Status:
TERMINATED
Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies
Lead Sponsor:
Sanofi
Conditions:
Prostate Cancer
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Primary Objectives: * To characterize the safety and tolerability of isatuximab in combination with REGN2810 in participants with metastatic, castration-resistant prostate cancer (mCRPC) who were naï...
Detailed Description
The total study duration per participant was 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.
Eligibility Criteria
Inclusion
- Participants must had 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.
- Greater than or equal to (\>=) 18 years of age.
Exclusion
- Prior exposure to isatuximab or participation in clinical studies with isatuximab.
- For participants 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.
- Had received a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus were 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03367819
Start Date
January 4 2018
End Date
March 10 2021
Last Update
May 16 2022
Active Locations (16)
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1
Investigational Site Number 8400003
Birmingham, Alabama, United States, 35249
2
Investigational Site Number 8400007
Atlanta, Georgia, United States, 30322
3
Investigational Site Number 8400002
Hackensack, New Jersey, United States, 07601
4
Investigational Site Number 8400005
Nashville, Tennessee, United States, 37203