NCT04722523 A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer
| NCT ID | NCT04722523 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-01-20 |
| Primary Completion | 2026-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2021-01-20 with a primary completion date of 2026-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.
Eligibility Criteria
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx * Clinical stage T1, N2-3; T2, N1-3, T3/T4a, Any N (AJCC, 8th ed.) without evidence of distant metastasis (M0) based on PET/CT or CT chest, abdomen, and pelvis, for which standard-of-care treatment would entail surgical resection with adjuvant radiation +/- chemotherapy. ° Patients with recurrent and multiple primary head and neck cancers that are surgically resectable are eligible if the patient did not receive prior radiation or systemic therapy. * Disease must be amenable to surgical resection. * The patient must be a surgical candidate. 1. Hemoglobin \> 9.0 g/dL 2. Absolute neutrophil count (ANC) \>1.5 x 10\^9/L 3. Platelet count \>100 x 10\^9/L 4. Serum creatinine \<1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) \>30
Frequently Asked Questions
Who can join the NCT04722523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04722523 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04722523 currently recruiting?
Yes, NCT04722523 is actively recruiting participants. Visit ClinicalTrials.gov or contact Memorial Sloan Kettering Cancer Center to inquire about joining.
Where is the NCT04722523 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 1 additional location.
Who is sponsoring the NCT04722523 clinical trial?
NCT04722523 is sponsored by Memorial Sloan Kettering Cancer Center. The trial plans to enroll 40 participants.
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