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A Study of Atezolizumab in Combination With an Immunotherapy Agent Investigated With or Without Anti-Cd20 Therapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

NCT03369964 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-04-05

No results posted yet for this study

Summary

This study will investigate the safety, pharmacology, and activity of atezolizumab in combination with immunotherapy agents with or without an anti-CD20 agent (i.e., obinutuzumab) in patients with relapsed or refractory (R/R) follicular lymphoma (FL). The first immunotherapy molecule investigated will be emactuzumab (Arm A) in two combinations.

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Atezolizumab

In Cohort A1, Atezolizumab will be administered, 1200 mg IV, every 3 weeks starting on Cycle 2; Day 1 of a 21 day cycle In Cohort A2, Atezolizumab will be administered, 1200 mg IV, starting on Cycle 2; Day 1 of a 21 day cycle In Cohort A2 , In Cycle 2-8, Atezolizumab will be administered, 1200 mg IV on day 1 of each 21 day cycle In Cohort A2, Atezolizumab will be administered, 1200 mg IV starting on Cycle 9; Day 1 of each 21 day cycle

DRUG

Emactuzumab

In Cohort A1, Emactuzumab will be administered 1000 mg IV, every 3 weeks, starting on Cycle 1; Day 1 of a 21 day cycle. In Cohort A2, Emactuzumab will be administered 1000 mg IV, starting on Cycle 1 Day 1 of a 21 day cycle. In Cohort A2, in cycle 2-8, Emactuzumab will be administered 1000 mg IV, on day 1 of each 21 day cycle. In Cohort A2, Emactuzumab will be administered 1000 mg IV starting on Cycle 9; on Day 1 of each 21 day cycle

DRUG

Obinutuzumab

In Cohort A2, Obinutuzumab will be administered 1000 mg IV starting on Cycle 1; Day 1 of a 21 day cycle In Cohort A2, Obinutuzumab will be administered again on days 8 and 15 (Cycle 1) of a 21 day cycle In Cohort A2, in cycle 2-8, Obinutuzumab will be administered 1000 mg IV on day 1 of each 21 day cycle

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2018-12-31
Completion
2019-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369964 on ClinicalTrials.gov