NCT04722523

A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer

Recruiting now Phase 1 Last updated 30 March 2026

What this trial tests

Phase 1 trial testing Cisplatin in Head and Neck Cancer in 40 participants. Currently enrolling.

Timeline

20 January 2021

Primary endpoint
20 June 2026

20 June 2026

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	20 January 2021
Primary completion	20 June 2026
Estimated completion	20 June 2026
Sites	7 locations across United States

Drugs / interventions tested

• Cisplatin (cisplatin) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Docetaxel
• Cetuximab
• Cemiplimab (CEMIPLIMAB) — full drug profile →
• Surgical Resection of Primary +/- Neck Dissection
• Post-operative radiation therapy
• Paclitaxel — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Head Cancer — all drugs for Head Cancer →
• Head Cancer Neck — all drugs for Head Cancer Neck →
• Neck Cancer — all drugs for Neck Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Head and Neck Cancer or Head Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Synergizing radiotherapy and immunotherapy: Current challenges and strategies for optimization.
   Rajeev-Kumar G, Pitroda SP. · · 2023 · cited 22× · PMID 36563632 · DOI 10.1016/j.neo.2022.100867
2. Taxanes in the Treatment of Head and Neck Squamous Cell Carcinoma.
   Hsieh CY, Lin CC, Chang WC. · · 2023 · cited 8× · PMID 38001888 · DOI 10.3390/biomedicines11112887
3. Advancing Head and Neck Cancer Therapies: From Conventional Treatments to Emerging Strategies.
   Mordzińska-Rak A, Telejko I, Adamczuk G, Trombik T, et al · · 2025 · cited 5× · PMID 40426875 · DOI 10.3390/biomedicines13051046
4. Improving Radiotherapy Response in the Treatment of Head and Neck Cancer.
   Wicker CA, Petery T, Dubey P, Wise-Draper TM, et al · · 2022 · cited 5× · PMID 36734873 · DOI 10.1615/critrevoncog.2022044635
5. Neoadjuvant immunotherapy in squamous cell carcinoma of the head and neck: current evidence and future perspectives.
   Zhang B, Tan H, Kuang J, Zhou B, et al · · 2025 · cited 3× · PMID 41214710 · DOI 10.1186/s12943-025-02487-4
6. Anti-programmed death-1 inhibitors and nimotuzumab in combination with induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma: a propensity score-matched analysis.
   Zhang YN, Chen YP, OuYang PY, Lu TX, et al · · 2025 · cited 3× · PMID 39896749 · DOI 10.1177/17588359251316094
7. Synergistic Action of Immunotherapy and Nanotherapy against Cancer Patients Infected with SARS-CoV-2 and the Use of Artificial Intelligence.
   Gupta T, Debele TA, Wei YF, Gupta A, et al · · 2022 · cited 1× · PMID 35008377 · DOI 10.3390/cancers14010213
8. [Application of neoadjuvant immunotherapy in head and neck squamous cell carcinoma: From mechanisms to clinical practice].
   Chen J, Zhang J, Kuang Y, Chen Y, et al · · 2025 · PMID 42032983 · DOI 10.11817/j.issn.1672-7347.2025.250271