Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies
Stopped early · Phase 1/Phase 2
Conditions studied: Neoplasm
In brief
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).
Key facts
- Study ID
- NCT03637764
- Run by
- Sanofi
- People needed
- 107
- Starts
- 2018-08-06
- Expected to finish
- 2022-05-11
- Last updated by the study team
- 2023-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Investigational Site Number :8400004 — Santa Monica, California, United States
- Investigational Site Number :8400007 — Boston, Massachusetts, United States
- Investigational Site Number :8400002 — Houston, Texas, United States
- Investigational Site Number :0560001 — Brussels, Belgium
- Investigational Site Number :0560002 — Ghent, Belgium
- Investigational Site Number :1240001 — Toronto, Ontario, Canada
- Investigational Site Number :2030001 — Brno, Czechia
- Investigational Site Number :2030003 — Olomouc, Czechia
- Investigational Site Number :2030002 — Prague, Czechia
- Investigational Site Number :3800007 — Meldola, Forlì-Cesena, Italy
- Investigational Site Number :3800003 — Rozzano, Milano, Italy
- Investigational Site Number :3800009 — Milan, Italy
- Investigational Site Number :3800004 — Padova, Italy
- Investigational Site Number :5280001 — Rotterdam, Netherlands
- Investigational Site Number :7240001 — Barcelona, Barcelona [Barcelona], Spain
- Investigational Site Number :7240006 — Hospitalet de Llobregat, Castille and León, Spain
- Investigational Site Number :7240004 — Madrid, Madrid, Comunidad de, Spain
- Investigational Site Number :7240003 — Madrid / Madrid, Madrid, Comunidad de, Spain
- Investigational Site Number :7240008 — Pamplona, Navarre, Spain
- Investigational Site Number :7240007 — Madrid, Spain
- Investigational Site Number :1580005 — Kaohsiung City, Taiwan
- Investigational Site Number :1580002 — Tainan, Taiwan
- Investigational Site Number :1580003 — Taipei, Taiwan
- Investigational Site Number :1580006 — Taipei, Taiwan
- Investigational Site Number :1580004 — Taipei, Taiwan
Full record on ClinicalTrials.gov
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