A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07063212
Phase
PHASE2
Status
Recruiting

Conditions

  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Hypopharynx Cancer
  • Hypopharynx Squamous Cell Carcinoma
  • Larynx Cancer
  • Larynx Squamous Cell Carcinoma
  • Nasal Cavity Cancer
  • Oral Cavity Cancer
  • Oral Squamous Cell Carcinoma
  • Oropharynx Cancer
  • Oropharynx Squamous Cell Carcinoma
  • Sinus Cancer
  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan — DRUG
    Sacituzumab govitecan (SG; Trodelvy®) is a trophoblast cell-surface antigen 2 (Trop-2)- directed antibody-drug conjugate
  • Cetuximab — DRUG
    Cetuximab (also known as ERBITUX®) is an epidermal growth factor receptor (EGFR) antagonist

Study Details

The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and/or metastatic head and neck squamous cell cancer (HNSCC).

Key Dates

Start date
Jul 2, 2025
Status verified
Feb 2026
Primary completion
Jan 2, 2028
Completion
Jan 2, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with recurrent and metastatic head and neck squamous cell carcinoma/HSNCC
    Participants with recurrent and metastatic head and neck squamous cell carcinoma/HSNCC who have progressed after first or second line systemic therapy

Primary Outcome Measure

Objective Response Rate [ Time Frame: up to 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Winston Wong, MD
646-608-4245
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Winston Wong, MD
646-608-4245
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Winston Wong, MD
646-608-4245
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)CommackNew York11725
Winston Wong, MD
646-608-4245
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Winston Wong, MD
646-608-4245
Memorial Sloan Kettering Cancer Center (All Protocol Activites)New YorkNew York10065
Winston Wong, MD
646-608-4245
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Winston Wong, MD
646-608-4245

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