NCT04862650

Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Active, enrolled Phase 2 Last updated 10 February 2026

What this trial tests

Phase 2 trial testing Carboplatin in Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 in 46 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 November 2021

Primary endpoint
31 May 2026

31 December 2026

Quick facts

Lead sponsor	Marcelo Bonomi
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	30 November 2021
Primary completion	31 May 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Carboplatin (Carboplatin) — full drug profile →
• Cemiplimab (CEMIPLIMAB) — full drug profile →
• Paclitaxel — full drug profile →

Conditions studied

• Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 — all drugs for Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 →
• Metastatic Head and Neck Squamous Cell Carcinoma — all drugs for Metastatic Head and Neck Squamous Cell Carcinoma →
• Metastatic Hypopharyngeal Squamous Cell Carcinoma — all drugs for Metastatic Hypopharyngeal Squamous Cell Carcinoma →
• Metastatic Laryngeal Squamous Cell Carcinoma — all drugs for Metastatic Laryngeal Squamous Cell Carcinoma →

Sponsor

Marcelo Bonomi

Who can join

18 and older, any sex, with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 or Metastatic Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.

Publications & conference data

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

1. Combination therapy with oncolytic viruses and immune checkpoint inhibitors in head and neck squamous cell carcinomas: an approach of complementary advantages.
   Dong H, Li M, Yang C, Wei W, et al · · 2023 · cited 35× · PMID 36604694 · DOI 10.1186/s12935-022-02846-x
2. Head and neck cancer: pathogenesis and targeted therapy.
   Liu Y, Zhang N, Wen Y, Wen J. · · 2024 · cited 21× · PMID 39170944 · DOI 10.1002/mco2.702
3. Radiotherapy, Chemotherapy and Immunotherapy-Current Practice and Future Perspectives for Recurrent/Metastatic Oral Cavity Squamous Cell Carcinoma.
   Melo-Alvim C, Neves ME, Santos JL, Abrunhosa-Branquinho AN, et al · · 2022 · cited 20× · PMID 36611391 · DOI 10.3390/diagnostics13010099
4. Overcoming Resistance to Standard-of-Care Therapies for Head and Neck Squamous Cell Carcinomas.
   Gauss C, Stone LD, Ghafouri M, Quan D, et al · · 2024 · cited 10× · PMID 38920648 · DOI 10.3390/cells13121018
5. Therapeutic Advances and Challenges for the Management of HPV-Associated Oropharyngeal Cancer.
   Muniz IAF, Araujo M, Bouassaly J, Farshadi F, et al · · 2024 · cited 4× · PMID 38612819 · DOI 10.3390/ijms25074009