Nivolumab + Chemotherapy for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Alex Herrera, M.D., Chief, Division of ...

Overseen ByAlex F. Herrera

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies the side effects of nivolumab and to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin lymphoma that has come back (relapsed) and does not respond to treatment (refractory). 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. Drugs used in chemotherapy, such as ifosfamide, carboplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab, ifosfamide, carboplatin and etoposide may work better in treating patients with Hodgkin lymphoma.

Eligibility Criteria

This trial is for patients with Hodgkin lymphoma that has returned or doesn't respond to treatment. They must have a life expectancy over 3 months, adequate blood counts, weigh more than 40 kg, and have an ECOG performance status of 0-2. Patients should be relapsed after one line of therapy or refractory to initial therapy. Exclusions include allergies to study drugs, other recent cancers or treatments, certain heart conditions, active infections including HIV/HBV/HCV, and pregnant or breastfeeding women.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

I am a man and will use birth control if I'm with a woman who can have children.

My liver function tests are within the required limits for Hodgkin lymphoma.

I weigh more than 40 kg.

My Hodgkin lymphoma has been confirmed and shows CD30 expression.

I have a tumor larger than 1.5 cm confirmed by a CT or PET scan.

Exclusion Criteria

I have never been treated with PD-1 or PD-L1 inhibitors.

I do not have any uncontrolled illnesses or active infections.

I have a history of HIV, HCV, or HBV infection.

I understand the study's purpose and risks and can give informed consent.

I finished treatment for an infection less than 14 days ago.

I have not received second-line chemotherapy for Hodgkin lymphoma.

I am receiving treatment for an active autoimmune disease.

I have active brain issues or a history of brain cancer spread.

I am willing and able to follow all study requirements.

I haven't had a heart attack in the last 6 months and don't have severe heart issues.

I do not have any severe illnesses that could risk my safety or affect the study's results.

Participant Groups

The trial tests the effectiveness and side effects of combining nivolumab (an immunotherapy drug) with chemotherapy drugs ifosfamide, carboplatin, and etoposide in those with relapsed/refractory Hodgkin lymphoma. It's a phase II study aiming to see how well this combination helps the immune system attack cancer cells and stop their growth.

2Treatment groups

Experimental Treatment

Group I: Cohort B (nivolumab, etoposide, ifosfamide, carboplatin)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Cohort A (nivolumab, etoposide, ifosfamide, carboplatin)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: