Ovarian Cancer Clinical Trial
Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies
Phase1: 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).
Phase2: To assess response rate (RR) of isatuximab in combination with atezolizumab in participants with HCC or SCCHN or EOC.
Phase2: 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.
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).
The total study duration per participant was up to 28 months including up to 28 days screening period, up to 24 months treatment period, and a 3 month safety follow up period.
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.
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.
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There are 25 Locations for this study
Santa Monica California, 90404, United States
Boston Massachusetts, 02115, United States
Houston Texas, 77030, United States
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Toronto Ontario, M5G 2, Canada
Brno , 65653, Czechia
Olomouc , 77900, Czechia
Praha 2 , 12808, Czechia
Meldola ForlÃ¬-Cesena, 47014, Italy
Rozzano Milano, 20089, Italy
Milano , 20141, Italy
Padova , 35128, Italy
Rotterdam , 3015 , Netherlands
Barcelona Barcelona [Barcelona], 08035, Spain
Hospitalet de Llobregat Castilla Y LeÃ³n, 08908, Spain
Madrid / Madrid Madrid, Comunidad De, 28040, Spain
Madrid Madrid, Comunidad De, 28050, Spain
Pamplona Navarra, 31008, Spain
Madrid , 28041, Spain
Kaohsiung , 807, Taiwan
Tainan , 704, Taiwan
Taipei 100 , , Taiwan
Taipei , 104, Taiwan
Taipei , 112, Taiwan
Taipei , 114, Taiwan
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