A Study of RO7082859 in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Non-Hodgkin Lymphomas

Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:March 13, 2018
End Date:June 17, 2023
Contact:Reference Study ID: NP40126 www.roche.com/about_roche/roche_worldwide.htm
Phone:888-662-6728 (U.S. only)

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A Phase 1B Study Evaluating RO7082859 in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

This is a phase 1B, multi-center, dose-finding study of RO7082859 administered in combination
with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G/R-CHOP or
R-CHOP) in participants with r/r NHL and untreated diffuse large B-cell lymphoma (DLBCL).
Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic
effects of this combination will be the main objectives of this study. The study is divided
in two parts:

- Part I: Dose finding in participants with r/r NHL

- Part II: Dose expansion in which the maximum tolerated dose (MTD) (or optimal biologic
dose [OBD]) determined in Part I will be further assessed in participants with r/r NHL
and those with untreated DLBCL (>60 years old with an age-adjusted International
Prognostic Index [IPI]) of 2-3), and the impact of using G in place of R in Cycle 1 on
safety and tolerability will be assessed via a randomized, unblinded, two-arm design in
participants with untreated DLBCL.

Inclusion Criteria:

- Age>/=18 years for participants with r/r NHL or > 60 years for participants with
untreated DLBCL

- For Part I r/r NHL dose-escalation, and Part II r/r NHL expansion:
Histologically-confirmed NHL that is expected to express CD20, and which has
relapsed/progressed following at least one prior treatment regimen containing R or G.
Participants must be appropriate for treatment with CHOP and typically should not have
been exposed to prior anthracyclines or must not exceed the cumulative lifetime dose
of anthracyclines

- For Part II untreated DLBCL expansion: Histologically confirmed previously-untreated
DLBCL that is expected to express CD20

- Able to provide a pretreatment biopsy between the last dose of last prior therapy and
initiation of study medication at Cycle 1/Day 1

- Participants must have at least one measurable target lesion (> or = 1.5 cm) in its
largest dimension by computed tomography (CT) scan

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for
participants with r/r NHL; ECOG performance status 0-3 for participants with untreated

- Life expectancy (in the opinion of the Investigator) of 18 weeks

- Adverse events (AEs) from prior anti-cancer therapy must have resolved to Grade < or =

- Adequate liver function

- Adequate hematological function

- Adequate renal function

- Negative serologic or polymerase chain reaction (PCR) test results for acute or
chronic hepatitis B virus (HBV) infection

- Negative test results for hepatitis C virus (HCV) and human immunodeficiency virus

Exclusion Criteria:

- Inability to comply with protocol mandated hospitalization and restrictions

- Participants with known active infection, or reactivation of a latent infection,
whether bacterial, viral (including, but not limited to Epstein Barr virus (EBV), HBV,
HCV, and HIV), fungal, mycobacterial, or other pathogens (excluding fungal infections
of nail beds) or any major episode of infection requiring hospitalization or treatment
with IV antibiotics (for IV antibiotics, this pertains to completion of last course of
antibiotic treatment) within 4 weeks of dosing

- Prior treatment with systemic immunotherapeutic agents, including, but not limited to,
radioimmuno-conjugates, antibody-drug conjugates, immune/cytokines, and monoclonal
antibodies (e.g., anti-CTLA4, anti-PD1, and anti-PDL1) within 4 weeks or five
half-lives of the drug, whichever is shorter, before G- or R-CHOP infusion on Cycle
1/Day 1

- History of treatment-emergent immune-related AEs associated with prior
immunotherapeutic agents, as follows: Grade >/=3 AEs, with the exception of Grade 3
endocrinopathy managed with replacement therapy; Grade 1-2 AEs that did not resolve to
baseline after treatment completion

- Contraindication to any of the individual components of the chemotherapy

- Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with
any other investigational anti-cancer agent within 4 weeks prior to study treatment at
Cycle 1/Day 1 infusion

- Prior solid organ transplantation

- Prior allogeneic stem cell transplantation

- Autologous stem cell transplantation within 100 days prior to Cycle 1/Day 1

- History of autoimmune disease

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibody therapy (or recombinant antibody-related fusion proteins)

- A history of confirmed progressive multifocal leukoencephalopathy

- Current or past history of central nervous system (CNS) lymphoma

- Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Participants who
received corticosteroid treatment with be documented to be on a stable dose of at least 4 weeks' duration prior to Cycle
1/Day 1. Participants may have received a brief (<7 days) course of systemic steroids
( control of lymphoma-related symptoms

- Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or
neurodegenerative disease

- Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol or interpretation of results, including diabetes
mellitus, history of relevant pulmonary disorders (bronchospasm, obstructive pulmonary
disease), and known autoimmune diseases

- Major surgery or significant traumatic injury < 28 days prior to the study treatment
infusion at Cycle 1/Day 1 (excluding biopsies) or anticipation of the need for major
surgery during study treatment

- Participants with another invasive malignancy that could affect compliance with the
protocol or interpretation of results

- Significant cardiovascular disease

- Left ventricular ejection fraction < 50%

- Administration of a live, attenuated vaccine within 4 weeks before study treatment
infusion on Cycle 1 Day 1 or anticipation that such a live, attenuated vaccine will be
required during the study

- History of illicit drug or alcohol abuse within 12 months prior to screening, in the
Investigator's judgment

- Any other diseases, metabolic dysfunction, physical examination finding (including
mental status), or clinical laboratory finding giving reasonable suspicion of a
disease or condition that would contraindicate the use of an investigational drug

- Participants with latent or active tuberculosis
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