Nivolumab + Chemotherapy for Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of treatments for individuals with Hodgkin's lymphoma that has returned or did not respond to initial treatment. It tests the effectiveness of nivolumab, an immunotherapy drug that aids the immune system in attacking cancer, in combination with three chemotherapy drugs: ifosfamide, carboplatin, and etoposide. The goal is to determine if this combination can more effectively stop cancer cells from growing and spreading. Individuals with Hodgkin's lymphoma that has relapsed after initial therapy and who experience symptoms like fever, night sweats, or weight loss might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents, chemotherapy, or radiation therapy, and certain conditions requiring systemic treatments may exclude you from participation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that combining nivolumab with the chemotherapy drugs ifosfamide, carboplatin, and etoposide holds promise for treating relapsed or difficult-to-treat Hodgkin lymphoma. Early studies suggest this combination could offer hope for patients with challenging cases.
Regarding safety, previous research has examined patient responses to nivolumab, an immunotherapy that aids the immune system in attacking cancer cells. These studies indicate that nivolumab, when combined with ifosfamide, carboplatin, and etoposide, is generally well-tolerated.
However, like any treatment, side effects can occur. Similar studies have reported common side effects such as tiredness, nausea, and low blood cell counts, which are typical for chemotherapy. Monitoring these side effects is important.
This combination is currently undergoing testing in a phase 2 trial to learn more about its safety and effectiveness. Phase 2 trials aim to enhance understanding of these aspects, and any new findings will contribute to improving care for Hodgkin lymphoma patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining nivolumab with chemotherapy for Hodgkin's Lymphoma because it brings a fresh approach to treatment. Unlike most standard treatments that rely solely on chemotherapy, nivolumab is an immunotherapy drug that enhances the body's immune system to better attack cancer cells. This novel mechanism, alongside traditional chemotherapy agents like etoposide, ifosfamide, and carboplatin, aims to improve effectiveness and potentially lead to better outcomes for patients. By integrating nivolumab, these treatments could offer a new lifeline for patients, especially those who do not respond well to existing therapies.
What evidence suggests that this trial's treatments could be effective for Hodgkin's lymphoma?
Research has shown that combining nivolumab with the chemotherapy drugs ifosfamide, carboplatin, and etoposide can be very effective for patients with Hodgkin lymphoma that has returned or resisted other treatments. In this trial, participants in Cohort A and Cohort B will receive this combination. Studies have identified this combination as a strong option for these patients. In clinical trials, 73% of patients treated with this mix experienced significant tumor reduction or complete disappearance. Many patients even achieved a complete response, with all signs of cancer vanishing. Nivolumab enhances the immune system's ability to attack cancer cells, boosting the effectiveness of the chemotherapy drugs. These encouraging results offer hope for improving outcomes in challenging cases of Hodgkin lymphoma.678910
Who Is on the Research Team?
Alex F. Herrera
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab and ICE chemotherapy in cycles, with treatment adjustments based on response
Follow-up
Participants are monitored for safety and effectiveness after treatment
Post-Transplant Monitoring
Monitoring of post-autologous hematopoietic cell transplantation outcomes and complications
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Etoposide
- Ifosfamide
- Nivolumab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator