A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

  • STATUS
    Recruiting
  • End date
    Nov 14, 2023
  • participants needed
    80
  • sponsor
    Sanofi
Updated on 15 April 2022
metastatic melanoma
measurable disease
metastasis

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

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

Details
Condition Malignant Melanoma, Squamous Cell Carcinoma of Skin
Treatment Cemiplimab, THOR-707, SAR444245
Clinical Study IdentifierNCT04913220
SponsorSanofi
Last Modified on15 April 2022

Eligibility

Yes No Not Sure

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
CSCC that are not candidates for curative surgery or radiation. Special considerations for the following categories
Cohort B: Histologically confirmed metastatic CSCC or locally advanced
Participants in both cohorts must have at least one measurable lesion
Participants with the primary site is nose are only eligible if the primary site was skin
Participants with tumors arising on the cutaneous hair (non-glabrous) bearing lip with
not nasal mucosa with outward extension to skin (the Investigator confirmed)
extension onto dry red lip (vermillion) may be eligible after communication with and
approval from the Sponsor
Participants with mixed histology in which the predominant histology is invasive CSCC may
be eligible after communication with and approval from the Sponsor
Capable of giving signed informed consent
µg/kg: at screening, biopsy is optional but highly recommended; and on-treatment not
required
Provision of tumor tissue
For participants in the dose escalation
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
woman of childbearing potential (WOCBP) or are a WOCBP that agrees: to use approved
participants in Cohort A with skin metastasis and participants in Cohort B
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
Females are eligible to participate if they are not pregnant or breastfeeding, not a
or cryopreserving eggs for 180 days after discontinuing study treatment
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

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 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
For both cohorts
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
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
History of allogenic tissue/solid organ transplant
Last administration of prior antitumor therapy or any investigational treatment within
days or less than 5 times the half-life, whichever is shorter; major surgery or
local intervention within 28 days
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
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
Receipt of a live-virus vaccination within 28 days of planned treatment start
Seasonal flu vaccines that do not contain live virus are permitted
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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