A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,

NCT03138499 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-8122017-000847-41
• Study Type: interventional
• Target: 23
• Locations: 3 countries
• Sites: 22

Brief Summary

The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant

Conditions

Hodgkin's Disease

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method.

  From randomization to date of death, or disease progression (up to approximately 45 months)

Secondary Outcomes (5)

• Complete Response Rate (CRR):

  From randomization up to approximately 45 months

• Objective Response Rate (ORR)

  From randomization up to approximately 45 months

• Duration of Response (DOR)

  From randomization to date of documented progression or death (up to approximately 45 months)

• Duration of Complete Response (DOCR)

  From randomization to date of documented progression or death (up to approximately 45 months)

• Overall Survival (OS)

  From randomization to the date of death (up to approximately 3 years 7 months)

Study Arms (2)

Module A

EXPERIMENTAL

Nivolumab combined with Brentuximab

Biological: Nivolumab; Biological: Brentuximab vedotin

Module B

EXPERIMENTAL

Brentuximab alone

Biological: Brentuximab vedotin

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo

Module A

Brentuximab vedotin BIOLOGICAL

Specified dose on specified days

Also known as: Adcetris

Module A; Module B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following:.
• i) Autologous stem cell transplant (ASCT) ineligible patients.
• ii) Patients after failure of ASCT.
• \- Must have at least one lesion that is \> 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan.

You may not qualify if:

• Known central nervous system lymphoma.
• Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL).
• Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Seagen Inc.: collaborator
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (22)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

UCLA Clinical and Translational Research Center (CTRC)

Los Angeles, California, 90095-1678, United States

Location

Local Institution

Palo Alto, California, 94304, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

University of California San Diego

San Diego, California, 92122, United States

Location

Hartford Healthcare Cancer Institute at the Hospital of Central Connecticut

Plainville, Connecticut, 06062, United States

Location

Orlando Health, Inc

Orlando, Florida, 32806, United States

Location

Parkview Cancer Center

Fort Wayne, Indiana, 46845, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Bon Secours Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37213, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas MD Anderson Cancer Center-merge

Houston, Texas, 77030, United States

Location

Local Institution

Sendai, Miyagi, 9808574, Japan

Location

Local Institution

San Juan, 00918, Puerto Rico

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab; Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Oligopeptides; Peptides

Limitations and Caveats

Due to a treatment paradigm shift and subsequent low enrollment, the Sponsor chose to terminate the study and consequently there is limited data. These reasons were unrelated to any adverse events (AEs) or safety concerns. The sample size was smaller than expected, therefore, results should be interpreted with caution. PFS, CRR, and ORR outcomes should be interpreted with caution given large confidence intervals around medians and early study closure.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: June 26, 2017
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: January 10, 2024
• Results First Posted: April 12, 2022

Record last verified: 2024-01

Locations

US (20); PR (1); JP (1)