Safety Study of Anti-LAG-3 in Relapsed or Refractory Hematologic Malignancies

Status:	Recruiting
Conditions:	Blood Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	11/17/2018
Start Date:	February 25, 2014
End Date:	January 15, 2020
Contact:	Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:	Clinical.Trials@bms.com

A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 (BMS-986016) in Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Relapsed or Refractory B-Cell Malignancies

The primary objective of this study is to characterize the safety, tolerability and maximum
tolerated dose of BMS-986016 administered alone or in combination with Nivolumab to subjects
with relapsed hematologic malignancies. Co-primary objective is to investigate the
preliminary efficacy of BMS-986016 in combination with nivolumab in subjects with relapsed or
refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffuse Large B Cell lymphoma
(DLBCL)

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- For dose escalation monotherapy: CLL, HL, NHL, MM

- For dose expansion monotherapy: CLL, HL, NHL

- For dose escalation and dose expansion in combination with BMS-936558: HL and DLBCL

- Progressed, or been intolerant to, at least one standard treatment regimen

- Not eligible for or declined transplantation or any standard therapy known to be life
prolonging or life saving

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- At least 1 lesion with measurable disease at baseline

- Availability of an existing tumor biopsy sample (or consent to allow pre-treatment
tumor biopsy if sample not available)

Exclusion Criteria:

- Known or suspected central nervous system (CNS) metastases or with the CNS as the only
site of active disease (controlled CNS metastases are allowed)

- Autoimmune disease

- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed
consent

- Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

We found this trial at

sites

Oregon Health and Science University

3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239

503 494-8311