Nivolumab and Lenalidomide in Treating Patients with Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma

Active:	No
Cancer Type:	Hodgkin Lymphoma Lymphoma Non-Hodgkin Lymphoma	NCT ID:	NCT03015896
Trial Phases:	Phase I Phase II	Protocol IDs:	OSU-16167 (primary) NCI-2016-01966 2016C0166
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Ohio State University Comprehensive Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03015896

Summary

This phase I/II trial studies the side effects and best dose of lenalidomide when given together with nivolumab and to see how well they work in treating patients with non-Hodgkin or Hodgkin lymphoma that has come back (recurrent) and does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenalidomide may stop or slow non-Hodgkin or Hodgkin lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Giving nivolumab and lenalidomide may work better than nivolumab alone in treating patients with non-Hodgkin or Hodgkin lymphoma.

Objectives

PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of the combination of lenalidomide and nivolumab in patients with relapsed/refractory non-Hodgkin lymphoma (NHL) and Hodgkin disease (HD). (Phase I)
II. To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of the combination of lenalidomide and nivolumab in patients with relapsed/refractory NHL and HD. (Phase I)
III. To evaluate the feasibility and toxicities of the combination of lenalidomide and nivolumab in patients with relapsed/refractory HD. (Phase IB)
IV. To evaluate the efficacy of the combination of lenalidomide and nivolumab in terms of overall response rate in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). (Phase II)

SECONDARY OBJECTIVES:
I. To evaluate the efficacy of the combination of lenalidomide and nivolumab in patients with relapsed/refractory NHL and HD in terms of overall response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS). (Phase I)
II. To evaluate the efficacy of the combination of lenalidomide and nivolumab in patients with relapsed/refractory HD in terms of complete response rate (CR). (Phase IB)
III. To evaluate the efficacy of the combination of lenalidomide and nivolumab in patients with relapsed/refractory HD in terms of duration of response (DOR), progression-free survival (PFS) and overall survival (OS). (Phase IB)
IV. To evaluate the efficacy of the combination of lenalidomide and nivolumab in patients with relapsed/refractory DLBCL in terms of duration of response (DOR), progression-free survival (PFS) and overall survival (OS). (Phase II)

EXPLORATORY OBJECTIVES:
I. To explore the relationship between prognostic parameters including ki-67 staining, PD-1 staining and cell of origin (activated B-cell or ABC versus germinal center B-cell or GCB) with ORR to the combination of lenalidomide and nivolumab in patients with relapsed/refractory NHL. (Phase I)
II. To evaluate and monitor effects on B-, T-, and natural killer (NK)-cell function with the combination of lenalidomide and nivolumab in patients with relapsed/refractory NHL and HD. (Phase I)
III. To explore the relationship between prognostic parameters including ki-67 staining, PD-1 staining and cell of origin (activated B-cell or ABC versus germinal center B-cell or GCB) with ORR to the combination of lenalidomide and nivolumab in patients with relapsed/refractory DLBCL. (Phase II)
IV. To evaluate and monitor effects on B-, T-, and NK-cell function with the combination of lenalidomide and nivolumab in patients with relapsed/refractory DLBCL. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.

Patients receive lenalidomide orally (PO) on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab intravenously (IV) over 60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of cycles 5-12. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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