What side effects are associated with this type of intervention?

Common treatments for Oral Squamous Cell Carcinoma (OSCC) involving immunotherapy, such as the combination of SAR444245 with pembrolizumab or cetuximab, can lead to several side effects. Pembrolizumab, an anti-PD1 antibody, is associated with immune-related adverse events including fatigue, rash, diarrhea, and endocrinopathies like hypothyroidism. Cetuximab, an EGFR inhibitor, commonly causes skin reactions, infusion-related reactions, and hypomagnesemia. Both treatments can also lead to more severe but less common side effects such as pneumonitis and colitis. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Pembrolizumab, an anti-PD1 antibody, has been approved by the FDA for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), including oral squamous cell carcinoma (OSCC), particularly in patients who have progressed on or after platinum-based chemotherapy. Cetuximab, an EGFR inhibitor, is also FDA-approved for HNSCC and is used in combination with platinum-based chemotherapy and 5-fluorouracil for the first-line treatment of recurrent locoregional disease or metastatic disease. These approvals highlight the use of immunotherapy and targeted therapy in treating OSCC, similar to the investigational combinations being studied with SAR444245.

What other types of research exist?

Promising novel alternatives for OSCC patients include: 1) Budigalimab, an anti-PD-1 monoclonal antibody, which has shown efficacy in HNSCC patients. 2) Nivolumab, another anti-PD-1 therapy, which has demonstrated improved overall survival in R/M HNSCC patients. 3) Atezolizumab, an anti-PD-L1 antibody, which has shown clinical activity and safety in advanced HNC. These therapies represent viable options for patients considering treatment in 2024.

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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

Must not have

Eastern Cooperative Oncology Group (ECOG) performance status of ≥2

Has received prior IL2-based anticancer treatment

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

No Placebo-Only Group

Summary

This trial tests a new drug, SAR444245, combined with other cancer treatments in adults with head and neck cancer. It aims to see if this combination can better help the immune system fight the cancer. The study includes patients who are either untreated or have received prior treatments.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My daily activity is limited due to my health condition.

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I have been treated with IL2 for cancer before.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Clinical benefit rate (CBR)

Duration of response (DoR)

Progression free survival (PFS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2017

Completed Phase 3

~3150

Cetuximab

2011

Completed Phase 3

~2480

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Oral Squamous Cell Carcinoma (OSCC) include immunotherapy and targeted therapy. Pembrolizumab, an anti-PD1 antibody, blocks the PD-1/PD-L1 pathway, enabling the immune system to recognize and attack cancer cells. Cetuximab, an EGFR inhibitor, targets the epidermal growth factor receptor to inhibit tumor growth. Combining these with SAR444245, an immunomodulatory agent, aims to enhance the immune response and improve treatment efficacy. This multi-faceted approach is crucial for OSCC patients as it may lead to better clinical outcomes by effectively targeting the cancer through different mechanisms.

Novel immune-modulating drugs for advanced head and neck cancer.Immunotherapeutic Approaches to Head and Neck Cancer.Immunotherapy for head and neck cancer: the future of treatment?