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SAR444245 for Squamous Cell Carcinoma
Phase 2
Waitlist Available
Led By Renata Ferrarotto, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be amenable to TORS in the opinion of the treating head and neck surgeon
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 1 year.
Awards & highlights
Study Summary
This trial will test if SAR444245 in combination with cemiplimab can help kill cancer cells in patients with HPV-related oropharynx cancer who are scheduled to have surgery.
Eligible Conditions
- Squamous Cell Carcinoma
- Oropharyngeal Cancer
- Head and Neck Cancers
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
The head and neck surgeon believes that you are suitable for TORS (Transoral Robotic Surgery).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Side 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%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Autoimmune hepatitis
1%
Immune-mediated hepatitis
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
1Treatment groups
Experimental Treatment
Group I: SAR444245 plus CemiplimabExperimental Treatment2 Interventions
Participants will receive SAR444245 and Cemiplimab by vein on Day 1 of Cycles 1 and 2. Each drug's infusion should take about 30 minutes.
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?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,449 Total Patients Enrolled
SanofiIndustry Sponsor
2,158 Previous Clinical Trials
3,514,348 Total Patients Enrolled
Renata Ferrarotto, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
159 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA authorized SAR444245 for commercial use?
"SAR444245's safety has been partially tested and received a score of 2. Unfortunately, there is no evidence supporting its efficacy yet in clinical trials."
Answered by AI
Are individuals able to partake in this clinical experiment at the present moment?
"As indicated on clinicaltrials.gov, this particular medical trial is currently not enrolling participants. It was initially posted on February 28th 2023 and the most recent update occurred in September 7th 2022; however, there are other ongoing trials that require patient volunteers at the moment -- a total of 2,862 to be exact."
Answered by AI
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