Ovarian Cancer Clinical Trial

Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

Summary

Primary Objectives:

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.

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).

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Full Description

The total study duration per patient is up to 28 months including an up to 28 days screening period, an up to 24 months treatment period, and a 3 months safety follow up period.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria :

Patients must have a known diagnosis of either unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC) with evidence of measurable disease or recurrent glioblastoma multiforme (GBM).
≥18 years of age.
For patients with HCC: Documentation of progressive disease (PD) during or after treatment with either sorafenib or lenvatinib, or intolerance to the therapy.
For patients 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 patients with EOC: Received up to 3 lines of prior platinum-containing therapy when the disease was platinum-sensitive, and the patients 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 patients are ineligible or intolerant to standard of care for platinum-resistant/refractory disease).
For patients 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 patients 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.
Has 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 (PS) ≥2 for patients with HCC, SCCHN or EOC or Karnofsky performance score ≤ 70 for patients with GBM.
Poor bone marrow reserve.
Poor organ function.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

107

Study ID:

NCT03637764

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 26 Locations for this study

See Locations Near You

Investigational Site Number :8400004
Santa Monica California, 90404, United States
Investigational Site Number :8400207
Boston Massachusetts, 02114, United States
Investigational Site Number :8400007
Boston Massachusetts, 02115, United States
Investigational Site Number :8400002
Houston Texas, 77030, United States
Investigational Site Number :0560001
Bruxelles , 1200, Belgium
Investigational Site Number :0560002
Gent , 9000, Belgium
Investigational Site Number :1240001
Toronto Ontario, M5G 2, Canada
Investigational Site Number :2030001
Brno , 65653, Czechia
Investigational Site Number :2030003
Olomouc , 77900, Czechia
Investigational Site Number :2030002
Praha 2 , 12808, Czechia
Investigational Site Number :3800007
Meldola Forlì-Cesena, 47014, Italy
Investigational Site Number :3800003
Rozzano Milano, 20089, Italy
Investigational Site Number :3800009
Milano , 20141, Italy
Investigational Site Number :3800004
Padova , 35128, Italy
Investigational Site Number :5280001
Rotterdam , 3015 , Netherlands
Investigational Site Number :7240001
Barcelona Barcelona [Barcelona], 08035, Spain
Investigational Site Number :7240006
Hospitalet de Llobregat Castilla Y León, 08908, Spain
Investigational Site Number :7240003
Madrid / Madrid Madrid, Comunidad De, 28040, Spain
Investigational Site Number :7240004
Madrid Madrid, Comunidad De, 28050, Spain
Investigational Site Number :7240008
Pamplona Navarra, 31008, Spain
Investigational Site Number :7240007
Madrid , 28041, Spain
Investigational Site Number :1580005
Kaohsiung , 807, Taiwan
Investigational Site Number :1580002
Tainan , 704, Taiwan
Investigational Site Number :1580001
Taipei 100 , , Taiwan
Investigational Site Number :1580003
Taipei , 104, Taiwan
Investigational Site Number :1580006
Taipei , 112, Taiwan
Investigational Site Number :1580004
Taipei , 114, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

107

Study ID:

NCT03637764

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

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