Cemiplimab for Colon Cancer

Recruiting at 4 trial locations

Overseen By Michael Overman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antiretrovirals, Chemotherapy, Immunosuppressants, others

Disqualifiers: Congestive heart failure, Angina, Arrhythmia, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cemiplimab, a drug that might help control a specific type of colon cancer known as dMMR (deficient mismatch repair) colon cancer. Researchers aim to determine if this treatment can effectively manage the disease. Participants will receive the drug through an IV every three weeks for up to eight cycles. The trial seeks individuals with dMMR colon cancer who have a primary tumor accessible via a scope and are willing to undergo repeated evaluations. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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, you cannot participate if you are receiving other investigational agents, chemotherapy, or targeted therapy for colon cancer.

Is there any evidence suggesting that cemiplimab is likely to be safe for humans?

Research has shown that cemiplimab has been tested in other cancers, such as skin and lung cancer. In these studies, most patients tolerated cemiplimab well. Common side effects included tiredness, skin rash, and diarrhea. Although less common, serious side effects like infections and liver problems were also reported.

The FDA has already approved cemiplimab for other cancers, indicating it has passed safety checks for those uses. However, this trial specifically tests it for colon cancer, so safety details might differ. Prospective participants should consider this when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about cemiplimab for colon cancer because it works differently than standard treatments like chemotherapy and radiation. Cemiplimab is a type of immunotherapy that helps your immune system recognize and attack cancer cells by targeting a protein called PD-1 on immune cells. This approach is promising because it can potentially result in fewer side effects and offer a more precise attack on cancer cells compared to traditional treatments.

What evidence suggests that cemiplimab might be an effective treatment for colon cancer?

Research has shown that cemiplimab, a type of immunotherapy, may effectively treat colon cancer with certain genetic changes called dMMR (deficient mismatch repair). This drug helps the immune system identify and attack cancer cells. Previous studies found that cemiplimab can improve outcomes for patients with some cancers, such as advanced skin cancer. In other cancer types, combining cemiplimab with chemotherapy has greatly improved long-term survival. These findings suggest that cemiplimab might be a good option for managing colon cancer, especially when the cancer has specific genetic traits. Participants in this trial will receive cemiplimab intravenously over about 30 minutes on Day 1 of each 3-week study cycle, for up to 8 cycles. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael J Overman, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults with localized colon cancer that is dMMR or MSI-H, confirmed by specific tests. They should have a certain level of physical fitness (ECOG 0-1), accessible tumors for endoscopic evaluation, and acceptable blood test results. Women of childbearing potential and men must agree to use contraception during the study and for some time after.

Inclusion Criteria

I am fully active or can carry out light work.

My primary tumor can be reached with an endoscope and I agree to have multiple endoscopic exams.

Willingness to return for follow-up, provide blood specimens, sign informed consent, and comply with trial instructions

Exclusion Criteria

I have not had any recent treatments within the specified timeframes.

I have recovered from previous cancer treatments, except for mild nerve issues or hair loss.

Immunocompromised patients and those known to be HIV positive without undetectable viral load

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemiplimab by vein over about 30 minutes on Day 1 of each 3-week study cycle, up to 8 cycles

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are assessed for organ-sparing rate and non-operative management at 1 year

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab

Trial Overview The trial is testing Cemiplimab's effectiveness in controlling dMMR colon cancer without surgery. Participants will receive this immunotherapy drug to see if it can manage their cancer by enhancing their immune system's ability to fight tumor cells.

How Is the Trial Designed?

Group I: Cemiplimab Experimental Treatment 1 Intervention

Participants will receive cemiplimab by vein over about 30 minutes on Day 1 of each 3-week study cycle, up to 8 cycles.

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+

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

Cetuximab is an effective monoclonal antibody that targets the epidermal growth factor receptor, showing significant clinical efficacy in treating colorectal cancer (CRC) either alone or in combination with chemotherapy.

The combination of cetuximab with chemotherapy is well tolerated, with minimal overlapping toxicities, making it a crucial treatment option for patients with metastatic CRC who do not respond to traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergy between cetuximab and chemotherapy in tumors of the gastrointestinal tract. Mahtani, RL., Macdonald, JS.[2022]

Pucotenlimab is a monoclonal antibody that targets PD-1, effectively blocking its interaction with PD-L1 and PD-L2, which helps restore immune cell function against various solid tumors.

In July 2022, pucotenlimab received conditional approval in China for treating advanced solid tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) characteristics, particularly after previous therapies have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pucotenlimab: First Approval. Dhillon, S.[2022]

Temsirolimus enhances the effectiveness of cetuximab in treating colon cancer by reducing the levels of CIP2A, which helps cancer cells resist treatment, thus making them more susceptible to cetuximab.

The study found that temsirolimus not only inhibits CIP2A transcription but also promotes its degradation, and this mechanism is particularly effective in colon cancer cells without the K-ras codon 12 mutation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temsirolimus enhances the efficacy of cetuximab in colon cancer through a CIP2A-dependent mechanism. Wang, HW., Yang, SH., Huang, GD., et al.[2021]

Cetuximab, when used alongside chemotherapy, has been associated with improved survival rates in patients with metastatic colon cancer.

In a reported case, a patient with metastatic colon cancer developed a rare condition called paraneoplastic necrotizing myopathy, which showed possible improvement with cetuximab treatment, even though the cancer itself did not respond to the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can cetuximab affect paraneoplastic myopathy? Galani, E., Bonakis, A., Christodoulou, C., et al.[2021]

In a phase I/II trial involving 55 patients with metastatic colorectal cancer, the combination of napabucasin and pembrolizumab showed promising antitumor activity, particularly in patients with microsatellite instability high (MSI-H) tumors, achieving an immune-related objective response rate (irORR) of 50%.

The treatment was generally well-tolerated, with no dose-limiting toxicities observed at the recommended phase 2 dose of napabucasin (480 mg), although the overall efficacy did not meet the primary endpoint, highlighting the need for further investigation into biomarkers that may influence treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Phase I/II Trial of Napabucasin and Pembrolizumab in Patients with Metastatic Colorectal Cancer (EPOC1503/SCOOP Trial). Kawazoe, A., Kuboki, Y., Shinozaki, E., et al.[2021]

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 ... Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05749

Cemiplimab for the Treatment of Localized dMMR Colon ... This phase II trial tests how well cemiplimab works in treating colon cancer that has not spread to other parts of the body (localized) with mutations.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07058012

NCT07058012 | A Phase II Platform Study to Evaluate ... The NSABP FC-13 study is being done to determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11268751/

Real-World Treatment Patterns and Outcomes of Cemiplimab ... Most cases of CSCC are cured by surgery/radiation, but an estimated 1% to 5% of patients will develop advanced disease, which is associated with ...

5. cancerletter.com cancerletter.com/clinical-roundup/20240531_7i/

REGN7075 + Libtayo leads to anti-tumor responses in ... Oxaliplatin-based chemotherapy significantly improves survival only in stage 3 colorectal cancer patients aged 70 or younger, according to a ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/761097s016lbl.pdf

LIBTAYO® (cemiplimab-rwlc) injection, for intravenous use Study 1423. In 26 patients with advanced CSCC treated with LIBTAYO in Study 1423 [see Clinical Studies. (14.1)], safety data were consistent with those ...

7. aetna.com aetna.com/cpb/medical/data/900_999/0942.html

Cemiplimab-rwlc (Libtayo) - Medical Clinical Policy Bulletins On November 8, 2022, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adult ...

8. ema.europa.eu ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf

Libtayo, INN-cemiplimab - EMA Basal Cell Carcinoma. LIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/cemiplimab-rwlc-intravenous-route/description/drg-20444105

Cemiplimab-rwlc (intravenous route) - Side effects & uses Cemiplimab-rwlc is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by ...

10. libtayo.com libtayo.com/high-risk-cscc/study-results

LIBTAYO® (cemiplimab-rwlc) Study Results | High-Risk CSCC Discover study results and possible side effects of the adjuvant treatment of LIBTAYO® (cemiplimab-rwlc) in adults with high-risk CSCC.