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Monoclonal Antibodies
SAR444245 + Cemiplimab for Advanced Skin Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 histologically confirmed metastatic CSCC or locally advanced CSCC that are not candidates for curative surgery or radiation (Cohort B)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Study Summary
This trial is testing a new drug, SAR444245, to see if it is effective in treating tumors when combined with cemiplimab. Secondary objectives include determining the recommended dose of SAR444245 and assessing the safety and other indicators of antitumor activity of the combination.
Who is the study for?
Adults with advanced skin cancers, specifically metastatic or locally advanced melanoma and squamous cell carcinoma not suitable for surgery/radiation. Participants must have measurable lesions, provide tumor tissue samples, and meet criteria regarding contraception and health status. Excluded are those with recent treatments/surgeries, unstable heart conditions, severe lung disease, poor organ function, active secondary cancers or brain metastases.Check my eligibility
What is being tested?
The trial is testing the effectiveness of SAR444245 combined with cemiplimab in treating advanced skin cancers. It aims to find the optimal dose for phase 2 trials while assessing safety profiles, antitumor activity indicators, drug concentrations in the body and immune response to SAR444245.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar cancer therapies include fatigue; reactions at injection site; flu-like symptoms such as fever and chills; nausea; changes in blood counts leading to increased infection risk; potential autoimmune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old or the legal adult age in my country.
Select...
I have advanced skin cancer that cannot be treated with surgery or radiation.
Select...
My melanoma cannot be removed by surgery and cannot be treated locally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) in Cohort A (melanoma)
Objective response rate (ORR) in Cohort B (CSCC)
Secondary outcome measures
Assessment of SAR444245 safety profile when combined with cemiplimab-Serious Adverse Events
Assessment of SAR444245 safety profile when combined with cemiplimab-Treatment Emergent Adverse Events
C end_of_Infusion of cemiplimab
+10 moreSide effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: cutaneous squamous cell carcinoma (CSCC)Experimental Treatment2 Interventions
SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Group II: Cohort A: MelanomaExperimental Treatment2 Interventions
SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,165 Previous Clinical Trials
3,515,256 Total Patients Enrolled
3 Trials studying Melanoma
473 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My daily activity is limited due to my health condition.My cancer started on the hairy part of my lip and may extend to the red part.I have a history of lung disease.I haven't taken antibiotics (except creams or ointments) in the last 14 days.I am a male willing to follow specific rules about sperm donation, contraception, and sex.My skin cancer started on the nose, not inside it.I am at least 18 years old or the legal adult age in my country.I have had more than 2 treatments for my advanced cancer.I cannot have imaging tests that require contrast dye.You must have at least one spot that can be measured to see if the treatment is working.I have not received a live-virus vaccine in the last 28 days.I am not pregnant, using birth control, and not donating eggs.I have advanced skin cancer that cannot be treated with surgery or radiation.I have received treatments for advanced cancer before.I haven't had serious heart problems in the last 6 months.I haven't had cancer treatment or major surgery in the last 28 days.My organs are not working well.I have another cancer that has been active or treated in the last 3 years.I have active cancer spread to my brain or its coverings.I need corticosteroids for another health issue.I have received an organ or tissue transplant from another person.Your oxygen level is below 92% when measured at the start of the study.My melanoma cannot be removed by surgery and cannot be treated locally.I have not used immune checkpoint inhibitors for my condition, except as part of initial treatment.I have an autoimmune disease treated in the last 2 years.I am able to understand and sign the consent form.I can provide tumor tissue samples when needed.I had treatment to prevent cancer return within 6 months before my cancer spread.If you have a type of skin cancer called invasive CSCC with some other types mixed in, you might still be able to join the study if the sponsor agrees.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B: cutaneous squamous cell carcinoma (CSCC)
- Group 2: Cohort A: Melanoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What maladies is Cemiplimab typically prescribed to treat?
"Cemiplimab is generally used to address ALK gene mutations, but also has been shown to aid in the management of metastatic cutaneous squamous cell carcinoma and other malignant neoplasms."
Answered by AI
Could you provide an overview of prior research related to Cemiplimab?
"Cemiplimab was first explored in 2010 by City of Hope. Since then, 6 trials have yielded results and there are currently 56 additional studies actively recruiting participants; many of these experiments take place within New york's boundaries."
Answered by AI
How many participants have been accepted for this experimentation?
"Unfortunately, the recruitment period for this medical trial has ended. It was initially posted on July 15th 2021 and its last update occurred October 31st 2022. Luckily, 816 trials are still actively seeking melanoma patients while 56 clinical studies require participants to be treated with Cemiplimab."
Answered by AI
In how many sites is this experiment being conducted?
"The current 8 trial sites are located in New york, Beverly Hills and Orlando as well as various other cities. To minimize travel needs, you should seek out the research centre closest to your residence when considering enrolling in this study."
Answered by AI
Are there vacancies available for participants in this experiment?
"The information on clinicaltrials.gov suggests that the recruitment period for this trial has ended, as it was first posted in July 2021 and last modified at the end of October 2022. Nonetheless, there are 872 other studies currently enrolling participants."
Answered by AI
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