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Checkpoint Inhibitor

SAR441000 + Cemiplimab for Cancer

Phase 1
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced solid tumors including lymphomas for which no standard alternative therapy is available (escalation phase)
Advanced melanoma (Stage IIIB-C or Stage IV, anti-PD-1/PD-L1 treated or not) or anti-PD-1/PD-L1 not treated advanced Head and Neck Squamous Cell Cancer or anti-PD-1/PD-L1 not treated Advanced Cutaneous Squamous Cell Cancer where no other alternative treatment option exists (expansion phases)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated median duration = 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, SAR441000, to see if it is safe and effective. The study will test different doses of the drug in different groups of patients to see what the maximum tolerated dose is. The study will also test how well the drug works in combination with another cancer drug, cemiplimab.

Who is the study for?
This trial is for adults with advanced solid tumors or lymphomas without standard treatment options. Participants must have at least three injectable lesions, measurable disease, and a life expectancy over 3 months. They should be willing to undergo tumor biopsies and use effective contraception.Check my eligibility
What is being tested?
The study tests SAR441000 alone or with Cemiplimab in patients with no alternative treatments. It aims to find the highest dose patients can tolerate, how the body processes the drugs, their safety profile, and how well they control cancer.See study design
What are the potential side effects?
Potential side effects include reactions at injection sites, immune system-related issues due to Cemiplimab (similar to other immunotherapies), fatigue, changes in blood cell counts affecting immunity and clotting, as well as possible liver and kidney function alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has no standard treatment options left.
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I have advanced melanoma or specific types of advanced cancer with limited treatment options.
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I have a tumor that can be biopsied again.
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I am 18 years old or older.
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I am willing to undergo a tumor biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated median duration = 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated median duration = 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
For Expansion: Objective Response Rate (ORR)
For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Combination therapy)
+3 more
Secondary outcome measures
Assessment of PK parameter (Ctrough) for SAR441000
Assessment of PK parameter for SAR441000 (AUC) (Combination therapy)
Assessment of PK parameter for SAR441000 (AUC) (Monotherapy)
+12 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: SAR441000 Dose Escalation PhaseExperimental Treatment1 Intervention
SAR441000 will be administered as intratumoral injection as monotherapy in patients with solid tumors over a 28-day cycle
Group II: SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 naiveExperimental Treatment2 Interventions
SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve melanoma over a 21-day cycle
Group III: SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 failureExperimental Treatment2 Interventions
SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced melanoma who have failed anti-PD-1/PD-L1 therapy. Treatment is administered over a 21-day cycle
Group IV: SAR441000 + cemiplimab Expansion HNSCC, anti-PD-1 naiveExperimental Treatment2 Interventions
SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve Head and Neck Squamous Cell Cancer (HNSCC) over a 21-day cycle
Group V: SAR441000 + cemiplimab Expansion CSCC, anti-PD-1 naiveExperimental Treatment2 Interventions
SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve Cutaneous Squamous Cell Carcinoma (CSCC) over a 21-day cycle
Group VI: SAR441000 + cemiplimab - Dose Escalation PhaseExperimental Treatment2 Interventions
SAR441000 will be administered as intratumoral injection in patients with solid tumors in combination with cemiplimab over a 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab REGN2810
2018
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,403 Total Patients Enrolled
BioNTech RNA Pharmaceuticals GmbHIndustry Sponsor
4 Previous Clinical Trials
307 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,222 Total Patients Enrolled

Media Library

Cemiplimab REGN2810 (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03871348 — Phase 1
Cancer Research Study Groups: SAR441000 + cemiplimab Expansion HNSCC, anti-PD-1 naive, SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 naive, SAR441000 Dose Escalation Phase, SAR441000 + cemiplimab Expansion CSCC, anti-PD-1 naive, SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 failure, SAR441000 + cemiplimab - Dose Escalation Phase
Cancer Clinical Trial 2023: Cemiplimab REGN2810 Highlights & Side Effects. Trial Name: NCT03871348 — Phase 1
Cemiplimab REGN2810 (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03871348 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are taking part in this research?

"The recruitment phase for this trial has concluded; it was posted on the 3rd of January, 2019 and last edited on 8th November, 2022. If you are seeking other trials to participate in, presently 635 clinical studies involving neoplasms and metastatic diseases welcome participants as well as 56 SAR441000-related experiments."

Answered by AI

What are the ultimate objectives of this clinical experiment?

"The primary goal of this trial is to determine the Maximum Tolerated Dose (MTD) of SAR441000 when administered monotherapeutically. Secondary objectives involve evaluating PK parameter Ctrough, ascertaining a recommended dose for expansion phase combination therapy, monitoring overall safety and efficacy data, measuring Cmax in conjunction with cemiplimab over the dosing interval. The measurements will be made during End of Cycle 1 Day 1 until Cycle 2 Day 8 for last patient; where cycle = 21 days & assessment period = 28 days."

Answered by AI

What medical indications require SAR441000?

"SAR441000 is capable of treating alk gene mutations, as well as various other conditions including advanced directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."

Answered by AI

Is enrollment available for the experimental protocol at present?

"As per information from clinicaltrials.gov, this trial is no longer recruiting participants. It was initially posted on March 1st 2019 and last edited on August 11th 2022. Despite the current lack of recruitment for this particular study, 691 other medical trials are actively looking for volunteers right now."

Answered by AI

How many healthcare facilities have implemented this trial protocol?

"The research is taking place at 5 locations, including Houston, Fairway and Cleveland. To reduce travel demands for participants, it's recommend that you opt for the closest trial site to your residence."

Answered by AI

Has SAR441000 been given the necessary authorization by the FDA?

"SAR441000's safety record is not yet well-established, thus it received a rating of 1. This is reflective of the fact that this drug is still in its early clinical trials state and there are limited data regarding both efficacy and security."

Answered by AI

Are there any other precedents of SAR441000 being tested for its therapeutic abilities?

"SAR441000 was initially explored in 2010 at City of Hope, and since then there have been 6 successful studies. Currently, 56 trials are being conducted nationwide; Houston is a particularly active hub for this research."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
2019. "A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03871348.
~12 spots leftby Apr 2025
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