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SAR444245 + Anticancer Therapies for Head and Neck Cancer
Study Summary
This trial is investigating whether the drug SAR444245, when combined with other cancer treatments, will result in a significant increase in the number of people with head and neck squamous cell carcinoma (HNSCC) who respond to the treatment. The trial is divided into three parts, each testing the drug in combination with a different treatment. Part 1 is testing SAR444245 combined with the anti-PD1 antibody pembrolizumab in people who are treatment-naive for recurrent and/or metastatic HNSCC. Part 2 is testing SAR444245 combined with the anti-PD1 antibody pembrolizumab in
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I need more than 10 mg of prednisone daily for a health issue, but not for an autoimmune disorder.My cancer can be measured by tests.My throat cancer has been tested for HPV.My daily activity is limited due to my health condition.My cancer is in the mouth, throat, or voice box and cannot be cured with more treatment.I have previously been treated with a PD-1/PD-L1 inhibitor, or was in a study but confirmed not to have received it.I cannot stop my blood pressure medicine for 36 hours before taking a new drug.I am 18 years old or older.I have used cetuximab for local cancer without worsening for 4 months after treatment.I have been treated with IL2 for cancer before.
- Group 1: Cohort A1 (sub study 01) treatment- naïve
- Group 2: Cohort B1: (sub study 04) PD1/PD-L1 and platinum-based treatments
- Group 3: Cohort B2: (sub study 05) cetuximab- naïve
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is recruitment still open for this clinical trial?
"Unfortunately, this particular trial is no longer looking for patients. Although, if you're interested in other studies, there are 2761 trials for oral squamous cell carcinoma and 1123 for Pembrolizumab (Keytruda®) that are currently enrolling participants."
What are some of the key benefits that Pembrolizumab (Keytruda®) offers patients?
"Pembrolizumab (Keytruda®) is most frequently used to treat patients with unresectable melanoma. It can also be prescribed to manage microsatellite instability high, high risk of recurrence, and intolerance to irinotecan."
What are the precedents for this kind of clinical research?
"There are 1123 ongoing studies for Pembrolizumab (Keytruda®) in 65 countries and 3234 cities. The first study, conducted by Bristol-Myers Squibb in 2005, completed Phase 2 drug approval with 154 participants. In the 15 years since then, 612 more trials have been carried out."
How many people are allowed to participate in this clinical trial at any one time?
"This particular clinical trial is not recruiting patients right now. The study was first posted on October 8th, 2021 and was updated last on October 31st, 2022. However, there are 2761 other studies actively recruiting patients with oral squamous cell carcinoma and 1123 studies for Pembrolizumab (Keytruda®) that are currently looking for participants."
Could you please provide more information about other Pembrolizumab (Keytruda®) clinical trials?
"Pembrolizumab (Keytruda®) is being investigated in 1123 active studies, 149 of which are Phase 3 trials. Most of the Pembrolizumab (Keytruda®) trials are taking place in Scottsdale, Arizona; however, there are 41304 total clinical trial locations for Pembrolizumab (Keytruda®)."
Has the FDA cleared Pembrolizumab (Keytruda®) for public use?
"Given that there is some evidence of safety, but none for efficacy, our team has given Pembrolizumab (Keytruda®) a score of 2."
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