Overview

This trial was last updated 7 days ago.
Condition hodgkin disease
Treatments brentuximab vedotin, bendamustine, dacarbazine, nivolumab
Phase phase 2
Sponsor Seattle Genetics, Inc.
Collaborator Bristol-Myers Squibb
Start date October 2012
End date May 2018
Trial size 100 participants
Trial identifier NCT01716806, SGN35-015

Summary

This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as a single-agent (Part A) and in combination with dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of HL in adults age 60 and above.

Recruiting in the following locations…

United States Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Maryland, Minnesota, Nebraska, and 4 other states
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
brentuximab vedotin Adcetris; SGN-35
1.8 mg/kg every 3 weeks by IV infusion
(Experimental)
brentuximab vedotin Adcetris; SGN-35
1.8 mg/kg every 3 weeks by IV infusion
dacarbazine
375 mg/m2 every 3 weeks by IV infusion
(Experimental)
brentuximab vedotin Adcetris; SGN-35
1.8 mg/kg every 3 weeks by IV infusion
bendamustine
70 mg/m2 by IV infusion on Days 1 and 2 of 3-week cycle
(Experimental)
brentuximab vedotin Adcetris; SGN-35
1.8 mg/kg every 3 weeks by IV infusion
nivolumab
3 mg/kg every 3 weeks by IV infusion

Primary Outcomes

Measure
Objective response rate
time frame: Through 1 month following last dose

Secondary Outcomes

Measure
Incidence of adverse events
time frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only)
Incidence of laboratory abnormalities
time frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only)
Complete remission rate (CR)
time frame: Through 1 month following last dose
Duration of response
time frame: Participants will be followed for an average of 2 years
Progression-free survival
time frame: Participants will be followed for an average of 2 years
B symptom resolution rate
time frame: Through 1 month following last dose
Blood concentrations of brentuximab vedotin and metabolites
time frame: Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes
Incidence of brentuximab vedotin antitherapeutic antibodies (ATA)
time frame: Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose
Blood concentrations of nivolumab and metabolites
time frame: Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes
Incidence of nivolumab antitherapeutic antibodies (ATA)
time frame: Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma - Ineligible for or have declined initial conventional combination chemotherapy - Measurable disease of at least 1.5 cm as documented by radiographic technique - ECOG performance status less than or equal to 3 Exclusion Criteria: - Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication - Concurrent use of other investigational agents - Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug

Additional Information

Official title A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..