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 |
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.
- 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.
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.
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