Cemiplimab + CDX-1140 for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, Prednisone

Disqualifiers: Autoimmune disease, Organ transplant, 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: 10

Duration: 4-5 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with stage III-IV head and neck cancer. It compares the effects of using cemiplimab alone or with another drug, CDX-1140, before surgery. Both are monoclonal antibodies, proteins designed to help the immune system fight cancer more effectively. Participants may qualify if they have head and neck cancer not caused by HPV and require surgery. 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 requires that you stop using immunosuppressive medications at least 14 days before starting the study drugs. If you are taking prednisone at a dose of 10 mg or more, you will also need to stop. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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

Research shows that cemiplimab is generally well-tolerated by patients. In previous studies, it helped the immune system fight cancer. Some side effects, such as tiredness, skin rash, and diarrhea, can occur but are often manageable.

For CDX-1140, studies indicate it is safe. It did not cause strong immune reactions in animal tests, which suggests positive implications for human safety. Patients receiving both cemiplimab and CDX-1140 might experience more side effects since both are immunotherapy drugs. However, trials have tested the combination without major safety concerns.

These treatments are in a phase 2 trial, meaning they have passed initial safety tests, but more research is needed to fully understand their safety when used together. Always consult your doctor about any concerns or questions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for head and neck cancer, which typically involves surgery and radiation, the investigational treatments cemiplimab and CDX-1140 offer a novel approach. Cemiplimab is an immunotherapy drug that helps the immune system better recognize and attack cancer cells, providing a targeted mechanism of action. CDX-1140 is another immune-based treatment that enhances the body's own defense against cancer. Researchers are excited about these treatments because they could potentially improve outcomes by making the immune system more effective against the cancer, leading to better control and possibly fewer side effects compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for head and neck cancer?

Research shows that cemiplimab, a monoclonal antibody, helps the immune system identify and attack cancer cells, which can shrink tumors. Studies have found that cemiplimab can slow cancer spread, particularly in challenging skin cancer cases. In this trial, some participants will receive cemiplimab alone, while others will receive a combination of cemiplimab and CDX-1140. CDX-1140, another monoclonal antibody, boosts the immune system and might enhance cemiplimab's effectiveness by further inhibiting tumor growth. Early research suggests that using CDX-1140 with cemiplimab before surgery could reduce tumor size, potentially preserving more healthy tissue during head and neck cancer surgery. Overall, this combination is being studied for its potential to improve outcomes in advanced cancer cases. ^{1 3 4 6 7}

Who Is on the Research Team?

Matin Imanguli

Principal Investigator

JHU Sidney Kimmel Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for patients with stage III-IV head and neck cancer suitable for surgery. Eligible participants must have certain blood counts, a specific type of non-HPV related oropharyngeal cancer, measurable disease, and be in good enough health to perform daily activities. They should not have received prior treatments that would exclude them.

Inclusion Criteria

My bilirubin levels are within the normal range.

My oropharyngeal cancer is not related to HPV.

I have a tumor that can be measured with imaging or physical exam.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients receive cemiplimab and/or CDX-1140 intravenously, followed by surgical resection and standard of care adjuvant therapy

4-5 weeks

Multiple visits for treatment and surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up visits at week 9-10, week 18, at 6 months, and every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• CDX-1140
• Cemiplimab

Trial Overview The study tests if combining Cemiplimab (an immune system booster) with CDX-1140 (another antibody) before surgery is more effective than using Cemiplimab alone in shrinking tumors in head and neck cancer patients.

How Is the Trial Designed?

Group I: Arm II (CDX-1140 and cemiplimab) Experimental Treatment 7 Interventions

Patients receive CDX-1140 IV over 90 minutes on day 1 and cemiplimab IV over 30 minutes on day 4. Patients then undergo standard of care surgical resection on day 29-36 and receive standard of care adjuvant therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET during screening and tumor biopsy and blood sample collection throughout the study.

Group II: Arm I (Cemiplimab) Active Control 5 Interventions

Patients receive cemiplimab IV over 30 minutes on day 1. Patients then undergo standard of care surgical resection on day 29-36 and receive standard of care adjuvant therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET during screening and tumor biopsy and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06980038

NCT06980038 | Testing Whether Cemiplimab (REGN2810 ... Giving cemiplimab and CDX-1140 versus cemiplimab alone before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be ...

2. 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 ...

3. dctd.cancer.gov dctd.cancer.gov/research/networks/etctn/head-neck-trials.pdf

Head and Neck/Thyroid Cancer Anti-CD40 Antibody CDX-1140 and Cemiplimab in AJCC Stage. III-IV Head and Neck Cancer Patients Prior to Surgery. 10721. II. Neoadjuvant Chemotherapy with or ...

4. synapse.patsnap.com synapse.patsnap.com/drug/242ddf55e4c04ae2bf0988167a21e518

CDX-1140 - Drug Targets, Indications, Patents These data support the potential of CDX-1140 as part of a cancer therapy regimen, and a phase 1 trial has recently commenced.

5. mdpi.com mdpi.com/2072-6694/12/11/3377

Tumor Microenvironment and Immunotherapy Response in ... In another phase I study, the CD40 agonist CDX-1140 is being evaluated as monotherapy or in combination with pembrolizumab, chemotherapy or the recombinant fms- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40921630/

Randomized clinical efficacy and safety study of ... Patients and methods: In a randomized phase 2 trial, we evaluated the efficacy and safety of peltopepimut-S plus cemiplimab compared with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04722523

NCT04722523 | A Study of Cemiplimab With ... The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and ...