A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy
1 other identifier
interventional
40
1 country
7
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2025
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2025
CompletedFirst Submitted
Initial submission to the registry
July 3, 2025
CompletedFirst Posted
Study publicly available on registry
July 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 2, 2028
February 19, 2026
February 1, 2026
2.5 years
July 3, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
To evaluated objective response rate (ORR; complete response \[CR\] + partial response \[PR\]), by RECIST v1.1, in the study cohort.
up to 2 years
Study Arms (1)
Participants with recurrent and metastatic head and neck squamous cell carcinoma/HSNCC
EXPERIMENTALParticipants with recurrent and metastatic head and neck squamous cell carcinoma/HSNCC who have progressed after first or second line systemic therapy
Interventions
Sacituzumab govitecan (SG; Trodelvy®) is a trophoblast cell-surface antigen 2 (Trop-2)- directed antibody-drug conjugate
Cetuximab (also known as ERBITUX®) is an epidermal growth factor receptor (EGFR) antagonist
Eligibility Criteria
You may qualify if:
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. Other sites not listed will be subject to PI discretion.
- Advanced disease (Stage IV or M1 disease) not amenable to curative local therapy with surgery and/or radiation based approaches
- Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial
- HPV status for oropharynx primary must be previously confirmed or can be performed on available archival or fresh biopsy via p16 immunohistochemistry or HPV specific testing via PCR or RNA ISH. Patients are able to enroll and initiate treatment so long as this is in progress. Exceptions may be made after discussion and review with P.I.
- Have measurable disease per RECIST v1.1 criteria. Tumor lesions situated in previously radiated area may be utilized if they are measurable and progression has been demonstrated in these lesions.
- Male or female patients 18 years of age or older on the day of consent.
- ECOG Performance Status of 0 to 1.
- Adequate hematologic function within 30 days prior to registration, defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 9.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable
- Adequate renal function within 30 days prior to registration, defined as follows:
- o Serum creatinine \< 2.0 x upper limit of normal (ULN) or creatinine clearance (CCr)
- ≥ 30 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male)
- Adequate hepatic function within 30 days prior to registration, defined as follows:
- +21 more criteria
You may not qualify if:
- Patients must not have received more than 2 prior line of systemic treatment (i.e. in the second or third line of treatment) in the recurrent/metastatic setting.
- o Ambiguity regarding lines of treatment a patient has received will be subject to PI review and approval.
- Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge based on assessment by PI and/or consultation with allergy/immunology.
- Patients who have previously received topoisomerase I inhibitors for HNSCC
- Patients who have a confirmed or suspected diagnosis (subject to P.I. discretion) of Gilbert's Syndrome
- Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.
- Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this criterion and may qualify for the study.
- Note: If subjects underwent major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study drug.
- Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis which must be recovered, \< Grade 1) related to immunotherapy and/or radiation treatment that are long lasting, but stable on treatment and not requiring agents that are excluded by this protocol may qualify for the study.
- Patients with simultaneous primary cancers aside from HNSCC will be excluded unless otherwise approved by PI.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate for the malignancy treated at 5 years is estimated to be 90% or greater, unless otherwise approved by PI
- Severe, active co-morbidity defined as the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Gilead Sciencescollaborator
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Winston Wong, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2025
First Posted
July 14, 2025
Study Start
July 2, 2025
Primary Completion (Estimated)
January 2, 2028
Study Completion (Estimated)
January 2, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.