NCT02541565

Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Diffuse Large B-cell Lymphoma or Grade 3b Follicular Lymphoma

MK-3475 in Combination With Standard RCHOP Therapy for Previously Untreated Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I trial studies the side effects of pembrolizumab and combination chemotherapy in treating patients with previously untreated diffuse large B-cell lymphoma or grade 3b follicular lymphoma. Monoclonal antibodies, such as pembrolizumab and rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, 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 pembrolizumab together with combination chemotherapy may be with a better treatment for diffuse large B-cell lymphoma or follicular lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To measure the toxicity profile of pembrolizumab (MK-3475) when co-administered with full-course RCHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone) in subjects with previously untreated diffuse large B-cell lymphoma (DLBCL). SECONDARY OBJECTIVES: I. To assess clinical outcomes including response rate, event-free survival, and overall survival after MK-3475 + RCHOP induction for subjects with previously untreated DLBCL. TERTIARY OBJECTIVES: I. To measure baseline expression of proteins in the programmed death-1 (PD-1) family on tumor cells and coexisting immune infiltrates, using archival tissue when available. II. To measure peripheral blood T cell subsets before and after treatment using flow cytometry, and to measure baseline vitamin D (25-hydroxy, total). III. To explore relationships with these parameters and likelihood of response to therapy and outcomes. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and prednisone orally (PO) on days 1-5. Patients also receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 2 of course 1 and on day 1 of subsequent courses. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of the study treatment, patients are followed up to 5 years.

Conditions

• Composite Lymphoma
• Grade 3b Follicular Lymphoma
• Stage I Diffuse Large B-Cell Lymphoma
• Stage I Follicular Lymphoma
• Stage II Diffuse Large B-Cell Lymphoma
• Stage II Follicular Lymphoma
• Stage III Diffuse Large B-Cell Lymphoma
• Stage III Follicular Lymphoma
• Stage IV Diffuse Large B-Cell Lymphoma
• Stage IV Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given IV
DRUG	Doxorubicin Hydrochloride	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Prednisone	Given PO
BIOLOGICAL	Rituximab	Given IV
DRUG	Vincristine Sulfate	Given IV

Timeline

• Start date: 2015-11-24
• Primary completion: 2018-12-18
• Completion: 2018-12-18
• First posted: 2015-09-04
• Last updated: 2020-10-14
• Results posted: 2020-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study