Phase 2 N=144 Treatment

An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas

Non-Hodgkin's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02581631 ↗

Enrolled (actual)

144

Serious AEs

57.6%

Results posted

Mar 2023

Primary outcome: Primary: Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase — 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Nivolumab (Biological); Brentuximab Vedotin (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase	0; 0; 0	—
PRIMARY Safety Analysis - Number of Participant Deaths	24; 22; 3; 3; 5	—
PRIMARY Safety Analysis - Number of Participants With Adverse Advents	42; 33; 29; 10; 30	—
PRIMARY Safety Analysis - Number of Participants With Serious Adverse Events	22; 19; 14; 4; 10	—
PRIMARY Safety Analysis - Number of Participants With Adverse Events Leading to Discontinuation	11; 10; 6; 2; 8	—
PRIMARY Safety Analysis - Number of Participants With Adverse Events Leading to Dose Delay or Reduction	16; 15; 14; 3; 17	—
PRIMARY Safety Analysis - Number of Participants With Drug Related Adverse Events	35; 27; 25; 9; 25	—
PRIMARY Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities	34.6; 29.6; 18.2; 11.1; 24.0; 26.9	—
PRIMARY Safety Analysis - Percentage of Participants With Liver Test Abnormalities	4.8; 6.1; 13.8; 20.0; 24.0; 2.4	—
PRIMARY Objective Response Rate (ORR)	28.6; 45.5; 41.4; 70.0; 73.3	—
SECONDARY Duration of Response (DOR)	3.55; 4.60; 26.97; 20.76; NA	—
SECONDARY Complete Response Rate (CRR)	7.1; 33.3; 3.4; 50.0; 40.0	—
SECONDARY Duration of Complete Response	36.53; 7.39; NA; NA; NA	—
SECONDARY Progression Free Survival (PFS)	2.60; 4.30; 15.61; 21.88; 25.95	—
SECONDARY Overall Survival (OS)	13.31; 11.07; 37.16; NA; NA	—

Summary

The purpose of this study is to determine whether Nivolumab, in combination with brentuximab vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas with CD30 expression that have not responded to treatment or have come back. The subtypes we are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and Mediastinal Gray Zone Lymphoma (MGZL).

Eligibility Criteria

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

Inclusion Criteria

Relapsed/refractory diffuse large B cell lymphoma (DLBCL), relapsed/refractory peripheral T cell lymphoma (PTCL) (all subtypes excluding anaplastic large cell lymphoma), relapsed/refractory Cutaneous T cell lymphoma (CTCL) mycosis fungoides/sezary syndrome (MF/SS), relapsed/refractory primary mediastinal B lymphoma (PMBL), and relapsed/refractory mediastinal gray zone lymphoma (MGZL)
Expression of CD30
Subjects must be 18 years or older (≥ 15 years for PMBL)

Exclusion Criteria

Known central nervous system (CNS) lymphomas; Active cerebral/meningeal disease related to the underlying malignancy
Active, known, or suspected autoimmune disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02581631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.