Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03637764 : Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
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 and failed 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.

- 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03637764      |      Link to official Clinicaltrials.gov listing
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