Copanlisib + Nivolumab for Lymphoma

Recruiting at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Pi3 kinase inhibitors, Anti-PD-1

Disqualifiers: High grade B-cell lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well copanlisib hydrochloride and nivolumab work in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back (recurrent) or does not responded to the treatment (refractory). Copanlisib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, 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 hydrochloride and nivolumab may work better in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma compared to standard of care.

Research Team

Nabila N. Bennani

Principal Investigator

Mayo Clinic Cancer Center LAO

Eligibility Criteria

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.

Inclusion Criteria

Platelet count >= 100,000/mm^3

Hemoglobin > 9.0 g/dL

I am a woman who can still have children, not sterilized, and not in menopause.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants 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, and 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.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

Treatment Details

Interventions

• Copanlisib Hydrochloride
• Nivolumab

Trial Overview 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.

Participant Groups

Group I: Treatment (copanlisib hydrochloride, nivolumab) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+