What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly those involving anti-PD-1 monoclonal antibodies like cemiplimab, can cause immune-related adverse events. These include inflammation in various organ systems, such as colitis, pneumonitis, hepatitis, endocrinopathies, and skin reactions. Combination therapies, such as nivolumab with ipilimumab, can increase the frequency and severity of these side effects. Common side effects include fatigue, rash, diarrhea, and pruritus, while severe side effects can include pneumonitis, colitis, and hepatitis, which may require immunosuppressive treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for melanoma that involve antitumor activity and anti-PD-1 monoclonal antibodies. Notably, nivolumab and pembrolizumab are anti-PD-1 therapies that have shown significant efficacy in treating advanced melanoma. Additionally, the combination of nivolumab and ipilimumab, an anti-CTLA-4 antibody, has been approved for untreated melanoma, demonstrating improved response rates and progression-free survival compared to monotherapy. These treatments are similar to the combination of SAR444245 and cemiplimab being studied for their antitumor activity in advanced skin cancers.

What other types of research exist?

Promising alternatives to SAR444245 in combination with cemiplimab for melanoma patients include: 1) LY3022855 (CSF-1R inhibitor) in combination with durvalumab or tremelimumab, which has shown safety and antitumor activity in advanced solid tumors. 2) Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate, which has demonstrated efficacy in diverse epithelial cancers. 3) Nivolumab plus ipilimumab, which is a well-established combination for durable long-term responses in advanced melanoma.

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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)

Must not have

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

For Cohort B: >2 prior lines of any systemic treatment for advanced/metastatic disease

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 is testing a new drug (SAR444245) together with an existing cancer treatment (cemiplimab) to see if they can better fight tumors. It targets patients whose tumors may not respond well to current treatments. The goal is to find out if this combination can improve patient outcomes by making the existing treatment more effective.

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.

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.

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 below

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I am at least 18 years old or the legal adult age in my country.

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I have advanced skin cancer that cannot be treated with surgery or radiation.

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My melanoma cannot be removed by surgery and cannot be treated locally.

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 had more than 2 treatments for my advanced cancer.

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I cannot have imaging tests that require contrast dye.

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I have not received a live-virus vaccine in the last 28 days.

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I have received treatments for advanced cancer before.

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I haven't had cancer treatment or major surgery in the last 28 days.

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My organs are not working well.

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I have another cancer that has been active or treated in the last 3 years.

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I have active cancer spread to my brain or its coverings.

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I need corticosteroids for another health issue.

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I have received an organ or tissue transplant from another person.

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I have an autoimmune disease treated in the last 2 years.

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I had treatment to prevent cancer return within 6 months before my cancer spread.

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) in Cohort A (melanoma)

Objective response rate (ORR) in Cohort B (CSCC)

Secondary study objectives

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

+8 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Constipation

13%

Diarrhoea

13%

Infusion related reaction

13%

Vomiting

13%

Nausea

13%

Subcutaneous abscess

13%

Hyperthyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Awards & Highlights

No Placebo-Only Group

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

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

~1470

0 / 16Eligibility 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

Immune checkpoint inhibitors, such as anti-PD-1 monoclonal antibodies (e.g., cemiplimab), work by blocking the PD-1 pathway, which cancer cells use to evade the immune system. By inhibiting this pathway, these drugs enhance the immune response against melanoma cells. SAR444245, studied for its antitumor activity, may synergize with cemiplimab to further boost the immune system's ability to target and destroy melanoma cells. This combination is significant for melanoma patients as it represents a potential advancement in treatment efficacy, offering hope for better outcomes.