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Xevinapant + Cisplatin and Radiation for Head and Neck Cancer

Phase 2

Recruiting

Led By Yao Yu, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Squamous cell carcinoma of the head and neck (excluding lip) from eligible primary tumor sites including the maxillary sinus, oral cavity, HPV-negative oropharynx, larynx, and hypopharynx

Age ≥ 18 on the day of signing of the consent form

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial tests if adding Xevinapant to standard cancer treatment helps people with high-risk head & neck cancer.

Who is the study for?

Adults over 18 with high-risk head and neck cancers, who've had surgery, can swallow or have a feeding tube. They should be in good physical condition (ECOG 0-1), not pregnant or breastfeeding, willing to use contraception, and have no early cancer recurrence. Excluded are those with positive margins that can't be re-operated on.Check my eligibility

What is being tested?

The trial is testing if adding Xevinapant to the usual chemoradiation therapy after surgery helps people with high-risk head and neck cancers more than the standard treatment alone.See study design

What are the potential side effects?

Possible side effects include typical reactions from chemotherapy like nausea, fatigue, hair loss; radiation therapy may cause skin irritation or difficulty swallowing; specific side effects of Xevinapant are not listed but could resemble other cancer drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of squamous cell carcinoma in the head or neck, but not the lip.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I can swallow liquids or have a working feeding tube.

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I had surgery to remove all visible cancer within the last 10 weeks and am ready to start treatment within 6 weeks of surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival

Secondary outcome measures

Overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Xevinapant in Combination with Post-Operative Cisplatin and RadiotherapyExperimental Treatment3 Interventions

The study will consist of three phases: 2) concurrent radiation, cisplatin, and xevinapant, and 3) adjuvant xevinapant. Concurrent Chemoradiation Subjects will undergo FDG PET/CT simulation and standard radiation treatment planning. FDG PET/CT (Simulation or diagnostic) will also be utilized to rule out distant metastases. Subjects who meet criteria for the treatment phase will undergo standard of care adjuvant radiation (60-70 Gy administered in 2 Gy fractions) with concurrent cisplatin (2-3 cycles, with 100mg/m2 per cycle q3 weeks), and xevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3 cycles) Adjuvant Phase After completion of concurrent chemoradiation, patients will undergo an additional 3 cycles of xevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3- cycles)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,844 Total Patients Enrolled

Yao Yu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a plethora of clinical sites conducting this investigation in North America?

"This trial is currently running in 7 medical centres, including Memorial Sloan Kettering Monmouth (Middletown), Memorial Sloan Kettering Bergen (Montvale) and Memorial Sloan Kettering Suffolk - Commack. Additionally, there are 4 other sites participating in the study."

Answered by AI

What is the total number of participants in this research project?

"Indeed, clinicaltrials.gov lists this medical experiment as actively searching for participants. Posted on November 16th 2023 and updated the next day, it requires 54 persons to be enrolled at 7 different sites."

Answered by AI

Is this research program open to new participants?

"Affirmative, the information on clinicaltrials.gov asserts that this study is presently recruiting patients. Initially posted on November 16th 2023 and last modified a day later, this trial seeks to recruit 54 people from 7 different sites."

Answered by AI

Is there any evidence that Xevinapant is a safe supplement to post-operative cisplatin and radiotherapy?

"Our team at Power assessed the safety of Xevinapant in Combination with Post-Operative Cisplatin and Radiotherapy to be a 2 because this is only on Phase 2, meaning there are some preliminary results confirming its safety but no data proving efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Xevinapant With Cisplatin and Radiation Therapy After Surgery in People With Head and Neck Cancer

2023. "A Study of Xevinapant With Cisplatin and Radiation Therapy After Surgery in People With Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145412.