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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04913220




Registration number
NCT04913220
Ethics application status
Date submitted
28/05/2021
Date registered
4/06/2021

Titles & IDs
Public title
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
Scientific 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
Secondary ID [1] 0 0
U1111-1254-0189
Secondary ID [2] 0 0
ACT16845
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 0 0
Squamous Cell Carcinoma of Skin 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - THOR-707
Treatment: Drugs - Cemiplimab

Experimental: Cohort A: Melanoma - SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

Experimental: Cohort B: cutaneous squamous cell carcinoma (CSCC) - SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.


Treatment: Drugs: THOR-707
Solution for infusion: intravenous infusion

Treatment: Drugs: Cemiplimab
Solution for infusion: intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) in Cohort A (melanoma)
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
Objective response rate (ORR) in Cohort B (CSCC)
Timepoint [2] 0 0
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 [1] 0 0
Phase 2 dose determination
Timepoint [1] 0 0
The observation period is 1 cycle (21 days)
Secondary outcome [2] 0 0
Assessment of SAR444245 safety profile when combined with cemiplimab-Treatment Emergent Adverse Events
Timepoint [2] 0 0
From 1st IMP dose up to 30 days after the last dose of IMP
Secondary outcome [3] 0 0
Assessment of SAR444245 safety profile when combined with cemiplimab-Serious Adverse Events
Timepoint [3] 0 0
From 1st IMP dose up to 90 days after the last dose of IMP
Secondary outcome [4] 0 0
Complete Response rate
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Time to Complete Response
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Time to Response
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Duration of Response (DoR)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Clinical Benefit Rate (CBR)
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Progression Free Survival (PFS)
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Concentration of SAR444245
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Incidence of anti-drug antibodies (ADAs) against SAR444245
Timepoint [11] 0 0
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.
Secondary outcome [12] 0 0
C trough of cemiplimab
Timepoint [12] 0 0
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.
Secondary outcome [13] 0 0
C end_of_Infusion of cemiplimab
Timepoint [13] 0 0
Day 1 of Cycle 1-2-4-7-10 + every 5th cycle (each cycle is 21 days), maximum is up to approximately 24 months.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/02/2025
Actual
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Macquarie University
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Chile
State/province [2] 0 0
Reg Metropolitana De Santiago
Country [3] 0 0
Chile
State/province [3] 0 0
Antofagasta
Country [4] 0 0
Chile
State/province [4] 0 0
Temuco
Country [5] 0 0
France
State/province [5] 0 0
Bobigny
Country [6] 0 0
France
State/province [6] 0 0
Dijon
Country [7] 0 0
France
State/province [7] 0 0
Lille
Country [8] 0 0
France
State/province [8] 0 0
Nantes
Country [9] 0 0
France
State/province [9] 0 0
Pierre Benite
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Mannheim
Country [13] 0 0
Germany
State/province [13] 0 0
Minden
Country [14] 0 0
Germany
State/province [14] 0 0
München
Country [15] 0 0
Italy
State/province [15] 0 0
Napoli
Country [16] 0 0
Italy
State/province [16] 0 0
Perugia
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona [Barcelona]
Country [18] 0 0
Spain
State/province [18] 0 0
Cantabria

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04913220