Nivolumab for Lymphoma

Not currently recruiting at 3 trial locations

Overseen By Kelly Bumgarner, RN

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: Steven Park, MD

Must be taking: High-dose methotrexate

Must not be taking: Investigational drugs

Disqualifiers: Ophthalmologic involvement, Systemic lymphoma, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of nivolumab, an immunotherapy drug, for individuals with a specific type of brain lymphoma called PCNSL. The researchers aim to determine if nivolumab can prevent cancer recurrence after initial chemotherapy. The focus is on older patients who have completed chemotherapy and do not respond well to other treatments like whole brain radiation. Individuals who have had PCNSL, finished chemotherapy, and are unsuitable for intensive therapies might be a good fit for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this potentially groundbreaking therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that nivolumab is generally safe. For example, one study found it safe and effective for patients with Hodgkin lymphoma, demonstrating long-lasting positive results and good tolerance over five years. Another study showed that when combined with other treatments, nivolumab can significantly reduce tumor size in some patients.

Importantly, the FDA has approved nivolumab for certain types of lymphoma, indicating trust in its safety for those conditions. While side effects can occur, these studies generally indicate that the safety of nivolumab is well-understood and manageable for many patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard chemotherapy and radiation treatments for lymphoma, Nivolumab offers a unique approach by harnessing the immune system. It is an immune checkpoint inhibitor that targets the PD-1 pathway, a mechanism that tumors often exploit to evade immune detection. Researchers are excited about Nivolumab because it can potentially lead to longer-lasting remissions by enabling the immune system to better recognize and attack cancer cells. This targeted approach may also result in fewer side effects compared to traditional treatments, which can be harsh on the body.

What evidence suggests that nivolumab might be an effective treatment for lymphoma?

Research shows that nivolumab, also known as Opdivo, holds promise for treating certain types of lymphoma. In previous studies, patients with advanced Hodgkin lymphoma who received nivolumab with chemotherapy had a 92% survival rate and experienced fewer side effects. Another study found that adults with Hodgkin lymphoma who took nivolumab with a different chemotherapy treatment called AVD had an 88% chance of living without disease progression for two years, which is notably high. Additionally, some patients saw their tumors completely disappear or shrink significantly. These results suggest that nivolumab can be very effective in treating lymphoma, especially when combined with chemotherapy. Participants in this trial will receive nivolumab in different stages to further evaluate its safety and effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Steven Park, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with Primary CNS Lymphoma (PCNSL) who have already had some chemotherapy but not radiation therapy for PCNSL. They should be able to perform daily activities with varying degrees of assistance (ECOG 0-3), have CD20 positive lymphoma, and adequate organ function. Women must not be pregnant, breastfeeding, and willing to use effective contraception.

Inclusion Criteria

I am 65 years old or older.

I am considered not suitable for certain brain or stem cell treatments due to my age, physical condition, or doctor's advice.

Written informed consent and HIPAA authorization for release of personal health information of subject or subject's legally authorized representative.

Exclusion Criteria

I do not have active lung inflammation.

I have an autoimmune disease but it's under control or not expected to worsen.

Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive high-dose methotrexate containing induction chemotherapy

Varies

Nivolumab Consolidation - Stage 1

Safety evaluation of nivolumab consolidation using a 3+3 design at 480 mg every 4 weeks

Until up to 6 subjects can be adequately assessed for DLT

Nivolumab Consolidation - Stage 2

Evaluation of safety and efficacy of nivolumab consolidation in an expansion cohort

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Nivolumab

Trial Overview The trial tests Nivolumab as a follow-up treatment after initial chemotherapy in older patients with brain lymphoma. It's split into two stages: first to find a safe dose based on side effects, then to see if it helps stop the cancer from getting worse over two years compared to past data.

How Is the Trial Designed?

Group I: Stage 2 Experimental Treatment 1 Intervention

Expansion Cohort

Group II: Stage 1 Experimental Treatment 1 Intervention

Safety Run-In

Who Is Running the Clinical Trial?

Steven Park, MD

Lead Sponsor

Trials

1

Recruited

10+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/hodgkin-lymphoma-nivolumab-avd-first-line

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. opdivo.com opdivo.com/relapsed-or-progressed-chl/clinical-trial-results

Classical Hodgkin Lymphoma (cHL) | Clinical Trial Results OPDIVO · Tumors disappeared completely (complete response). 37 out of 258 people, or 14%, saw tumors disappear completely in response · Tumors shrank (partial ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7306298/

A Study of Safety and Efficacy of Nivolumab ... In this retrospective trial subsequent chemotherapy or chemotherapy-anti-PD-1 combination helped to achieve an overall response rate (ORR) of 67%. Other ...

4. pubmed.ncbi.nlm.nih.gov pubmed.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 ...

5. oncology-central.com oncology-central.com/nivolumab-improves-survival-and-reduces-long-term-side-effects-for-advanced-hodgkin-lymphoma-patients-2/

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.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1130634324001557

[Translated article] Real-world effectiveness and safety of ... Nivolumab achieved a very durable response in patients who achieved CR (79 months). Nivolumab in combination with chemotherapy rescued 2 trial patients with a ...

7. ashpublications.org ashpublications.org/bloodadvances/article/7/20/6266/497222/Nivolumab-for-relapsed-refractory-classical

5-year survival from the pivotal phase 2 CheckMate 205 study This 5-year follow-up of CheckMate 205 demonstrated favorable OS and confirmed efficacy and safety of nivolumab in R/R cHL after auto-HCT ...