What side effects are associated with this type of intervention?

Common treatments for Peripheral T-Cell Lymphoma, particularly those involving immune checkpoint inhibitors like Nivolumab, are associated with a range of side effects. Nivolumab can cause immune-related adverse events including rash, pruritus, diarrhea, colitis, hypothyroidism, pneumonitis, and myocarditis. When combined with standard chemotherapy, additional side effects such as neutropenia, anemia, and thrombocytopenia may occur. These side effects reflect the immune-modulating nature of Nivolumab and the cytotoxic effects of chemotherapy.

What prior FDA approvals exist?

For the treatment of Peripheral T-Cell Lymphoma (PTCL), the FDA has approved several drugs, including brentuximab vedotin, which targets CD30, and pralatrexate, a folate analog metabolic inhibitor. While these drugs are not PD-1 inhibitors, they represent significant advancements in PTCL treatment. Currently, Nivolumab, a PD-1 inhibitor, is being studied in combination with standard chemotherapy for PTCL, aiming to enhance treatment efficacy by leveraging the immune system's ability to target cancer cells.

What other types of research exist?

Promising novel alternatives to Nivolumab for PTCL patients include other immune checkpoint inhibitors such as Pembrolizumab (PD-1 inhibition) and Avelumab (PD-L1 inhibition). Additionally, experimental approaches like Chimeric Antigen Receptor (CAR)-T cell therapies are being tested and show potential. Patients should consider enrolling in clinical trials for these new strategies.

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Anti-tumor antibiotic

Nivolumab + Chemotherapy for Peripheral T-Cell Lymphoma

Phase 1 & 2

Waitlist Available

Led By Brad Haverkos, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0 - 2

Histologically confirmed new diagnosis of Stage II, III or IV Peripheral T-cell Non-Hodgkin's lymphoma not otherwise specified (NOS), Anaplastic large cell lymphoma (ALK-negative) (ALK-positive if IPI 3, 4, or 5), Angioimmunoblastic T-cell lymphoma, Enteropathy associated T-cell lymphoma (MEITL and EATL), Hepatosplenic T-cell lymphoma, y/8 T-cell lymphoma, Subcutaneous panniculitis-like T-cell lymphoma, and Nodal T-cell lymphomas with T-follicular helper phenotype

Must not have

History of non-infectious pneumonitis requiring immuno-suppressive therapy

Patients with a diagnosis of other PTCL histologies other than those specified in the inclusion criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 months of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for peripheral T cell lymphoma using nivolumab and standard chemotherapy. Nivolumab helps the immune system fight cancer, and chemotherapy kills cancer cells. Nivolumab has shown benefits in various cancers by improving survival rates and is often used in combination with other treatments.

Who is the study for?

Adults over 18 with certain types of Peripheral T-cell Non-Hodgkin's lymphoma, stages II-IV, who can sign consent and follow the study plan. They should have adequate organ function and no prior significant treatments except possibly one chemotherapy cycle or radiation. Pregnant women, those with other recent cancers or autoimmune diseases needing treatment, active hepatitis B/C or HIV are excluded.

What is being tested?

The trial is testing Nivolumab combined with standard chemotherapy drugs (Prednisolone, Cyclophosphamide, Etoposide, Oncovin [Vincristine], Hydroxydaunorubicin) to see if it's effective as a first-line treatment for peripheral T cell lymphomas.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs like the lungs (pneumonitis), liver issues from elevated enzymes/bilirubin levels in blood tests; fatigue; increased risk of infections due to lowered white blood cells; nausea; hair loss from chemo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than 50% of my waking hours.

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I have been diagnosed with a specific type of advanced T-cell lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had lung inflammation treated with immune-suppressing drugs.

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My cancer type is not listed in the trial's specified types.

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I have previously received PD-1 or PD-L1 antibody treatment.

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I am allergic or cannot take certain medications needed for the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days after last dose of nivolumab

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days after last dose of nivolumab

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days after last dose of nivolumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy: Complete Response Rate

Secondary study objectives

Efficacy: Event Free Survival

Efficacy: Overall Response Rate

Efficacy: Progression Free Survival Rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nivolumab and EPOCHExperimental Treatment6 Interventions

Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oncovin

2005

Completed Phase 2

~220

Nivolumab

2015

Completed Phase 3

~4010

Etoposide

2010

Completed Phase 3

~2960

Prednisolone

2005

Completed Phase 4

~3570

Cyclophosphamide

2010

Completed Phase 4

~2310

Hydroxydaunorubicin

2005

Completed Phase 2

~180

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral T-Cell Lymphoma (PTCL) treatments often include immunotherapy and chemotherapy. Nivolumab, a PD-1 inhibitor, works by blocking the PD-1 protein on T cells, preventing cancer cells from evading the immune response, thus enhancing the body's ability to fight the cancer. This is crucial for PTCL patients as it offers a targeted approach that can be more effective and potentially less toxic than traditional chemotherapy. Other treatments may include combination chemotherapy, which aims to kill rapidly dividing cancer cells but can have significant side effects. The emphasis on immunotherapy, like Nivolumab, represents a shift towards treatments that harness the patient's immune system to combat the lymphoma more effectively.

Cancer-targeted photoimmunotherapy induces antitumor immunity and can be augmented by anti-PD-1 therapy for durable anticancer responses in an immunologically active murine tumor model.Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Ipilimumab pharmacotherapy in patients with metastatic melanoma.