Berzosertib + Chemotherapy + Radiation for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen byTaofeek K Owonikoko

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

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.

Research Team

Taofeek K Owonikoko

Principal Investigator

JHU Sidney Kimmel Comprehensive Cancer Center LAO

Eligibility Criteria

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

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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.

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Treatment Details

Interventions

Berzosertib (M6620) (ATR Kinase Inhibitor)
Cisplatin (Alkylating agents)
Radiation Therapy (Radiation)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (berzosertib, cisplatin, radiation therapy)Experimental Treatment7 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.