Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies



Status:Recruiting
Conditions:Lung Cancer, Prostate Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:January 4, 2018
End Date:July 2021
Contact:Trial Transparency email recommended (Toll free number for US & Canada)
Email:Contact-Us@sanofi.com
Phone:800-633-1610

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A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab (SAR650984) in Combination With REGN2810, or Isatuximab Alone, in Patients With Advanced Malignancies

Primary Objectives:

- To characterize the safety and tolerability of isatuximab in combination with REGN2810
in patients with metastatic, castration-resistant prostate cancer (mCRPC) who are naïve
to anti-programmed cell death-1 (PD-1)/programmed cell death-ligand 1 (PD-L1)-containing
therapy, or non-small cell lung cancer (NSCLC) who progressed on
anti-PD-1/PD-L1-containing therapy, and to confirm the recommended Phase 2 dose (RP2D).

- To assess the response rate of isatuximab in combination with REGN2810 in patients with
either mCRPC who are anti-PD-1/PD-L1 therapy naive, or NSCLC who progressed on
anti-PD-1/PD-L1 therapy, or of isatuximab as single agent in patients with mCRPC.

Secondary Objectives:

- To evaluate the safety of the combination of isatuximab with REGN2810 or isatuximab
monotherapy.

- To evaluate the immunogenicity of isatuximab and REGN2810.

- To characterize the pharmacokinetic (PK) profile of isatuximab single agent or in
combination with REGN2810, and to characterize the PK of REGN2810 in combination with
isatuximab.

- To assess overall efficacy of isatuximab in combination with REGN2810 or as a single
agent.

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.

Inclusion criteria:

- Patients must have a known diagnosis of either metastatic castration-resistant
prostate cancer (mCRPC) or non-small cell lung cancer (NSCLC) with evidence of
measurable disease.

- Failure of, inability to, or refusal to receive standard of care.

- ≥18 years of age.

Exclusion criteria:

- Prior exposure to isatuximab or participation in clinical studies with isatuximab.

- For patients with mCRPC, 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 hematologic transplant.

- Eastern Cooperative Oncology Group performance status (PS) ≥2.

- 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.
We found this trial at
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