Your session is about to expire
← Back to Search
PI3K inhibitor
Copanlisib + Nivolumab for Lymphoma
Phase 1
Waitlist Available
Led By Alexey Danilov, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
Estimated creatinine clearance (CrCL) using the Cockroft-Gault equation >= 30 mL/min.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks
Awards & highlights
Study Summary
This trial is testing copanlisib + nivolumab to see if it's an effective treatment for Richter's transformation or transformed indolent non-Hodgkin lymphoma.
Who is the study for?
This trial is for patients with Richter's transformation or transformed indolent non-Hodgkin lymphoma who've had at least one prior treatment. Participants must have measurable disease, acceptable organ function, and agree to contraception if applicable. Exclusions include pregnancy, uncontrolled health conditions like hypertension or bleeding disorders, recent major surgery, live vaccines, certain heart issues, and previous treatments with similar drugs.Check my eligibility
What is being tested?
The trial tests the combination of copanlisib (blocks enzymes for cell growth) and nivolumab (boosts immune system against cancer). It aims to find the best dose and see how well these drugs work together in treating specific types of lymphoma by stopping tumor growth and helping the body attack cancer cells.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from drug administration into a vein, fatigue from energy depletion due to treatment effects on normal cells as well as cancerous ones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My kidneys are functioning well enough for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks
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
Incidence of dose-limiting toxicities of copanlisib in combination with nivolumab
Secondary outcome measures
Duration of response
Heart rate
Progression-free survival (PFS)
Other outcome measures
Evaluation of T-cell repertoire of patients with transformed chronic lymphocytic leukemia (CLL)/non-Hodgkin's lymphoma (NHL) after receiving nivolumab
Tumor response
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
1Treatment groups
Experimental Treatment
Group I: Treatment (copanlisib and nivolumab)Experimental Treatment2 Interventions
Patients receive copanlisib IV over 60 minutes on days 1, 8, and 15 and nivolumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles 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
Copanlisib
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,433 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,126 Total Patients Enrolled
Alexey Danilov, MDPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatments like antibodies, radiation, or chemotherapy recently.My cancer has spread to my brain or spinal cord.I have lymphoma, have tried at least one treatment without success, and am not planning or eligible for a stem cell transplant.I have had a bone marrow or organ transplant from another person.I have not had major surgery in the last 30 days.You have a current or suspected autoimmune disease.I do not have an uncontrolled bleeding disorder.I have not received a live vaccine in the last 30 days.I do not have severe heart issues like recent heart attacks or very weak heart pumping.I have had at least 2 treatments for my Richter's Syndrome or CLL.You currently have hepatitis B or C, or had hepatitis C in the past.I have a history of HIV.Your AST and ALT levels are lower than 2.5 times the normal limit at the medical facility where you are being treated.I am a male willing to use contraception or practice abstinence during and for 1 month after the study.I haven't taken immune checkpoint inhibitors in the last 2 years, except for treating Richter syndrome.I haven't taken strong CYP3A4 inhibitors or inducers in the last 2 weeks.My high blood pressure is not controlled, even with medication.I do not have uncontrolled immune-related blood disorders.I take more than 15 mg of prednisone daily.All my side effects from previous treatments are mild, except for hair loss and nerve pain.Your total bilirubin level should be within two times the normal range set by the hospital.I am a woman not able to have children, or I will use two forms of birth control or practice abstinence.I can take care of myself and am up and about more than half of my waking hours.I had cancer before, but it's been treated and inactive for over 2 years, or it was a minor skin cancer or in situ carcinoma without current signs of disease, or I have asymptomatic prostate cancer not requiring immediate treatment.My platelet count is above 75,000/mm^3, or above 25,000/mm^3 due to bone marrow involvement.I am not pregnant or nursing.My cancer has changed into a more aggressive form known as DLBCL.Your HbA1c level is higher than 8.5%.Your lymph nodes or other body tissues show visible changes on imaging.Your body has enough infection-fighting white blood cells.I have a lung condition that affects my breathing.My kidneys are functioning well enough for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (copanlisib and 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.
Can you explain what treatments Copanlisib is typically prescribed for?
"Copanlisib is primarily used to treat those who have undergone anti-angiogenic therapy, but it may also be administered for malignant neoplasms, unresectable melanomas, and squamous cell carcinoma."
Answered by AI
Is enrollment for this investigation ongoing?
"As per the clinicaltrials.gov entry, this clinical trial is still enlisting participants for participation and study. It was initially posted on February 26th 2019, with its most recent update taking place on March 9th 2022."
Answered by AI
What is the aggregate amount of participants engaged in this experiment?
"Affirmative. Clinicaltrials.gov data affirms that this research is presently seeking enrollees; the project was first published on February 26th 2019 and last updated on March 9th 2022, with a goal of enlisting 21 participants across three separate sites."
Answered by AI
What aims are being pursued in this research endeavor?
"Over a timeframe of up to 28 days, this trial will assess the frequency of adverse events according to CTCAE v5. Secondary objectives include evaluation of overall survival with Kaplan-Meier estimates and 95% confidence intervals; duration of response through means and standard deviation with 95% confidence intervals; and progression-free survival via Kaplan-Meier estimations supplemented by subset analysis in patients treated at maximum tolerated dose (MTD)."
Answered by AI
Could you elucidate the potential perils of taking Copanlisib?
"Our team has assigned Copanlisib a score of 1 on the safety scale, as it is still in Phase 1 trials where limited data exists regarding its effectiveness and security."
Answered by AI
Has a trial like this ever been conducted previously?
"Globally, there are 740 active trials for Copanlisib occurring in 55 countries and 2406 cities. This drug was first tested back in 2012 by Ono Pharmaceutical Co. Ltd., involving 659 patients and achieving Phase 1 & 2 approval status. Since then, 270 additional studies have been completed successfully."
Answered by AI
Can you outline any preceding investigations into Copanlisib?
"Presently, there are 740 Copanlisib clinical trials in progress with 84 of the studies being held at their final stage. Basel is just one locale among 40906 around the world conducting research on Copanlisib's efficacy."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger