Trials / Suspended

SuspendedNCT03704714

Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma

Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With R-CHOP in a Cohort of Patients With DLBCL/tFL/ High Grade B-NHL

Status: Suspended
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 30 (estimated)

Sponsor: Northwestern University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of nivolumab and how well it works when giving together with combination chemotherapy in treating participants with diffuse large B-cell lymphoma. Monoclonal antibodies, such as nivolumab, interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and combination chemotherapy may work better in treating participants with diffuse large B-cell lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To identify the maximum tolerated dose (MTD) for the combination treatment of nivolumab and rituximab, cyclophosphamide, doxorubicin hydrochloride (doxorubicin), vincristine sulfate (vincristine), and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma (DLBCL). (Phase I) II. To assess the impact of nivolumab + R-CHOP on response by looking at complete response (CR) rates. (Phase II) SECONDARY OBJECTIVES: I. To look at preliminary efficacy as measured by overall response rate for combination nivolumab + R-CHOP. II. To assess the impact of nivolumab + R-CHOP on survival outcomes, specifically progression-free survival (PFS), overall survival (OS) and event-free-survival (EFS). III. To assess toxicity and tolerability of patients treated with nivolumab + R-CHOP. IV. To assess quality of life in patients treated with nivolumab + R-CHOP. EXPLORATORY OBJECTIVES: I. To explore the impact of the PD-1:PD-L1 regulatory axis and targeting this axis on the immune microenvironment. II. To identify the process of cachexia as a potential mechanism of resistance to anti-PD-1 therapy. OUTLINE: This is a phase I, dose-escalation study of nivolumab followed by a phase II study. Participants receive nivolumab intravenously (IV) over 30 minutes on day 1. Participants also receive rituximab IV on day 2, cyclophosphamide IV on day 2, doxorubicin hydrochloride IV over 3-5 hours on day 2, vincristine sulfate IV over 30 minutes on day 2, and prednisone orally (PO) on days 2-6 of course 1 and rituximab IV on day 1, cyclophosphamide IV on day 1, doxorubicin hydrochloride IV over 3-5 hours on day 1, vincristine sulfate IV over 30 minutes on day 1, and prednisone PO on days 1-5 of courses 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed for up to 18 months.

Conditions

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given IV
DRUG	Doxorubicin Hydrochloride	Given IV
BIOLOGICAL	Nivolumab	Given IV
DRUG	Prednisone	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
BIOLOGICAL	Rituximab	Given IV
DRUG	Vincristine Sulfate	Given IV

Timeline

Start date: 2018-11-20
Primary completion: 2024-12-11
Completion: 2025-06-11
First posted: 2018-10-15
Last updated: 2022-08-15

Locations

4 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03704714. Inclusion in this directory is not an endorsement.