Phase Ib Study of Copanlisib in Combination With Nivolumab or With Nivolumab and Ipilimumab

Plain English Summary

Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma is a Phase 1 clinical trial sponsored by National Cancer Institute (NCI) studying Lymphoma, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm. This trial tests a combination of drugs (copanlisib, nivolumab, and ipilimumab) to see if they are safe and to find the best dose for treating advanced cancers and lymphoma. It is for adults with advanced or recurrent solid tumors or lymphoma that have not responded to previous treatments. Participation involves receiving the study drugs, regular medical check-ups, blood tests, and possibly biopsies. Alternative treatments may include chemotherapy, radiation, or other targeted therapies, depending on the specific cancer. The trial aims to enroll 64 participants.

Official 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

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with specific types of advanced or recurrent solid tumors or lymphoma. Patients must have disease that has progressed after at least one prior treatment, or for which no cure is available. Individuals must have a good general health status (ECOG performance status of 0 or 1) and adequate blood counts. Patients with brain metastases or meningitis are generally excluded, unless their condition is stable after treatment. This trial is studying Lymphoma, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures will help determine the safest dose of the drug combination and identify any side effects, which is crucial for understanding how well the treatment might work and if it's The specific primary outcome measures are: Recommended phase 2 dose of copanlisib and nivolumab combination (Up to 28 days); Incidence of adverse events (Up to 30 days after the last dose of study drug). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial is important because it explores new drug combinations that could offer better treatment options for patients with advanced cancers and lymphoma who have limited alternatives. This research targets Lymphoma, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, where improved treatment options are needed.

Investor Insight

This trial investigates novel combination therapies in oncology, a rapidly growing market. Success could lead to new treatment standards for difficult-to-treat cancers, signaling a potentially valuabl Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific drugs being tested, potential side effects, and how this trial compares to standard treatments. Be prepared for regular clinic visits for drug administration, blood draws, scans, and potential biopsies. Understand that you will need to use effective birth control during and after the trial if you are of childbearing potential. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 64 participants

Interventions

• PROCEDURE: Biopsy Procedure — Undergo tumor biopsy
• PROCEDURE: Biospecimen Collection — Undergo blood sample collection
• PROCEDURE: Computed Tomography — Undergo CT scan
• DRUG: Copanlisib — Given IV
• PROCEDURE: Echocardiography Test — Undergo ECHO

Primary Outcomes

• Recommended phase 2 dose of copanlisib and nivolumab combination (Up to 28 days)
• Incidence of adverse events (Up to 30 days after the last dose of study drug)

Full Eligibility Criteria

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 completed \>= 4 weeks or palliative radiation should have been completed \>= 2 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the principal investigator's \[PI's\] discretion); patients must be \>= 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) at the PI's discretion, and should have recovered to grade 1 or baseline from any toxicities
* 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)
* Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that their medication dose is stable, and international normalized ratio/partial thromboplastin time (INR/PTT) remains stable within the recommended therapeutic range
* Patients must have left ventricular ejection fraction (LVEF) \>= 50%
* The effects of nivolumab, copanlisib and ipilimumab on the developing human fetus are unknown, and there is potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the treatment portion of the study, and for a minimum of 5 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to study entry, for the duration of study participation, and for 7 months after completion of study treatment
* Ability to understand and the willingness to sign a written informed consent document
* Willingness to provide blood for research purposes (all patients, apart from patients enrolled onto triplet safety run-in phase) and willingness to provide new tumor biopsy samples for research purposes (doublet and triplet expansion cohorts)

Exclusion Criteria:

* Patients who are receiving any other investigational agents
* Patients with clinically significant illnesses which would compromise participation in the study, including but not limited to active or uncontrolled infection, immune deficiencies, hepatitis B, hepatitis C, active tuberculosis, uncontrolled asthma, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, myocardial infarction within the past 6 months, cerebral vascular accident/stroke within the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for \>= 1 month after treatment of the brain metastases; patients on anti-seizure medications may be enrolled at the discretion of the principal investigator
* Patients with blood oxygen saturation \< 90% at rest; patients must not have symptomatic interstitial lung disease, pneumonitis, or known pulmonary fibrosis. Patie

Trial Locations

• National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland, United States
• National Institutes of Health Clinical Center, Bethesda, Maryland, United States
• M D Anderson Cancer Center, Houston, Texas, United States

Frequently Asked Questions

Related Conditions

• Lymphoma
• Solid Tumors
• Metastatic Cancer
• Recurrent Cancer
• Unresectable Cancer
• Oncology
• Immunotherapy
• Targeted Therapy
• Cancer Drug Combinations
• Hematologic Malignancies

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