis
4%
Sinus bradycardia
4%
Ear pain
4%
Dry eye
4%
Fracture
4%
Neoplasms benign, malignant and unspecified - Other
4%
Colitis
4%
Colonic obstruction
4%
Dry mouth
4%
Gastroesophageal reflux disease
4%
Infusion site extravasation
4%
Malaise
4%
Activated partial thromboplastin time prolonged
4%
Blood antidiuretic hormone abnormal
4%
Investigations - Other
4%
Urine output decreased
4%
Hypercalcemia
4%
Hypernatremia
4%
Hyperuricemia
4%
Hypokalemia
4%
Hypomagnesemia
4%
Phlebitis
4%
Aspiration
4%
Atelectasis
4%
Epistaxis
4%
Hiccups
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Skin ulceration
4%
Confusion
4%
Acute kidney injury
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
4%
Injury, poisoning and procedural complications - Other
4%
Gait disturbance
4%
Headache
4%
Parathesia
4%
Venous injury
4%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort III (Triplet) (copanlisib, nivolumab, ipilmumab)Experimental Treatment7 Interventions
Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle, nivolumab IV over 30 minutes on day 15 of cycle 1 and then day 1 of each subsequent cycles, and ipilimumab IV over 90 minutes on day 1 for cycles 2-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI throughout the trial. Patients undergo blood sample collection on study and during follow-up, as well as tumor biopsy on study. Patients also undergo an ECHO during screening and as clinically indicated on study.
Group II: Cohort II (Triplet Safety) (copanlisib, nivolumab, ipilimumab)Experimental Treatment8 Interventions
Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle, nivolumab IV over 30 minutes on day 1 of each cycle, and ipilimumab IV over 90 minutes on day 1 for cycles 1-4. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI throughout the trial. Patients undergo an ECHO during screening and as clinically indicated on study.
Group III: Cohort I (Doublet) (copanlisib, nivolumab)Experimental Treatment7 Interventions
Patients receive copanlisib IV over 1 hour on days 1 and 15 or days 1, 8, and 15 of each cycle and nivolumab IV over 30 minutes on day 1 or days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI throughout the trial. Patients undergo blood sample collection on study and during follow-up, as well as tumor biopsy on study. Patients also undergo an ECHO during screening and as clinically indicated on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
2014
Completed Phase 3
~4750
Copanlisib
2016
Completed Phase 2
~130
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,089 Total Patients Enrolled
A P ChenPrincipal InvestigatorNational Cancer Institute LAO
7 Previous Clinical Trials
526 Total Patients Enrolled
Geraldine O'Sullivan CoynePrincipal InvestigatorNational Cancer Institute LAO
4 Previous Clinical Trials
215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control during and after the study for the required time.I am HIV-positive, on stable HAART without CYP3A4 inhibitors, and have an undetectable viral load.I do not have any major health issues that would stop me from participating in the study.My blood oxygen level is above 90% at rest, and I don't have lung diseases like ILD, pneumonitis, or fibrosis.My blood pressure is consistently below 140/90 mm Hg.My diabetes is well-controlled, with blood sugar and HgA1c levels within safe limits.I have not had, nor am I planning to have, any organ or stem cell transplant.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am not taking strong CYP3A4 inhibitors or inducers.I am not taking any herbal medications except for vitamins.I am not on any anti-arrhythmic drugs except for beta blockers or digoxin.I have been screened for hepatitis B and C, and if positive, my viral load is undetectable.I have been tested for CMV within the last 28 days and my results were negative.I am allergic to certain cancer medications similar to copanlisib or nivolumab.I am 18 years old or older.I finished my last cancer treatment at least 4 weeks ago and have recovered from its side effects.I finished my last monoclonal antibody therapy at least 6 weeks ago, or 3 half-lives of the antibody, whichever is shorter.I do not have an active autoimmune disease needing strong medication in the last 3 months.I am not pregnant or breastfeeding.My cancer has spread, can't be surgically removed, and has not improved after treatment.My kidney function, measured by creatinine levels or clearance, is within the required range.I do not have active brain cancer, or it has been stable for over a month after treatment.I haven't had specific immune or gene therapies for my condition.I've had one immunotherapy but not ipilimumab + nivolumab or stopped due to serious side effects.I am on a stable dose of blood thinners like warfarin or heparin, and my blood clotting tests are within the normal range.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort III (Triplet) (copanlisib, nivolumab, ipilmumab)
- Group 2: Cohort II (Triplet Safety) (copanlisib, nivolumab, ipilimumab)
- Group 3: Cohort I (Doublet) (copanlisib, nivolumab)
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 hazardous effects does Copanlisib have on patients?
"Due to a comparative dearth of data surrounding Copanlisib's safety, our team has assigned it a score of 1 on the risk-scale. This is because this clinical trial belongs in Phase 1."
Answered by AI
Is recruitment still available for this investigation?
"The trial posted on June 29th, 2018 is not presently recruiting patients according to clinicaltrials.gov's records; the last edit was made July 2nd 2022. Nonetheless, there are currently 4742 medical studies seeking individuals for their trials."
Answered by AI
How many individuals are currently receiving treatment in this research program?
"This research project is no longer enrolling participants. It was initially posted on June 29th 2018, and the last edit to its listing occurred July 2nd 2022. There are presently 3955 trials that accept lymphoma patients and 787 clinical studies recruiting for Copanlisib involvement."
Answered by AI
What maladies does Copanlisib have the potential to alleviate?
"Copanlisib is a potential treatment for cutaneous melanoma, any prior anti-angiogenic interventions, and other malignant tumours."
Answered by AI
What other research endeavors have been made regarding Copanlisib?
"At this time, 787 trials exploring the efficacy of Copanlisib are in progress. Out of these studies, 88 have advanced to Phase 3. Most trials for this drug are located in Pittsburgh, Pennsylvania; however, there exist 43377 sites that host research into its therapeutic properties."
Answered by AI
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