Nivolumab for Lymphoma

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

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of Stage 1 is to evaluate the safety of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in older subjects with PCNSL in terms of a tolerated dose (based on dose-limiting toxicities) for the expansion phase of the study (Stage 2).The primary objective of Stage 2 is to evaluate the efficacy of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in terms of the 2-year progression-free survival rate and compare to relevant historical controls

Research Team

Steven Park, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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