Nivolumab + Chemotherapy for Hodgkin's Lymphoma

Not currently recruiting at 3 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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

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

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%
See 16 more

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.
See 17 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort B (nivolumab, etoposide, ifosfamide, carboplatin)Experimental Treatment5 Interventions
Group II: Cohort A (nivolumab, etoposide, ifosfamide, carboplatin)Experimental Treatment5 Interventions

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

🇺🇸
Approved in United States as Paraplatin for:
🇪🇺
Approved in European Union as Carboplatin for:
🇨🇦
Approved in Canada as Carboplatin for:

Find a Clinic Near You

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+

Citations

Nivolumab and AVD the New Standard in Hodgkin ...The 2-year progression-free survival rate of 88% among those in this age group treated with nivolumab–AVD “is probably the best ever reported,” ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39413375/
Nivolumab+AVD in Advanced-Stage Classic Hodgkin's ...Conclusions: N+AVD resulted in longer progression-free survival than BV+AVD in adolescents and adults with stage III or IV advanced-stage ...
[Translated article] Real-world effectiveness and safety of ...Complete response was achieved by 3 patients (23.1%), partial response by 3 (23.1%), stable disease by 3 (23.1%), and progression by 4 (30.8%). The objective ...
Nivolumab plus chemotherapy yields 92% survival rate for ...Advanced Hodgkin lymphoma patients who received chemotherapy alongside Opdivo (nivolumab) had a 92% survival rate and fewer side effects.
Classical Hodgkin Lymphoma (cHL) | Clinical Trial ResultsOPDIVO · Tumors disappeared completely (complete response). 6 out of 95 people, or 6%, saw tumors disappear completely in response · Tumors shrank (partial ...
Nivolumab plus ifosfamide, carboplatin, and etoposide are ...Nivolumab plus ifosfamide, carboplatin, and etoposide are a highly effective first salvage regimen in high‐risk relapsed/refractory Hodgkin lymphoma.
Study Details | Nivolumab, Ifosfamide, Carboplatin, and ...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 ...
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40313510/
Nivolumab plus ifosfamide, carboplatin, and etoposide are a ...Nivolumab plus ifosfamide, carboplatin, and etoposide are a highly effective first salvage regimen in high-risk relapsed/refractory Hodgkin ...
Has PD-1 blockade changed the standard of care for cHL?PD-1 inhibitors have demonstrated high efficacy in patients with Hodgkin lymphoma, including one of the highest objective response rates for this class of drug.
Nivolumab plus ifosfamide, carboplatin, and etoposide are ...Nivolumab plus ifosfamide, carboplatin, and etoposide are a highly effective first salvage regimen in high‐risk relapsed/refractory Hodgkin ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security