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

Trial Summary

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.

What data supports the effectiveness of the drug cemiplimab in treating 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 ability to fight tumors. It has been approved for use in the USA and Europe based on positive results from clinical trials, where it demonstrated a significant and durable response in patients. ^{1 2 3 4 5}

What makes the drug SAR444881 + Cemiplimab unique for cancer treatment?

SAR444881 combined with Cemiplimab is unique because it involves a novel combination of drugs, where Cemiplimab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. This combination may offer a new approach for treating cancers that do not respond well to existing therapies. ^{6 7 8 9 10}

What is the purpose of this trial?

To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.

Research Team

Aung Naing, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 (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]

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-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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Cemiplimab: First Global Approval. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]

3. New Zealand 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Futibatinib: First Approval. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Initial testing (stage 1) of eribulin, a novel tubulin binding agent, by the pediatric preclinical testing program. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

ABCG2 Overexpression Contributes to Pevonedistat Resistance. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A phase I study of the oral platinum agent satraplatin in sequential combination with capecitabine in the treatment of patients with advanced solid malignancies. [2015]

10. England 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. [2022]