EUCTR2015-004845-25-DE
Active, not recruiting
Phase 1
A phase Ib/II study evaluating the safety and efficacy of obinutuzumab in combination with atezolizumab plus polatuzumab vedotin in patients with relapsed or refractory follicular lymphoma and rituximab in combination with atezolizumab plus polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Follicular Lymphoma (FL) or Diffuse Large B-cell Lymphoma (DLBCL)
- Sponsor
- F. Hoffmann-La Roche Ltd.
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \>\=18 years
- •\- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •\- For G \+ Atezo \+ Pola treatment group: relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti\-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
- •\- For R \+ 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 patients 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 (DP) following autologous stem\-cell transplantation
- •\- Histologically documented CD20\-positive lymphoma as determined by the local laboratory
- •\- Fluorodeoxyglucose (FDG)\-avid lymphoma (i.e., PET\-positive lymphoma)
- •\- At least one bi\-dimensionally measurable lesion (\>1\.5 cm in its largest dimension by computed tomography (CT) scan or magnetic resonance imaging \[MRI])
- •\- Availability of a representative tumour specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL
- •\- For women of childbearing potential, agreement to remain abstinent or to use single highly effective or combined contraceptive methods that result in a failure rate of \<1% per year during the treatment period for \>\= 5 months after the last dose of atezolizumab, \>\= 12 months after last dose of rituximab, \>\= 12 months after the last dose of polatuzumab vedotin, and \>\=18 months after the last dose of obinutuzumab
- •\- For men, agreement to remain abstinent or to use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of obinutuzumab, rituximab and atezolizumab, and 5 months after the last dose of (polatuzumab vedotin) and to refrain from donating sperm during this same period
Exclusion Criteria
- •\- Grade 3b follicular lymphoma
- •\- History of transformation of indolent disease to DLBCL
- •\- Known CD20\-negative status at relapse or progression
- •\- Central nervous system (CNS) lymphoma or leptomeningeal infiltration
- •\- Prior allogeneic stem\-cell transplantation (SCT)
- •\- Completion of autologous SCT within 100 days prior to Day 1 of Cycle 1
- •\- Prior standard or investigational anti\-cancer therapy
- •\- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade \<\= 2 (as per National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE], v4\.0\) prior to Day 1 of Cycle 1
- •\- Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
- •\- History of solid organ transplantation and severe allergic or anaphylactic reaction to humanized, chimeric, or murine monoclonal antibodies
Outcomes
Primary Outcomes
Not specified
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