Berzosertib + Chemotherapy + Radiation for Head and Neck Cancer

Recruiting at 20 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, CYP3A4 inducers

Disqualifiers: Nasopharyngeal carcinoma, Brain metastases, others

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

Compensation: Varies

Number of Visits: 2

Duration: 7 weeks

43 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of berzosertib (M6620) when given together with cisplatin and radiation therapy in treating patients with head and neck squamous cell carcinoma that has spread from where it started to nearby tissue or lymph nodes (locally advanced). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving M6620 together with cisplatin and radiation therapy may work better in treating patients with locally advanced head and neck squamous cell carcinoma.

Who Is on the Research Team?

Taofeek K Owonikoko

Principal Investigator

JHU Sidney Kimmel Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

Adults with locally advanced head and neck squamous cell carcinoma, not suitable for surgery, can join this trial. They must have a life expectancy over 3 months, measurable disease, normal organ function tests, and agree to use contraception. Excluded are those with certain other health conditions or treatments that could interfere with the study.

Inclusion Criteria

You have neck cancer where the original source is unknown, regardless of HPV/p16 status.

Patients must have histologically or cytologically confirmed head and neck squamous cell cancer (HNSCC) including paranasal sinus cancers but excluding nasopharyngeal carcinomas

Clinical staged III or IV HNSCC, according to American Joint Committee on Cancer (AJCC) 7th Edition, that is not amenable to surgical resection

Exclusion Criteria

You cannot be taking any other experimental drugs or treatments.

You have a medical condition that is not well controlled or managed.

You cannot participate if you have nasopharyngeal carcinoma, skin squamous cell carcinoma (SCC), or salivary gland carcinomas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive berzosertib, cisplatin, and radiation therapy. Berzosertib is administered IV over 60 minutes on day -7 and then weekly on day 2, cisplatin IV over 30-60 minutes weekly on day 1, and radiation therapy once daily, 5 days a week.

7 weeks

Weekly visits for drug administration and daily visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes imaging and assessment of metabolic response.

2 years

Every 2 weeks for 3 months, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Berzosertib (M6620)
• Cisplatin
• Radiation Therapy

Trial Overview The trial is testing Berzosertib combined with usual chemotherapy (Cisplatin) and radiation therapy in patients with advanced head and neck cancer. It aims to find the best dose of Berzosertib that's effective but also safe when used alongside standard treatments.

How Is the Trial Designed?

Group I: Treatment (berzosertib, cisplatin, radiation therapy) Experimental Treatment 7 Interventions

Patients receive berzosertib IV over 60 minutes on day -7 and then weekly on day 2 and cisplatin IV over 30-60 minutes weekly on day 1. Patients also undergo radiation therapy once daily, 5 days a week. Treatment continues for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT, PET/CT, or MRI throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+