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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1205-1176 | Registry Identifier | ICTRP | |
| 2017-004766-94 | EudraCT Number |
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Sponsor terminated the study for non-safety reasons
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| Name | Class |
|---|---|
| BioNTech RNA Pharmaceuticals GmbH | INDUSTRY |
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Primary Objectives:
Secondary Objectives:
The expected duration of treatment for patients who benefit from study intervention may vary, based on progression date. Median expected duration of study per patient is estimated as 9 months in monotherapy and 12 months in combination therapy.
The maximum treatment duration for non-progressive patients is up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR441000 Dose Escalation Phase | Experimental | SAR441000 will be administered as intratumoral injection as monotherapy in patients with solid tumors over a 28-day cycle |
|
| SAR441000 + cemiplimab - Dose Escalation Phase | Experimental | SAR441000 will be administered as intratumoral injection in patients with solid tumors in combination with cemiplimab over a 21-day cycle |
|
| SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 failure | Experimental | 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 |
|
| SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 naive | Experimental | 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 |
|
| SAR441000 + cemiplimab Expansion CSCC, anti-PD-1 naive |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR441000 | Drug | Pharmaceutical form: concentrate for solution for injection Route of administration: intratumoral |
|
| Measure | Description | Time Frame |
|---|---|---|
| For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Monotherapy) | Incidence of DLTs at Cycle 1 (SAR441000 monotherapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression | Cycle 1; Cycle = 28 days for monotherapy |
| For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Combination therapy) | Incidence of DLTs during period from Cycle 1 Day 1 to Cycle 2 Day 8 (SAR441000 + cemiplimab combination therapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using NCI-CTCAE version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression | Cycle 1 Day 1 to Cycle 2 Day 8; Cycle = 21 days for combination therapy; overall assessment = 28 days |
| For dose escalation: Maximum tolerated dose (MTD) of SAR441000 (Monotherapy) | MTD of SAR441000 as monotherapy, determined during Cycle 1 of dose escalation phase | End of Dose Escalation phase (ie, End of Cycle 1 for last patient); Cycle = 28 days for monotherapy |
| For dose escalation: Maximum tolerated dose (MTD) of SAR441000 (Combination therapy) | MTD of SAR441000, in combination with cemiplimab, determined during period from Cycle 1 Day 1 to Cycle 2 Day 8 in dose escalation phase | End of Dose Escalation Phase (ie, End of Cycle 1 Day 1 to Cycle 2 Day 8 for last patient); Cycle = 21 days for combination; overall assesment = 28 days |
| Adverse Events | Incidence of Treatment Emergent Adverse Events (TEAE) during dose escalation phase |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Pharmacokinetic (PK) parameter for SAR441000 (Cmax) (Monotherapy) | Maximum plasma concentration (Cmax) of SAR4410000 as monotherapy observed over the dosing interval | Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 28 days for monotherapy |
| Assessment of Pharmacokinetic (PK) parameter for SAR441000 (Cmax) (Combination therapy) |
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Inclusion criteria:
Exclusion criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute- Site Number : 8400003 | Boston | Massachusetts | 02215 | United States | ||
| Cleveland Clinic - Cleveland- Site Number : 8400007 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40152791 | Result | Bechter O, Loquai C, Champiat S, Baurain JF, Grob JJ, Utikal J, Rottey S, Berrocal A, Hassel JC, Arance A, Sanmamed MF, Boers-Sonderen M, Gastman B, Gebhardt C, Delafontaine B, Sahin U, Tureci O, Brueck P, Abbadessa G, Marpadga R, Lee H, Yang Y, Buday B, Di Genova G, Wang H, Xia B, Lee JS, Lebbe C. A Phase I, First-in-Human, Dose-Escalation, Expansion Trial of Cytokine-Encoding Synthetic mRNA Mixture Alone or with Cemiplimab in Advanced Solid Tumors. Clin Cancer Res. 2025 Jun 13;31(12):2358-2369. doi: 10.1158/1078-0432.CCR-24-1983. |
| Label | URL |
|---|---|
| TED15297 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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 |
|
| SAR441000 + cemiplimab Expansion HNSCC, anti-PD-1 naive | Experimental | 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 |
|
| Cemiplimab REGN2810 | Drug | Pharmaceutical form: solution for injection Route of administration: intravenous |
|
| Up to end of treatment (Estimated median duration=12 months) |
| For Expansion: Objective Response Rate (ORR) | Assessment of overall response rate using standard imaging and RECIST 1.1 criteria | Estimated median duration = 12 months |
Maximum plasma concentration (Cmax) of SAR4410000 in combination with cemiplimab observed over the dosing interval |
| Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 21 days for combination therapy |
| Assessment of PK parameter for SAR441000 (AUC) (Monotherapy) | Area under the plasma concentration versus time curve (AUC) of SAR441000 as monotherapy over the dosing interval | Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 28 days for monotherapy |
| Assessment of PK parameter for SAR441000 (AUC) (Combination therapy) | Area under the plasma concentration versus time curve (AUC) of SAR441000 in combination with cemiplimab over the dosing interval | Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 21 days for combination therapy |
| Assessment of PK parameter (Ctrough) for SAR441000 | Trough Plasma Concentration (Ctrough) of SAR441000 as monotherapy and in combination with cemiplimab. It is defined as plasma concentration observed just before treatment administration during repeated dosing | Baseline to End of Treatment (Estimated median duration of 12 months) |
| Assessment of PK parameter for cemiplimab (Cmax) | Maximum plasma concentration of cemiplimab in combination with SAR441000, observed over the dosing interval | Cycle 1; Cycle duration is 21 days |
| Assessment of PK parameter of cemiplimab (AUC) | Area under the plasma concentration versus time curve of cemiplimab in combination with SAR441000 over the dosing interval | Cycle 1; Cycle duration is 21 days |
| Assessment of PK parameter for cemiplimab (Ctrough) | Trough plasma concentration of cemiplimab in combination with SAR441000, observed just before treatment administration during repeated dosing | Baseline to End of Treatment (Estimated median duration of 12 months) |
| Immunogenicity of SAR441000 and cemiplimab | Incidence of anti-drug antibody (ADA) positive patients for immunogenicity | Baseline to End of Study (Estimated median duration of 12 months) |
| DCR | Disease Control Rate (DCR) with SAR441000 in combination with cemiplimab. DCR is sum of Complete Response + Partial Response + Stable Disease | Baseline to End of Study (Estimated median duration of 12 months) |
| DoR | Duration of Response (DoR) with SAR441000 in combination with cemiplimab. DoR is time from initial response to the first documented tumor progression | Baseline to End of Study (Estimated median duration of 12 months) |
| Progression Free Survival (PFS) | Time from first drug administration to the first documented tumor progression or death from any cause, whichever comes first | Baseline to End of Study (Estimated median duration of 12 months) |
| Incidence of Treatment Emergent Adverse Events (TEAE) during dose expansion phase | Incidence of Adverse Events (AE)/ Serious AE (SAE) / Laboratory abnormalities considered to be adverse events | Baseline to End of Treatment (Estimated median duration of 12 months) |
| Recommended dose of SAR441000 for expansion phase (Combination therapy) | SAR441000 dose for administration in combination with cemiplimab selected for expansion phase based on MTD/MAD by the Bayesian model, the overall safety, activity and PK/PDy data | End of Dose Escalation Phase (ie, End of Cycle 1 Day 1 to Cycle 2 Day 8 for last patient); Cycle = 21 days for combination; overall assesment = 28 days |
| For Dose Expansion: Objective Response Rate (ORR) | Assessment of overall response rate using standard imaging by RECIST 1.1 and iRECIST criteria | Estimated median duration of 12 months |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| The University of Texas MD Anderson Cancer Center- Site Number : 8400002 | Houston | Texas | 77030 | United States |
| Investigational Site Number : 0560001 | Brussels | 1200 | Belgium |
| Investigational Site Number : 0560003 | Ghent | 9000 | Belgium |
| Investigational Site Number : 0560002 | Leuven | 3000 | Belgium |
| Investigational Site Number : 2500004 | Marseille | 13885 | France |
| Investigational Site Number : 2500002 | Paris | 75010 | France |
| Investigational Site Number : 2500001 | Villejuif | 94805 | France |
| Investigational Site Number : 2760005 | Hamburg | 20246 | Germany |
| Investigational Site Number : 2760004 | Heidelberg | 69120 | Germany |
| Investigational Site Number : 2760001 | Mainz | 55131 | Germany |
| Investigational Site Number : 2760003 | Mannheim | 68167 | Germany |
| Investigational Site Number : 2760006 | Tübingen | 72076 | Germany |
| Investigational Site Number : 5280002 | Nijmegen | 6525 GA | Netherlands |
| Investigational Site Number : 5280001 | Rotterdam | 3015 CE | Netherlands |
| Investigational Site Number : 7240004 | Barcelona | Catalunya [Cataluña] | 08036 | Spain |
| Investigational Site Number : 7240001 | Pamplona | Navarre | 31008 | Spain |
| Investigational Site Number : 7240002 | Valencia | 46014 | Spain |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
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