Nivolumab + Chemotherapy for Hodgkin's Lymphoma

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

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: 3

Duration: Up to 6 months

78 Participants Needed

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.

Research Team

Alex F. Herrera

Principal Investigator

City of Hope Medical Center

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 am following the required birth control measures.

Total bilirubin must be within 1.5 x the upper limit of normal (ULN) institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible

Diffusion capacity of the lung for carbon monoxide (DLCO) must be >= 60%

Exclusion Criteria

I haven't had chemotherapy or radiation in the last 3 weeks and have recovered from any side effects.

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

I do not have any uncontrolled illnesses or active infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive nivolumab and ICE chemotherapy in cycles, with treatment adjustments based on response

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 3 months

Post-Transplant Monitoring

Monitoring of post-autologous hematopoietic cell transplantation outcomes and complications

Up to 3 years

Treatment Details

Interventions

• Carboplatin
• Etoposide
• Ifosfamide
• Nivolumab

Trial Overview 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.

Participant Groups

Group I: Cohort B (nivolumab, etoposide, ifosfamide, carboplatin) Experimental Treatment 5 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 Treatment 5 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:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+