SAR444881 + Cemiplimab for Cancer

Overseen By Aung Naing, Md

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Corticosteroids, Immunosuppressants, others

Disqualifiers: Autoimmune disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the new treatment, SAR444881, works alone and in combination with cemiplimab (an immunotherapy drug) to combat solid tumors. The researchers aim to identify biomarkers (signals) that indicate the treatment's impact on cancer. Individuals with advanced or metastatic cancers, such as non-small cell lung cancer, colorectal cancer, or ovarian cancer, who have not previously undergone certain therapies, may be suitable candidates, particularly if they have a tumor that can be safely biopsied (sampled for testing). As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions a 'washout period' for certain therapies, which means you might need to stop some treatments before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, the combination of SAR444881 and cemiplimab was generally well-tolerated by patients. Research has shown that cemiplimab, when combined with chemotherapy, provides significant survival benefits for patients with certain types of lung cancer, suggesting its safety with other treatments. While detailed safety information for SAR444881 alone is not yet available, the ongoing Phase 2 trial examines both the safety and effectiveness of the SAR444881 and cemiplimab combination. This phase typically involves closely monitoring side effects and patient tolerance. So far, no major issues have been reported, indicating the treatment may be safe for further testing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for cancer, which often rely on chemotherapy or radiation, SAR444881 combined with cemiplimab offers a new approach by harnessing the power of immunotherapy. SAR444881 is a novel agent potentially enhancing the immune system's ability to target cancer cells more effectively. Cemiplimab is a PD-1 inhibitor that helps the immune system recognize and attack cancer cells. Researchers are excited about this combination because it could lead to more targeted and potentially less toxic cancer treatment options, offering hope for better outcomes.

What evidence suggests that SAR444881 and cemiplimab could be effective for cancer?

Studies have shown that cemiplimab effectively treats certain cancers, such as advanced squamous cell carcinoma, a type of skin cancer. It aids the immune system in fighting cancer cells. When combined with chemotherapy, cemiplimab has significantly improved survival rates for patients with advanced non-small cell lung cancer. In this trial, participants will receive SAR444881 alone during Cycle 1, followed by both SAR444881 and cemiplimab starting from Cycle 2. Although less information exists about SAR444881, the trial aims to evaluate its effects alone initially and then in combination with cemiplimab in solid tumors. Researchers are studying this combination to understand its potential to improve outcomes for cancer patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Aung Naing, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults with advanced solid tumors, including specific types like NSCLC and ovarian cancer. They must be willing to undergo biopsies, have a life expectancy of at least 3 months, and use contraception if of childbearing potential. Excluded are those with certain psychiatric disorders, autoimmune diseases, other cancers requiring treatment, or prior adverse reactions to similar drugs.

Inclusion Criteria

Ability to understand and willingness to sign an informed consent form (ICF) prior to initiation of the study and any study procedures

Willing to undergo mandatory biopsies and blood collections as required by the study

Life expectancy 3 months

Exclusion Criteria

Participants who are receiving any other investigational agents

Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study

I have an autoimmune disease, but it might be one of the exceptions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAR444881 and cemiplimab. SAR444881 is administered on Day 1 of each cycle, and cemiplimab is added starting from Cycle 2.

1 year

Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• SAR444881

Trial Overview The trial is testing SAR444881 in combination with Cemiplimab for effectiveness against solid tumors. It aims to identify biomarkers related to the treatment's performance. Participants will receive both medications and undergo regular biopsies and blood tests.

How Is the Trial Designed?

Group I: Treatment with SAR444881 and Cemiplimab Experimental Treatment 2 Interventions

SAR444881 will be given by vein over about 60 minutes on Day 1 of each cycle. Cemiplimab will be administered by vein over about 30 minutes on Day 1 of each cycle, starting with Cycle 2. During Cycle 1, you will only receive SAR444881. Starting on Day 1 of Cycle 2 and for all other cycles, you will receive both SAR444881 and cemiplimab.

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

Approved in European Union as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in United States as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Basal cell carcinoma (BCC)
• Non-small cell lung cancer (NSCLC)

Approved in Canada as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

Cemiplimab-rwlc is a newly approved PD-1/L1 inhibitor for first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, either alone or with chemotherapy.

This review highlights the differences in patient populations studied for cemiplimab compared to other treatments, emphasizing its role in expanding options for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. Ahn, J., Nagasaka, M.[2023]

Cemiplimab is a PD-1 monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which is crucial for enhancing the immune response against cancer cells.

In September 2018, cemiplimab received FDA approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma who cannot undergo curative surgery or radiation, marking a significant advancement in cancer treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab: First Global Approval. Markham, A., Duggan, S.[2023]

Cemiplimab-rwlc is the first systemic treatment approved by the US FDA for patients with advanced cutaneous squamous cell carcinoma (CSCC) who cannot undergo curative surgery or radiation, highlighting its significance in treating this aggressive cancer.

The CASE study is a Phase IV, noninterventional study designed to gather real-world data on the clinical characteristics and survivorship of patients receiving cemiplimab, aiming to enhance understanding of its effectiveness and patient outcomes in everyday clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. Migden, MR., Chandra, S., Rabinowits, G., et al.[2020]

Cemiplimab (Libtayo®) is the first approved immunotherapy for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who cannot undergo surgery or radiotherapy, showing a clinically significant objective response rate in the phase II EMPOWER-CSCC 1 trial.

The treatment has a durable effect, with the median duration of response and overall survival not yet reached, and it has an acceptable safety profile, with manageable immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. Lee, A., Duggan, S., Deeks, ED.[2020]

Futibatinib is an oral medication that irreversibly inhibits fibroblast growth factor receptors (FGFR1-4) and has been approved for treating adult patients with unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusions or rearrangements.

The drug was officially approved in the USA on September 30, 2022, marking a significant milestone in its development for various cancers, including cholangiocarcinoma, breast cancer, and others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Futibatinib: First Approval. Syed, YY.[2022]

Futibatinib, an FGFR inhibitor, was found to have manageable safety and pharmacodynamic activity in a phase I trial involving 86 patients with advanced solid tumors, with a recommended phase II dose of 20 mg once daily.

The trial showed that 5 patients had partial responses to futibatinib, particularly in those with FGFR aberrations, and 41 patients (48%) experienced stable disease, indicating potential efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors. Bahleda, R., Meric-Bernstam, F., Goyal, L., et al.[2022]

Cemiplimab-rwlc (Libtayo) is an FDA-approved immunotherapy for advanced cutaneous squamous cell carcinoma (CSCC) that works by blocking the PD-1 receptor, enhancing the immune system's ability to fight tumors.

Clinical trials have shown that cemiplimab is effective in treating CSCC, although common side effects and safety issues were noted, highlighting the need for ongoing research to improve treatment outcomes and reduce toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. Ahmed, SR., Petersen, E., Patel, R., et al.[2019]

Citations

1. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-plus-chemotherapy-results-five-years

Libtayo® (cemiplimab) Plus Chemotherapy Results at Five ... The five-year probability of survival was 19.4% for the Libtayo combination versus 8.8% for chemotherapy. 8.2-month median progression-free ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06651593

NCT06651593 | Phase II Biomarker Study of SAR444881 ... To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.

3. targetedonc.com targetedonc.com/view/cemiplimab-plus-chemo-shows-5-year-nsclc-survival-benefit

Cemiplimab Plus Chemo Shows 5-Year NSCLC Survival ... New 5-year data reveals cemiplimab plus chemotherapy significantly enhances survival rates for advanced non-small cell lung cancer patients.

4. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-combination-platinum-based-chemotherapy-non-small-cell-lung-cancer

FDA approves cemiplimab-rwlc in combination with ... The main efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were progression-free survival (PFS) and ...

5. withpower.com withpower.com/trial/phase-2-neoplasms-3-2025-2bf70

SAR444881 + Cemiplimab for Cancer Cemiplimab has been shown to be effective in treating advanced cutaneous squamous cell carcinoma (a type of skin cancer) by enhancing the immune system's ...

6. libtayohcp.com libtayohcp.com/nsclc/efficacy/combination-therapy/patient-reported-outcomes

Patient-reported outcomes - LIBTAYO® (cemiplimab-rwlc) View the statistical analysis of patient reported outcomes of NSCLC treatment with LIBTAYO® + chemotherapy vs. placebo + chemotherapy.