A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT02220842
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    During safety evaluation stage, atezolizumab will be administered as 1200 milligrams (mg) intravenous (IV) infusion. During expansion stage, atezolizumab will be administered as either 1200 mg IV infusion or at dose decided from safety evaluation stage.
  • Obinutuzumab — DRUG
    During safety evaluation stage, obinutuzumab will be administered as 1000 mg IV infusion. During expansion stage, obinutuzumab will be administered as either 1000 mg IV infusion or at dose decided from safety evaluation stage.
  • Tazemetostat — DRUG
    Tazemetostat 800 mg will be administered orally, twice daily, on Days 1 to 21.

Study Details

This open-label, multicenter, global study is designed to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and obinutuzumab in participants with refractory or relapsed follicular lymphoma (FL) or atezolizumab and obinutuzumab or tazemetostat administered in participants with refractory or relapsed diffuse large B-cell lymphoma (DLBCL). The anticipated duration of this study is approximately 4.5 years.

Key Dates

Start date
Dec 18, 2014
Status verified
Jan 2020
Primary completion
Jan 21, 2020
Completion
Jan 21, 2020

Study Design

Enrollment
96 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 Cohort A (Safety Evaluation):Atezolizumab + Obinutuzumab
    Relapsed/refractory FL and DLBCL participants will receive obinutuzumab alone on Days 1, 8, and 15 of Cycle 1 (Cycle length = 21 days), followed by atezolizumab and obinutuzumab on Day 1 of Cycles 2-8, and then atezolizumab alone on Day 1 of Cycle 9 and every cycle thereafter until unacceptable toxicities or disease progression.
  • Experimental: Arm 1 Cohort B (Expansion): Atezolizumab + Obinutuzumab
    Relapsed/refractory FL participants will receive atezolizumab and obinutuzumab as per schedule and dose decided from the safety evaluation stage, until unacceptable toxicities or disease progression.
  • Experimental: Arm 1 Cohort C (Expansion): Atezolizumab + Obinutuzumab
    Relapsed/refractory DLBCL participants will receive atezolizumab and obinutuzumab as per schedule and dose decided from the safety evaluation stage, until unacceptable toxicities or disease progression.
  • Experimental: Arm 2 Cohort D (Safety Evaluation):Atezolizumab + Tazemetostat
    Relapsed/refractory DLBCL participants will receive atezolizumab (on Day 1) and tazemetostat (on Days 1-21) of each 21-day cycle until unacceptable toxicities or disease progression.
  • Experimental: Arm 2 Cohort E (Expansion): Atezolizumab + Tazemetostat
    Relapsed/refractory DLBCL participants will receive atezolizumab and tazemetostat as per schedule and dose decided from the safety evaluation stage, until unacceptable toxicities or disease progression.

Primary Outcome Measure

Percentage of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days (for Arm 1: Days 1 to 21 to Cycle 2; for Arm 2: Days 1 to 21 of Cycle 1, cycle length = 21 days) ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Fort Wayne Neurological CenterFort WayneIndiana46805-
Hackensack University Medical CenterHackensackNew Jersey07601-
Sloan Kettering Cancer CenterNew YorkNew York10065-6007-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
MD Anderson Cancer CenterHoustonTexas77030-
UW- Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAFort Wayne Neurological Center· Fort Wayne, INHackensack University Medical Center· Hackensack, NJSloan Kettering Cancer Center· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NCMD Anderson Cancer Center· Houston, TX

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