A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Adva… (NCT04913220) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
Stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns
United States, Australia, Chile46 participantsStarted 2021-07-15
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All Cohorts: Objective Response Rate (ORR)
Timeframe: From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B)