Cemiplimab + Fianlimab for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Eric Christenson, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Chronic steroids

Disqualifiers: Autoimmune disease, Heart disease, Metastatic cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on chronic systemic steroids or require other cancer treatments while participating.

How is the drug Cemiplimab + Fianlimab unique for colorectal cancer?

Cemiplimab + Fianlimab is unique for colorectal cancer as it combines two immune checkpoint inhibitors, which may offer a novel approach for patients with microsatellite stable (MSS) colorectal cancer, a group that typically does not respond well to existing immune therapies.

^{1 2 3 4 5}

Eligibility Criteria

This trial is for patients aged 70 or older with localized or locally advanced colorectal cancer that's microsatellite instability-high (MSI-H). Specific eligibility details are not provided, but typically participants must be in good health aside from their cancer and meet certain lab criteria.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent document

I am 70 years old or older.

I agree to undergo endoscopic and CT scans for 2 years.

Exclusion Criteria

Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

I won't need other cancer treatments during the study.

I have been treated with specific immune therapies before my colorectal cancer diagnosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemiplimab with or without fianlimab to evaluate safety and clinical activity

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

Participant Groups

The study is testing the effectiveness and safety of cemiplimab alone, versus a combination of cemiplimab with fianlimab. It aims to see how well these treatments work in older adults with a specific type of colorectal cancer.

Group I: Cohort B - Cemiplimab with Fianlimab Experimental Treatment 2 Interventions

Group II: Cohort A - Cemiplimab Experimental Treatment 1 Intervention

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins SKCCC Baltimore, MD

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Lead Sponsor

Regeneron Pharmaceuticals Industry Sponsor

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Adjuvant therapy of colon carcinoma]. [2008] In patients with stage III carcinoma of the colon, adjuvant chemotherapy is indicated after R0 resection. No age limitations exist. Combination chemotherapy with FOLFOX4 or (if oxaliplatin is contraindicated) monotherapy with a fluoropyrimidine, preferably capecitabine, can be regarded as the standard treatment. Because of its unfavorable toxicity profile, the 5-FU/folic acid bolus scheme (the Mayo scheme) should no longer be used, and combinations including irinotecan also do not play a part in colon carcinoma. The combination XELOX (oxaliplatin + capecitabine) is currently being studied in phase III trials. Data on the efficacy of the targeted drugs bevacizumab and cetuximab cannot be expected until at least 2010/2011. It is important that adjuvant treatment be started in a timely manner, within 8 weeks of surgery. As far as stage II disease is concerned, adjuvant chemotherapy analogous to that for stage III should be considered in high-risk patients (T4, emergency surgery, tumor perforation/tear,

2. Switzerland pubmed.ncbi.nlm.nih.gov

Microsatellite stable metastatic colorectal cancer without liver metastasis may be preferred population for regorafenib or fruquintinib plus sintilimab as third-line or above therapy:A real-world study. [2022] The antitumor activity of nivolumab plus regorafenib in colorectal cancer from a phase Ib REGONIVO study is encouraging. The present study was conducted to evaluate the efficacy and safety of regorafenib or fruquintinib plus sintilimab as third-line or above therapy in patients with microsatellite stable (MSS) metastatic colorectal cancer.

3. Greece pubmed.ncbi.nlm.nih.gov

Regorafenib-to-trifluridine/tipiracil Versus the Reverse Sequence for Refractory Metastatic Colorectal Cancer Patients: A Multicenter Retrospective Real-life Experience. [2021] Regorafenib (REG) and trifluridine/tipiracil (FTD/TPI) have have been shown to improve overall survival in patients with refractory metastatic colorectal cancer. The aim of our study was to evaluate the efficacy and safety profiles of these agents administered in sequence in real world practice.

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

Primary and Acquired Resistance of Colorectal Cancer to Anti-EGFR Monoclonal Antibody Can Be Overcome by Combined Treatment of Regorafenib with Cetuximab. [2022] In colorectal cancer, the activation of the intracellular RAS-RAF and PIK3CA-AKT pathways has been implicated in the resistance to anti-EGFR mAbs. We have investigated the role of regorafenib, an oral multikinase inhibitor, in combination with cetuximab, an anti-EGFR mAb, to overcome anti-EGFR resistance.

5. Egypt pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Regorafenib Combined with Toripalimab in the Third-Line and beyond Treatment of Advanced Colorectal Cancer. [2022] The most effective treatment of immune checkpoint inhibitors (ICIs) is restricted in microsatellite instability (MSI-H) subsets of advanced colorectal cancer, but MSI-H only accounts for 4-5% among them. ICIs are completely ineffective in advanced colorectal cancer patients with microsatellite stable (MSS), according to literatures published. Regorafenib is a novel tyrosine kinase inhibitor (TKIs) that could normalize tumor blood vessels by inhibiting vascular endothelial growth factor receptor and its downstream, thus improving cytotoxic T cell infiltration in tumor microenvironment, which has a synergistic effect with ICIs. Toripalimab is a type of anti-PD-1 monoclonal antibody produced by Junshi Biosciences in China. Herein, we aimed to explore the efficacy and safety of regorafenib combined with toripalimab in the third-line and beyond treatment of advanced colorectal cancer.