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EGFR Inhibitor

SAR444245 + Anticancer Therapies for Head and Neck Cancer

Phase 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
Measurable disease
Known HPV p16 status for oropharyngeal cancer
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 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

Who is the study for?
Adults with head and neck squamous cell carcinoma (HNSCC) not suitable for curative therapy can join. They must have measurable disease, known HPV status if cancer is oropharyngeal, and agree to contraception guidelines. Excluded are those with certain health conditions like low oxygen levels without support, poor performance status, specific prior treatments depending on the cohort they're entering, or needing systemic steroids.Check my eligibility
What is being tested?
The trial tests SAR444245 combined with other cancer drugs in different cohorts: Cohort A1 pairs it with pembrolizumab for treatment-naïve R/M HNSCC; Cohort B1 uses the same combo but after PD1/PD-L1 & platinum-based treatments; Cohort B2 combines it with cetuximab post-platinum regimen in cetuximab-naive patients after up to two failed R/M therapies.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to pembrolizumab or SAR444245 such as inflammation of organs, infusion reactions from any drug used, fatigue, skin rash from cetuximab and possible allergic reactions. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by tests.
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My throat cancer has been tested for HPV.
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My cancer is in the mouth, throat, or voice box and cannot be cured with more treatment.
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I am 18 years old or older.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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)
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DoR)
Progression free survival (PFS)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort B2: (sub study 05) cetuximab- naïveExperimental Treatment2 Interventions
Participants with R/M HNSCC, who are cetuximab-naïve, have received treatment with a platinum-based regimen, and have failed no more than 2 regimens for R/M disease, will receive treatment with cetuximab followed by SAR444245. Cetuximab IV will be given on days 1, 8, and 15 of each 21 day. SAR444245 will be administered by IV infusion on Day 1 of each 21-day treatment cycle. Dosing of both drugs is to continue until disease progression, unacceptable toxicity, or withdrawal of consent.
Group II: Cohort B1: (sub study 04) PD1/PD-L1 and platinum-based treatmentsExperimental Treatment2 Interventions
Participants with HNSCC who have received treatment with a PD1/PD-L1-based regimen & platinum-based regimen and have failed no more than 2 regimens for R/M disease, will receive pembrolizumab followed by SAR444244. Both drugs administered IV infusion on Day 1 of each 21-day treatment cycle for up to 35 cycles
Group III: Cohort A1 (sub study 01) treatment- naïveExperimental Treatment2 Interventions
Participants with HNSCC, who are treatment-naïve for R/M disease and have a PD-L1 Combined Positive Score (CPS) ≥1, will receive pembrolizumab followed by SAR444245. Both drugs administered by intravenous (IV) infusion on Day 1 of each 21-day treatment cycle for up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab (Keytruda®)
2019
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,158 Previous Clinical Trials
3,514,289 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,896 Total Patients Enrolled

Media Library

Cetuximab (EGFR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05061420 — Phase 2
Oral Squamous Cell Carcinoma Research Study Groups: Cohort A1 (sub study 01) treatment- naïve, Cohort B1: (sub study 04) PD1/PD-L1 and platinum-based treatments, Cohort B2: (sub study 05) cetuximab- naïve
Oral Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05061420 — Phase 2
Cetuximab (EGFR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061420 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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®)."

Answered by AI

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."

Answered by AI
~17 spots leftby Mar 2025