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Sponsor: Sanofi
Conditions: Neoplasm
Interventions: Isatuximab SAR650984, Atezolizumab
Countries: United States, Belgium, Canada, Czechia, Italy, Netherlands, Spain, Taiwan
Primary Objectives: * Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC), or recurrent glioblastoma multiforme (GBM), and to determine the recommended Phase 2 dose (RP2D). * Phase 2: To assess response rate (RR) of isatuximab in combination with atezolizumab in participants with HCC or SCCHN or EOC. * Phase 2: To assess the progression free survival rate at 6 months (PFS-6) of isatuximab in combination with atezolizumab, or as a single agent in participants with GBM. Secondary Objectives: * To evaluate the safety profile of isatuximab monotherapy (GBM only), or in combination with atezolizumab in Phase 2. * To evaluate the immunogenicity of isatuximab and atezolizumab. * To characterize the pharmacokinetic (PK) profile of isatuximab single agent (GBM only) and atezolizumab in combination with isatuximab. * To assess the overall efficacy of isatuximab in combination with atezolizumab, or single agent (GBM only).
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria: * Participants must have a known diagnosis of either unresectable HCC, platinum-refractory recurrent/metastatic SCCHN, platinum-resistant/refractory EOC with evidence of measurable disease or recurrent GBM. * Greater than or equal to (\>=)18 years of age. * For participants with HCC: Documentation of progressive disease (PD) during or after treatment with either sorafenib or lenvatinib, or intolerance to the therapy. * For participants with SCCHN: Received and failed up to 2 lines of prior systemic anti-cancer therapy with documentation of tumor recurrence or PD within 6 months of last platinum-based therapy in primary, recurrent, or metastatic setting. * For participants with EOC: Received up to 3 lines of prior platinum-containing therapy when the disease was platinum-sensitive, and the participants should not have received any systemic therapy for platinum-resistant/refractory disease. Specific to France only: Documentation of PD on or after 1 line of anti-cancer therapy for platinum resistant/refractory disease (unless participants are ineligible or intolerant to standard of care for platinum-resistant/refractory disease). * For participants with GBM: Documentation of PD or first recurrence during or after temozolomide maintenance therapy for newly diagnosed GBM treated with 1st line radiotherapy plus concurrent temozolomide. Exclusion criteria: * Prior exposure to agent that blocks CD38 or participation in clinical studies with isatuximab. * For participants with HCC, SCCHN, EOC or GBM prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway. * Evidence of other immune related disease /conditions. * History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation. * Received a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. * Prior solid organ or bone marrow transplantation. * Eastern Cooperative Oncology Group performance status \>=2 for participants with HCC, SCCHN or EOC or Karnofsky performance score less than or equal to (\<=) 70 for participants with GBM. * Poor bone marrow reserve. * Poor organ function. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
- Santa Monica, California, United States
- Boston, Massachusetts, United States
- Houston, Texas, United States
- Brussels, Belgium
- Ghent, Belgium
- Toronto, Ontario, Canada
- Brno, Czechia
- Olomouc, Czechia
- Prague, Czechia
- Meldola, Forlì-Cesena, Italy
- Rozzano, Milano, Italy
- Milan, Italy
- Padova, Italy
- Rotterdam, Netherlands
- Barcelona, Barcelona [Barcelona], Spain
- Hospitalet de Llobregat, Castille and León, Spain
- Madrid, Madrid, Comunidad de, Spain
- Madrid / Madrid, Madrid, Comunidad de, Spain
- Pamplona, Navarre, Spain
- Madrid, Spain
- Kaohsiung City, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taipei, Taiwan
- Taipei, Taiwan
- Taipei, Taiwan