Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer … (NCT03502733) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma
United States64 participantsStarted 2018-08-14
Plain-language summary
This phase Ib trial studies the side effects and best dose of copanlisib and nivolumab and side effects of copanlisib given together with nivolumab and ipilimumab in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or lymphoma. Copanlisib stops tumors from growing by blocking proteins that are known to be important for tumor cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving copanlisib together with nivolumab or with nivolumab and ipilimumab may work better in treating patients with solid tumors or lymphoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with histologically documented metastatic, recurrent, or locally unresectable solid tumors which have progressed after one line of therapy, or for which no curative therapy is available. Patients with lymphoma who have received adequate exposure to standard of care therapy and for whom no curative therapy is available are also eligible (this trial will enroll a minimum of 5 lymphoma patients)
* Patients must have measurable or evaluable disease
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Leukocytes \>= 2,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL (solid tumor patients) \>= 75,000/mcL (lymphoma patients)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) /alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional ULN
* Serum creatinine =\< 1.5 x institutional ULN OR creatinine clearance \>= 50 mL/min/1.73 m\^2 by Cockcroft-Gault
* Any prior therapy must have been completed \>= 4 weeks (6 weeks for nitrosoureas and mitomycin C) or, if known, \>= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity; prior definitive radiation should have been com…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the right dose and measuring side effects rather than proving the treatment works, what does that mean for my personal safety if I were considered for something like this?
2This trial is testing three drugs together — copanlisib, nivolumab, and ipilimumab — which is a combination of a targeted therapy and two immunotherapy drugs. Can you explain how combining all three might increase the risk of serious side effects compared to taking any one of them alone?
3The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients. Are there similar Phase 1 or Phase 2 trials testing copanlisib with checkpoint inhibitors that I might be eligible for instead?
4Given that the primary goal of this trial is to establish a recommended dose and track adverse events, would my cancer type and overall health make standard treatments a safer or more beneficial first step before considering experimental combinations like this?
5If the results from this trial eventually become available, how would knowing the recommended Phase 2 dose and the types of side effects reported help guide any future treatment decisions we might consider for my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended phase 2 dose of copanlisib and nivolumab combination
Timeframe: Up to 28 days
2
Incidence of adverse events
Timeframe: Up to 30 days after the last dose of study drug