Sacituzumab Govitecan + Cetuximab for Throat Cancer

Recruiting at 6 trial locations

Overseen By Winston Wong, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Topoisomerase inhibitors

Disqualifiers: Severe allergies, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of two drugs, sacituzumab govitecan (an antibody-drug conjugate) and cetuximab (a monoclonal antibody), is effective and safe for treating advanced head and neck cancer. The focus is on individuals whose cancer has returned or spread after other treatments. It is suitable for those with squamous cell carcinoma in areas such as the throat or mouth, where cancer has progressed despite previous therapies. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have had certain cancer treatments within two weeks before starting the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that sacituzumab govitecan in combination with cetuximab is likely to be safe for humans?

Research has shown that sacituzumab govitecan may help treat advanced head and neck squamous cell carcinoma (HNSCC), even in patients who have tried several other treatments. However, it is not officially approved for head and neck cancer, and warnings exist about side effects like low white blood cell counts.

Cetuximab is already used to treat recurring or spreading squamous cell carcinoma of the head and neck, especially when other treatments haven't worked. Studies have shown it can cause side effects like skin rash, which may also indicate that the drug is working.

Both drugs are used in cancer treatments, but they come with some risks. Participants should consider these possible side effects and consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Sacituzumab Govitecan combined with Cetuximab for treating throat cancer because these treatments offer new ways to attack the disease. Sacituzumab Govitecan is unique because it uses an antibody-drug conjugate to deliver a powerful chemotherapy agent directly to cancer cells, minimizing damage to healthy cells. Cetuximab, on the other hand, targets a specific protein on cancer cells called EGFR, which helps stop the cells from growing and spreading. Unlike the traditional standard of care, which generally involves surgery, radiation, and chemotherapy, this combination targets cancer cells more precisely and could potentially lead to better outcomes for patients with recurrent and metastatic head and neck squamous cell carcinoma.

What evidence suggests that sacituzumab govitecan and cetuximab might be an effective treatment for throat cancer?

Research has shown that sacituzumab govitecan may help treat patients with advanced head and neck squamous cell carcinoma (HNSCC) who have already received treatment. Some patients have experienced significant improvement, particularly if their cancer returned or spread. Sacituzumab govitecan delivers a drug that directly kills cancer cells. In contrast, cetuximab targets a specific protein on cancer cells and has proven effective in treating various cancers, including those in the head and neck. This trial will evaluate the combination of sacituzumab govitecan and cetuximab, which might enhance their effectiveness, offering a potential option for individuals with recurring or spreading HNSCC. ^{6 7 8 9 10}

Who Is on the Research Team?

Winston Wong, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with recurrent or metastatic head and neck squamous cell cancer (HNSCC), including cancers of the throat, larynx, mouth, hypopharynx, oropharynx, sinonasal area, and nasopharynx. Specific eligibility criteria are not provided but typically include factors like age range, overall health status, and previous treatments received.

Inclusion Criteria

Measurable disease per RECIST v1.1 criteria

International Normalized Ratio (INR) or Prothrombin Time (PT) within normal range

Activated Partial Thromboplastin Time (aPTT) within normal range

Exclusion Criteria

I have had more than 2 treatments for my condition.

I have had severe reactions to EGFR antibody therapy.

I am not using herbal remedies that affect organ function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab govitecan in combination with cetuximab

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cetuximab
• Sacituzumab Govitecan

Trial Overview The study is testing the effectiveness and safety of combining two drugs: Sacituzumab Govitecan and Cetuximab. It aims to determine if this combination can be a new treatment option for patients with HNSCC who have seen their cancer return or spread.

How Is the Trial Designed?

Group I: Participants with recurrent and metastatic head and neck squamous cell carcinoma/HSNCC Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07063212

NCT07063212 | A Study of Sacituzumab Govitecan in ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12108840/

A Case Report of Remarkable Response to Sacituzumab ... A case report of remarkable response to Sacituzumab Govitecan following molecular and functional characterization.

3. aacrjournals.org aacrjournals.org/clincancerres/article/31/5/832/751941/Sacituzumab-Govitecan-in-Patients-with-Relapsed

Sacituzumab Govitecan in Patients with Relapsed/Refractory ... We provide evidence of usefulness of SG in the treatment of patients with advanced head and neck squamous cell carcinoma previously treated with ...

4. mskcc.org mskcc.org/cancer-care/clinical-trials/25-094

A Phase 2 Study of Sacituzumab Govitecan Plus ... The people in this study have squamous cell cancer of the head and neck. Their cancer came back or spread after prior treatment. Sacituzumab govitecan is an ...

5. withpower.com withpower.com/trial/phase-2-larynx-squamous-cell-carcinoma-6-2025-1a6d7

Sacituzumab Govitecan + Cetuximab for Throat Cancer This trial is for individuals with recurrent or metastatic head and neck squamous cell cancer (HNSCC), including cancers of the throat, larynx, mouth, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18481809/

Overview of the efficacy of cetuximab in recurrent and/or ... Safety data considered were only those from the cetuximab studies. Results: Over the 3 cetuximab trials, overall response rates from 10% to 13% ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa0802656

Platinum-Based Chemotherapy plus Cetuximab in Head ... Cetuximab is effective in recurrent or metastatic squamous-cell carcinoma of the head and neck that progresses despite platinum-containing therapy.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842821002122

Cetuximab in locally advanced head and neck squamous ... The current use of cetuximab in LA-HNSCC is limited to cisplatin-unfit patients. · Cetuximab-induced rash toxicity has been associated with efficacy in LA-HNSCC.

9. aacrjournals.org aacrjournals.org/clincancerres/article/31/13/2617/763087/INTERLINK-1-A-Phase-III-Randomized-Placebo

INTERLINK-1: A Phase III, Randomized, Placebo-Controlled ... INTERLINK-1 was a phase III study that evaluated the efficacy and safety of monalizumab plus cetuximab versus placebo plus cetuximab in ...

10. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/pdf/10.1002/cncr.23442

Overview of the efficacy of cetuximab in recurrent and/or ... Safety data considered were only those from the cetuximab studies. and disease control rates from 46% to 56% were observed. The median time to ...