Back to resultsA Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
Primary Purpose
Malignant Melanoma, Squamous Cell Carcinoma of Skin
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
THOR-707
Cemiplimab
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Melanoma
Eligibility Criteria
Inclusion Criteria:
- Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
- Participants with:
- Cohort A: Histologically confirmed unresectable locally advanced or metastatic melanoma that are not amenable to local therapy
- Cohort B: Histologically confirmed metastatic CSCC or locally advanced
- CSCC that are not candidates for curative surgery or radiation. Special considerations for the following categories:
Participants with tumors arising on the cutaneous hair (non-glabrous) bearing lip with extension onto dry red lip (vermillion) may be eligible after communication with and approval from the Sponsor
Participants with the primary site is nose are only eligible if the primary site was skin, not nasal mucosa with outward extension to skin (the Investigator confirmed)
Participants with mixed histology in which the predominant histology is invasive CSCC may be eligible after communication with and approval from the Sponsor
- Participants in both cohorts must have at least one measurable lesion
- Provision of tumor tissue:
For participants in the dose escalation:
16 µg/kg: at screening, biopsy is optional but highly recommended; and on-treatment not required
24 µg/kg: at screening, biopsy is mandatory and on-treatment, optional but highly recommended
- For the other participants : Mandatory baseline biopsy for the participants to enroll in cohort A with skin metastasis and in cohort B. Mandatory on-treatment biopsy for participants in Cohort A with skin metastasis and participants in Cohort B.
- Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees: to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment.
- Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
- Capable of giving signed informed consent
Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Poor organ function
- Participants with baseline SpO2 ≤92%
- Active brain metastases or leptomeningeal disease.
- History of allogenic tissue/solid organ transplant.
- Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days.
- History of lung disease
- Comorbidity requiring corticosteroid therapy
- Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP
- Severe or unstable cardiac condition within 6 months prior to starting study treatment
- Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
- Known second malignancy either progressing or requiring active treatment within the last 3 years
For both cohorts:
- Prior immune checkpoint inhibitors except in the context of adjuvant or neoadjuvant; Participants who were on control arm of a study with an investigational anti-PD-1/PD-L1 are eligible.
- Received adjuvant or neoadjuvant therapy during the 6 months prior to development of metastatic disease.
- For Cohort A: any prior systemic treatment for advanced/metastatic disease
- For Cohort B: >2 prior lines of any systemic treatment for advanced/metastatic disease
- Inability to undergo any contrast-enhanced radiologic response assessment
- Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Beverly Hills Cancer Center & Optima Diagnostic Imaging-Site Number:8400007
- AdventHealth Orlando-Site Number:8400009
- University of Minnesota-Site Number:8400012
- Mount Sinai Health System-Site Number:8400006
- Investigational Site Number :0360001
- Investigational Site Number :0360002
- Investigational Site Number :1520003
- Investigational Site Number :1520005
- Investigational Site Number :1520002
- Investigational Site Number :1520001
- Investigational Site Number :1520004
- Investigational Site Number :2500003
- Investigational Site Number :2500002
- Investigational Site Number :2500005
- Investigational Site Number :2500001
- Investigational Site Number :2500006
- Investigational Site Number :2760004
- Investigational Site Number :2760001
- Investigational Site Number :2760003
- Investigational Site Number :2760006
- Investigational Site Number :2760005
- Investigational Site Number :2760002
- Investigational Site Number :3720001
- Investigational Site Number :3800003
- Investigational Site Number :3800005
- Investigational Site Number :3800001
- Investigational Site Number :3800004
- Investigational Site Number :3800002
- Investigational Site Number :6200003
- Investigational Site Number :6200001
- Investigational Site Number :6430003
- Investigational Site Number :6430004
- Investigational Site Number :6430001
- Investigational Site Number :7240001
- Investigational Site Number :7240004
- Investigational Site Number :7240003
- Investigational Site Number :7240002
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort A: Melanoma
Cohort B: cutaneous squamous cell carcinoma (CSCC)
Arm Description
SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Outcomes
Primary Outcome Measures
Objective response rate (ORR) in Cohort A (melanoma)
Cohort A (melanoma): Objective response rate (ORR) defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) 1.1.
Objective response rate (ORR) in Cohort B (CSCC)
Cohort B (CSCC): ORR defined as the proportion of participants who have a confirmed CR or PR determined by investigator per RECIST 1.1, or modified WHO criteria for medical photographs of external skin lesions, or composite criteria.
Secondary Outcome Measures
Phase 2 dose determination
Incidence of Dose-limiting toxicities (DLTs) during DLT observation period
Assessment of SAR444245 safety profile when combined with cemiplimab-Treatment Emergent Adverse Events
Incidence of treatment-emergent adverse event (TEAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
Assessment of SAR444245 safety profile when combined with cemiplimab-Serious Adverse Events
Incidence of serious-adverse events (SAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
Complete Response rate
Complete Response rate (CRR) defined as the proportion of participants who have a confirmed CR determined by the Investigator per RECIST 1.1 for melanoma participants and when applicable for CSCC participants (CR in localized unresectable CSCC is exploratory)
Time to Complete Response
Time to CR defined as the time from the first administration of IMP to the first tumor assessment at which the overall response was CR that is subsequently confirmed and determined by Investigator per RECIST 1.1 for melanoma participants and when applicable for CSCC participants
Time to Response
Time to Response (TTR), defined as the time from first administration of IMP to the first tumor assessment at which the overall response was CR or PR that is subsequently confirmed and determined by Investigator per RECIST 1.1 or modified WHO Criteria or composite criteria whichever relevant
Duration of Response (DoR)
Duration of Response (DoR), defined as the time from first tumor assessment at which the overall response was CR or PR that is subsequently confirmed until documented progressive disease (PD) determined by Investigator per RECIST 1.1 or modified WHO Criteria for medical photographs or composite criteria when relevant, or death from any cause, whichever occurs first
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) including confirmed CR or PR at any time or stable disease (SD) of at least 6 months (determined by Investigator per RECIST 1.1 or modified WHO criteria for medical photographs or composite criteria whichever relevant).
Progression Free Survival (PFS)
Progression Free Survival (PFS), defined as the time from the date of first IMP administration to the date of the first documented disease progression determined by Investigator per RECIST 1.1, or modified WHO Criteria for medical photographs when relevant or death due to any cause, whichever occurs first.
Concentration of SAR444245
Incidence of anti-drug antibodies (ADAs) against SAR444245
C trough of cemiplimab
Concentration observed just before treatment administration during repeated dosing (C trough)
C end_of_Infusion of cemiplimab
The concentration observed just after the end of infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04913220
Brief Title
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
Official Title
A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
August 22, 2023 (Actual)
Study Completion Date
January 27, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary Objective:
-To determine the antitumor activity of SAR444245 in combination with cemiplimab.
Secondary Objectives:
To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
To assess other indicators of antitumor activity
To assess the concentrations of SAR444245 when given in combination with cemiplimab
To assess the immunogenicity of SAR444245
To assess active concentrations of cemiplimab when given in combination with SAR444245
Detailed Description
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles or until PD], an end-of-treatment visit 30 days + 7 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or final cohort cut-off, whichever is earlier
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma, Squamous Cell Carcinoma of Skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A: Melanoma
Arm Type
Experimental
Arm Description
SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Arm Title
Cohort B: cutaneous squamous cell carcinoma (CSCC)
Arm Type
Experimental
Arm Description
SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Intervention Type
Drug
Intervention Name(s)
THOR-707
Intervention Description
Solution for infusion: intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
Libtayo® or generic
Intervention Description
Solution for infusion: intravenous infusion
Primary Outcome Measure Information:
Title
Objective response rate (ORR) in Cohort A (melanoma)
Description
Cohort A (melanoma): Objective response rate (ORR) defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) 1.1.
Time Frame
Baseline to the date of first documented progression or initiation of subsequent anticancer therapy or approximatively 9 months after the last participant receive first dose.
Title
Objective response rate (ORR) in Cohort B (CSCC)
Description
Cohort B (CSCC): ORR defined as the proportion of participants who have a confirmed CR or PR determined by investigator per RECIST 1.1, or modified WHO criteria for medical photographs of external skin lesions, or composite criteria.
Time Frame
Baseline to the date of first documented progression or initiation of subsequent anticancer therapy or approximatively 9 months after the last participant receive first dose.
Secondary Outcome Measure Information:
Title
Phase 2 dose determination
Description
Incidence of Dose-limiting toxicities (DLTs) during DLT observation period
Time Frame
The observation period is 1 cycle (21 days)
Title
Assessment of SAR444245 safety profile when combined with cemiplimab-Treatment Emergent Adverse Events
Description
Incidence of treatment-emergent adverse event (TEAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
Time Frame
From 1st IMP dose up to 30 days after the last dose of IMP
Title
Assessment of SAR444245 safety profile when combined with cemiplimab-Serious Adverse Events
Description
Incidence of serious-adverse events (SAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
Time Frame
From 1st IMP dose up to 90 days after the last dose of IMP
Title
Complete Response rate
Description
Complete Response rate (CRR) defined as the proportion of participants who have a confirmed CR determined by the Investigator per RECIST 1.1 for melanoma participants and when applicable for CSCC participants (CR in localized unresectable CSCC is exploratory)
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Time to Complete Response
Description
Time to CR defined as the time from the first administration of IMP to the first tumor assessment at which the overall response was CR that is subsequently confirmed and determined by Investigator per RECIST 1.1 for melanoma participants and when applicable for CSCC participants
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Time to Response
Description
Time to Response (TTR), defined as the time from first administration of IMP to the first tumor assessment at which the overall response was CR or PR that is subsequently confirmed and determined by Investigator per RECIST 1.1 or modified WHO Criteria or composite criteria whichever relevant
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Duration of Response (DoR)
Description
Duration of Response (DoR), defined as the time from first tumor assessment at which the overall response was CR or PR that is subsequently confirmed until documented progressive disease (PD) determined by Investigator per RECIST 1.1 or modified WHO Criteria for medical photographs or composite criteria when relevant, or death from any cause, whichever occurs first
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Clinical Benefit Rate (CBR)
Description
Clinical Benefit Rate (CBR) including confirmed CR or PR at any time or stable disease (SD) of at least 6 months (determined by Investigator per RECIST 1.1 or modified WHO criteria for medical photographs or composite criteria whichever relevant).
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Progression Free Survival (PFS)
Description
Progression Free Survival (PFS), defined as the time from the date of first IMP administration to the date of the first documented disease progression determined by Investigator per RECIST 1.1, or modified WHO Criteria for medical photographs when relevant or death due to any cause, whichever occurs first.
Time Frame
From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Concentration of SAR444245
Time Frame
At Day1, Day2, Day3 of Cycle1 and Day 1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21 days), maximum is up to approximately 24 months
Title
Incidence of anti-drug antibodies (ADAs) against SAR444245
Time Frame
At Day1 and Day 15 of Cycle1, at Day 1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21 days) and 30 days after last IMP administration, maximum is up to approximately 24 months.
Title
C trough of cemiplimab
Description
Concentration observed just before treatment administration during repeated dosing (C trough)
Time Frame
Day 1 of Cycle 1-2-4-7-10 + every 5th cycle (each cycle is 21 days) and 30 days after the last IMP administration, maximum is up to approximately 24 months.
Title
C end_of_Infusion of cemiplimab
Description
The concentration observed just after the end of infusion
Time Frame
Day 1 of Cycle 1-2-4-7-10 + every 5th cycle (each cycle is 21 days), maximum is up to approximately 24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
Participants with:
Cohort A: Histologically confirmed unresectable locally advanced or metastatic melanoma that are not amenable to local therapy
Cohort B: Histologically confirmed metastatic CSCC or locally advanced
CSCC that are not candidates for curative surgery or radiation. Special considerations for the following categories:
Participants with tumors arising on the cutaneous hair (non-glabrous) bearing lip with extension onto dry red lip (vermillion) may be eligible after communication with and approval from the Sponsor
Participants with the primary site is nose are only eligible if the primary site was skin, not nasal mucosa with outward extension to skin (the Investigator confirmed)
Participants with mixed histology in which the predominant histology is invasive CSCC may be eligible after communication with and approval from the Sponsor
Participants in both cohorts must have at least one measurable lesion
Provision of tumor tissue:
For participants in the dose escalation:
16 µg/kg: at screening, biopsy is optional but highly recommended; and on-treatment not required
24 µg/kg: at screening, biopsy is mandatory and on-treatment, optional but highly recommended
For the other participants : Mandatory baseline biopsy for the participants to enroll in cohort A with skin metastasis and in cohort B. Mandatory on-treatment biopsy for participants in Cohort A with skin metastasis and participants in Cohort B.
Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees: to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment.
Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
Capable of giving signed informed consent
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
Poor organ function
Participants with baseline SpO2 ≤92%
Active brain metastases or leptomeningeal disease.
History of allogenic tissue/solid organ transplant.
Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days.
History of lung disease
Comorbidity requiring corticosteroid therapy
Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP
Severe or unstable cardiac condition within 6 months prior to starting study treatment
Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
Known second malignancy either progressing or requiring active treatment within the last 3 years
For both cohorts:
Prior immune checkpoint inhibitors except in the context of adjuvant or neoadjuvant; Participants who were on control arm of a study with an investigational anti-PD-1/PD-L1 are eligible.
Received adjuvant or neoadjuvant therapy during the 6 months prior to development of metastatic disease.
For Cohort A: any prior systemic treatment for advanced/metastatic disease
For Cohort B: >2 prior lines of any systemic treatment for advanced/metastatic disease
Inability to undergo any contrast-enhanced radiologic response assessment
Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Facility Information:
Facility Name
Beverly Hills Cancer Center & Optima Diagnostic Imaging-Site Number:8400007
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
AdventHealth Orlando-Site Number:8400009
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
University of Minnesota-Site Number:8400012
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mount Sinai Health System-Site Number:8400006
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Investigational Site Number :0360001
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Investigational Site Number :0360002
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Investigational Site Number :1520003
City
Temuco
State/Province
La Araucanía
ZIP/Postal Code
4800827
Country
Chile
Facility Name
Investigational Site Number :1520005
City
Santaigo
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8241470
Country
Chile
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Investigational Site Number :1520004
City
Santiago
State/Province
Reg Metropolitana De Santiago
Country
Chile
Facility Name
Investigational Site Number :2500003
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Investigational Site Number :2500002
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Investigational Site Number :2500005
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number :2500001
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :2500006
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Investigational Site Number :2760004
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigational Site Number :2760001
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Investigational Site Number :2760003
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Investigational Site Number :2760006
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Investigational Site Number :2760005
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Investigational Site Number :2760002
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Investigational Site Number :3720001
City
Dublin 4
State/Province
Dublin
Country
Ireland
Facility Name
Investigational Site Number :3800003
City
Meldola (FC)
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Investigational Site Number :3800005
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Investigational Site Number :3800001
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number :3800004
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
Investigational Site Number :3800002
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Investigational Site Number :6200003
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Investigational Site Number :6200001
City
Porto
ZIP/Postal Code
4200-162
Country
Portugal
Facility Name
Investigational Site Number :6430003
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Investigational Site Number :6430004
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
Saint -Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Investigational Site Number :7240001
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Hospitalet de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08908
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
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