Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04722523 · ClinicalTrials.gov registry record · Phase 1
A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer
A Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 7
- Study locations
NCT04722523: Recruiting Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04722523 is a Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 40 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (85% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722523, a Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
The primary endpoint is safety and tolerability, which will be evaluated by a description of observed adverse events by grades. All toxicities will be graded according to NCI CTCAE, Version5.0. The regimen will be deemed safe and well tolerated if there are 2 or fewer DLTs out of 10 patients enrolled. A DLT is defined as any non-hematologic grade 3 or greater adverse event as defined by CTCAE v5.0 that is thought to be related to the addition of Cemiplimab to the combination of a platinum-double
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Cemiplimab
- DRUG Cisplatin
- DRUG Cetuximab
Study Locations (7)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) - Rockville Centre
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2026-06-20 |
| Phase | Phase 1 |
What NCT04722523 shows while recruiting
NCT04722523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (85% lower).
The record links to 6 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04722523 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04722523 about?
NCT04722523 is a clinical study titled "A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer". 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...
What is the current status of trial NCT04722523?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-01-20. Estimated completion is 2026-06-20.
What conditions does trial NCT04722523 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, HNSCC, Neck Cancer, Head Cancer.
What interventions are being tested in trial NCT04722523?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Cemiplimab (DRUG), Cisplatin (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT04722523?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04722523 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04722523's enrollment target sits among peer trials
40 142nd of 250 higher than 99 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
RECRUITING · Phase 1
-
RAPA-201 Therapy of Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
RECRUITING · Phase 1
-
TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers
RECRUITING · Phase 1
-
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI