Copanlisib + Nivolumab for Lymphoma

Recruiting in Duarte (>99 mi)

+3 other locations

Overseen by Alexey V Danilov

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial studies how well copanlisib and nivolumab work together in treating patients with aggressive forms of lymphoma. Copanlisib stops cancer cell growth by blocking certain enzymes, and nivolumab helps the immune system attack the cancer. The goal is to find the best dose and see how effective this combination is.

Research Team

Alexey V Danilov

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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 at least 2 treatments for my Richter's Syndrome or CLL.

Your AST and ALT levels are lower than 2.5 times the normal limit at the medical facility where you are being treated.

Exclusion 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 had a bone marrow or organ transplant from another person.

Treatment Details

Interventions

• Copanlisib (PI3K inhibitor)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Treatment (copanlisib and nivolumab) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School