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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of study to end of study, for up to four years

Awards & highlights

Study Summary

This trial is testing if adding nivolumab to the standard of care chemotherapy can become the new first line treatment for a type of cancer called peripheral T cell lymphoma.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of study to end of study, for up to four years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of study to end of study, for up to four years

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of study to end of study, for up to four years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy: Complete Response Rate

Efficacy: Overall Response Rate

Efficacy: Partial Response Rate

+3 more

Secondary outcome measures

Correlative Analysis: Determine immune-related predictors of response to nivolumab plus EPOCH chemotherapy

Progression Free Survival (PFS)

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

Etoposide

2010

Completed Phase 3

~2440

Prednisolone

2005

Completed Phase 4

~2720

Nivolumab

2014

Completed Phase 3

~4750

Cyclophosphamide

1995

Completed Phase 3

~3770

Oncovin

2005

Completed Phase 2

~200

Hydroxydaunorubicin

2005

N/A

~160

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,742 Previous Clinical Trials

2,152,741 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,645 Previous Clinical Trials

4,130,981 Total Patients Enrolled

Brad Haverkos, MDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

EPOCH (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03586999 — Phase 1 & 2

Peripheral T-Cell Lymphoma Research Study Groups: Nivolumab and EPOCH

Peripheral T-Cell Lymphoma Clinical Trial 2023: EPOCH Highlights & Side Effects. Trial Name: NCT03586999 — Phase 1 & 2

EPOCH (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03586999 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is different about this clinical trial in comparison to others?

"Nivolumab and EPOCH have been under research for over a decade. In 2010, the first clinical trial was carried out with 127 participants. The sponsor of this initial study was Medarex. After the Phase 1 drug approval in 2010, Nivolumab and EPOCH went on to receive 747 live trials spread across 2347 cities and 50 nations."

Answered by AI

What is the standard therapy that Nivolumab and EPOCH are used to manage?

"Nivolumab in combination with EPOCH is a treatment for malignant neoplasms. This intervention can also be used to manage unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

How many individuals are being enrolled in this research project?

"This specific study is no longer recruiting patients, however, there are many other active trials that might be a match. According to our records, 1774 lymphoma trials and 747 Nivolumab/EPOCH trials are currently looking for participants."

Answered by AI

Are there any similar case studies to the one involving Nivolumab and EPOCH?

"Out of the 747 clinical trials that are currently underway and studying Nivolumab in combination with EPOCH, 82 of them are Phase 3 trials. Many of these studies originate from Basel, BE; however, there are 40324 total locations running similar investigations."

Answered by AI

Does this research study include individuals who are over the age of 60?

"The age range for participants in this clinical trial is 18 to 80 years old."

Answered by AI

If I wanted to, could I join this clinical trial?

"This lymphoma treatment clinical trial is seeking 18 participants who are aged between 18 and 80 and have been diagnosed with t-cell, peripheral cancer."

Answered by AI

Are there any positions available for participants in this trial?

"Unfortunately, this particular trial is not recruiting patients at the moment. The original posting date was November 7th 2018 and the most recent update was on August 1st 2022. Although this study isn't looking for new participants, there are 2,521 other trials that are actively searching for candidates."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

International Peripheral T-cell and Natural Killer/t-cell Lymphoma Study: Pathology Findings and Clinical Outcomes

International T-Cell Lymphoma Project. 2008. “International Peripheral T-cell and Natural Killer/t-cell Lymphoma Study: Pathology Findings and Clinical Outcomes”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2008.16.4558.

clinicaltrials.govStudy

Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas

2018. "Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03586999.

All > Peripheral T Cell Lymphoma