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PI3K inhibitor
Copanlisib + Nivolumab for Lymphoma
Phase 2
Waitlist Available
Led By Nabila N Bennani
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
Females who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic males do not require contraception
Patients must have a histopathologically confirmed diagnosis of diffuse large B-cell lymphoma (DBLCL) or primary mediastinal large B-cell lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5.5 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat patients with aggressive lymphoma who have either relapsed or are unresponsive to other treatments.
Who is the study for?
This trial is for adults with certain types of B-cell lymphoma that have not responded to or returned after treatment. Participants must have a specific level of blood counts, organ function, and be able to perform daily activities with minimal assistance. Pregnant women, those with recent other cancers or major treatments, active infections or severe diseases are excluded.Check my eligibility
What is being tested?
The study tests the combination of Copanlisib Hydrochloride and Nivolumab in patients with recurrent or refractory diffuse large B-cell lymphoma. It aims to see if this combo can better inhibit tumor growth by blocking enzymes needed for cell growth and boosting the immune system's ability to fight cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, increased risk of infections due to immune suppression, liver enzyme changes indicating potential liver damage, fatigue, and possibly diabetes management issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not able to have children due to menopause or surgery.
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I have been diagnosed with a specific type of lymphoma.
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My kidney function is within the required range.
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I have taken a pregnancy test with negative results within 24 hours before starting nivolumab.
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I have a tumor that is at least 1.5 cm large, visible on a CT or PET-CT scan.
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My disease did not respond to initial treatment and I cannot or have chosen not to undergo a stem cell transplant.
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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 5.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Duration of Response (DOR)
Number of Grade 3+ Adverse Events
Overall Survival Time
+1 moreOther outcome measures
Lymph3Cx Cell-of-Origin (COO) Molecular Subtyping Assay for Primary Mediastinal B Cell Lymphoma (PMBCL) and Diffuse Large B Cell Lymphoma (DLBCL) Subtypes
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (copanlisib hydrochloride, nivolumab)Experimental Treatment2 Interventions
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,655 Total Patients Enrolled
Nabila N BennaniPrincipal InvestigatorMayo Clinic Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can still have children, not sterilized, and not in menopause.I am not able to have children due to menopause or surgery.I have recovered from side effects of previous treatments, except for hair loss.I have been checked for serious gut issues before joining the study.I do not have active brain or spinal cord disease.I haven't had recent cancer treatments or major surgery before joining the study.I have been diagnosed with a high-grade B-cell lymphoma.I had a stem cell transplant less than 8 weeks ago or my blood counts haven't recovered.I am allergic to medications similar to copanlisib or nivolumab.I am not taking any herbal medications except vitamins.I have been diagnosed with a specific type of lymphoma.I have a stable autoimmune condition or vitiligo, and my diabetes is under control.I am not on high-dose steroids or strong immune system medications.I am not taking strong medication that affects liver enzymes.My kidney function is within the required range.I have taken a pregnancy test with negative results within 24 hours before starting nivolumab.I do not have any serious ongoing illnesses that could interfere with the study.I do not have an active or history of severe autoimmune disease that could worsen.I can take care of myself and am up and about more than half of my waking hours.I have not been treated with specific immune-targeting drugs but may have had CART therapy.I am not on any anti-arrhythmic drugs except for beta blockers or digoxin.I have a tumor that is at least 1.5 cm large, visible on a CT or PET-CT scan.My disease did not respond to initial treatment and I cannot or have chosen not to undergo a stem cell transplant.I haven't needed treatment for another cancer within the last 3 years.I am not pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (copanlisib hydrochloride, 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.
Has Copanlisib Hydrochloride gained the green light from the FDA?
"Copanlisib Hydrochloride is a Phase 2 medication, meaning that while there is some data showing that it is safe, there is none yet demonstrating its efficacy. Our team ranks its safety at a 2."
Answered by AI
What makes this clinical trial unique?
"Since 2010, when the first clinical trial was completed, there has been significant global interest in Copanlisib Hydrochloride. The original study, which had 127 participants, was sponsored by Medarex and resulted in Phase 1 drug approval. Currently, there are 772 live studies being conducted across 2397 cities and 56 countries."
Answered by AI
At how many hospitals or other research centers is this study being conducted?
"Patients are currently being accepted at 15 different hospitals across America, with the Salina Regional Health Center in Salina, Kansas; Huntsman Cancer Institute/University of Utah in Salt Lake City, Utah; and University of Kansas Hospital-Westwood Cancer Center in Westwood, Missouri being a few of the locations."
Answered by AI
What are the primary indications for Copanlisib Hydrochloride?
"Patients with a history of anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma can be treated using Copanlisib Hydrochloride."
Answered by AI
Are people with the specified medical condition able to enroll in this clinical trial at this time?
"Unfortunately, this study is not looking for new patients at the moment. The trial was first posted on October 19th 2018 and updated as recently as October 4th 2022. Although this particular research project isn't enrolling, there are 3,520 other ongoing studies that are presently recruiting participants."
Answered by AI
What is the scientific research landscape like for Copanlisib Hydrochloride?
"H. Lee Moffitt Cancer Center and Research Institute conducted the first study on Copanlisib Hydrochloride in 2010. There have since been a total of 267 completed clinical trials worldwide. Right now, there are 772 active studies recruiting patients; many of these studies are based out of Salina, Kansas."
Answered by AI
How many people are allowed to enroll in this research project?
"As of right now, this particular trial is not looking for any more candidates. This study was first made public on October 19th, 2018 and was edited most recently on October 4th, 2022. For individuals searching for other trials, there are presently 2748 clinical trials actively searching for participants with lymphoma and 772 trials for Copanlisib Hydrochloride that need subjects."
Answered by AI
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