Phase 2
Completed N=36
A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Source: ClinicalTrials.gov NCT02729896 ↗Enrolled (actual)
36
Serious AEs
17.7%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants With CR at EOI, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan — 33.33; 14.30; 12.50 Percentage of participants
Summary
This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of obinutuzumab + Atezo + Pola in participants with relapsed or refractory (RR) FL and rituximab + Atezo + Pola in participants with RR DLBCL. The study will include an initial dose-escalation phase designed to determine the recommended Phase 2 dose (RP2D) for Pola in this treatment combination, followed by an expansion phase in which Pola will be given at the RP2D. All participants will receive induction treatment with obinutuzumab + Atezo + Pola for 6 cycles. RR FL participants achieving a complete response (CR), partial response (PR), or stable disease (SD) at the end of induction (EOI) will receive maintenance treatment with obinutuzumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With CR at EOI, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan |
33.33; 14.30; 12.50 | — |
| SECONDARY Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone |
0.00; 57.14; 12.50 | — |
| SECONDARY Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans |
33.33; 57.14; 25.00 | — |
| SECONDARY Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of CT Scans Alone |
33.33; 57.14; 25.00 | — |
| SECONDARY Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone |
33.3; 14.3; 12.5; 0; 42.9; 12.5 | — |
| SECONDARY Percentage of Participants With Adverse Events and Serious Adverse Events |
100.00; 100.00; 81.00 | — |
| SECONDARY Serum Obinutuzumab Concentration |
NA; NA; 308; 295; 351; 403 | — |
| SECONDARY Serum Rituximab Concentration |
30.4; 197; 43.5; 84.8; 101; 239 | — |
| SECONDARY Serum Atezo Concentration |
NA; NA; NA; 332; 365; 355 | — |
| SECONDARY Serum Pola Concentration |
0.136; 2.91; 0.847; 35.9; 2.54; 2.62 | — |
| SECONDARY Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab |
0; 0 | — |
| SECONDARY Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab |
5.6; 94.4; 5.6; 94.4; 100; 100 | — |
| SECONDARY Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo |
0; 0; 5.3; 0; 0; 94.7 | — |
| SECONDARY Percentage of Participants With ATAs to Pola |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- For obinutuzumab + Atezo + Pola treatment group: relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-Cluster of Differentiation (CD)20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
- For rituximab + Atezo + Pola treatment group: relapsed or refractory DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody, in participants who are not eligible for second line combination (immuno-) chemotherapy and autologous stem-cell transplantation or who have failed second line combination (immuno-) chemotherapy or experienced disease progression following autologous stem-cell transplantation
- Histologically documented CD20-positive lymphoma and fluorodeoxyglucose (FDG)-avid lymphoma (that is PET-positive lymphoma) with at least one bi-dimensionally measurable lesion
- Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL
- For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or to use contraceptive methods that result in a failure rate of less than ( =) 5 months after last dose of Atezo, >= 12 months after last dose of rituximab, >= 12 months after last dose of Pola, and >= 18 months after last dose of obinutuzumab
- For men: agreement to remain abstinent or to use contraceptive measures that result in a failure rate of ) 1 neuropathy
- Major surgical procedure other than for diagnosis within 28 days prior to D1C1
- Inadequate hematologic function, renal function, and liver function
- Pregnant or lactating women
- Life expectancy < 3 months
Data sourced from ClinicalTrials.gov (NCT02729896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.