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Alkylating agents

Xevinapant + Chemoradiation for Head and Neck Cancer

Phase 1

Waitlist Available

Led By Ari Rosenberg, ND

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Adequate renal function was defined as follows: Creatinine clearance (CrCl) > 30 mL/min

Age >= 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will test a new drug (xevinapant) combined with chemotherapy and radiation to fight head and neck cancer. Participants will get up to 4 doses to determine the safest dose, then a larger group will try that dose.

Who is the study for?

This trial is for adults with certain types of head and neck squamous cell carcinoma who cannot use cisplatin. They must have a specific stage of cancer, measurable disease, good organ function, and agree to contraception. Excluded are those with distant metastasis, prior chemo or radiotherapy for the same cancer within 3 years, severe health issues like recent heart attacks or active infections, pregnant women, and those on certain medications.Check my eligibility

What is being tested?

The study tests different doses of Xevinapant combined with chemotherapy (Paclitaxel and Carboplatin) and radiation therapy in patients with head and neck cancer. It aims to find the maximum safe dose for future phase 2 trials. Participants will undergo treatment cycles lasting three weeks each for a total of three cycles.See study design

What are the potential side effects?

Potential side effects include reactions related to chemotherapy such as nausea, fatigue, hair loss; radiation therapy may cause skin irritation or difficulty swallowing; Xevinapant's side effects aren't fully known but could involve similar symptoms due to its nature as an anti-cancer agent.

Eligibility Criteria

Inclusion Criteria

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

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My kidneys are working well enough (CrCl > 30 mL/min).

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I am 18 years old or older.

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My sinus cancer is advanced but hasn't spread far and can't be removed with surgery.

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I have at least one tumor that can be measured by medical imaging.

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I can take care of myself and perform daily activities.

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I have been diagnosed with a specific type of throat or mouth cancer.

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My throat cancer is P16 positive and falls within specific stages.

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I cannot take cisplatin due to health reasons.

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My cancer is in the early to mid stages and located in my mouth, throat, or voice box.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Determine best safe dose of xevinapant when given in combination with radiation and chemotherapy

Secondary outcome measures

Distant Failure

Locoregional failure

Number of side effects seen when xevinapant is given in combination with radiation and chemotherapy

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Escalation Group Dose Level 2Experimental Treatment4 Interventions

Participants assigned to this cohort will receive xevinapant 200 mg for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT). An additional 3 cycles of xevinapant will be given after completion of chemoRT.

Group II: Escalation Group Dose Level 1Experimental Treatment4 Interventions

Participants assigned to this cohort will receive xevinapant 150 mg for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT). An additional 3 cycles of xevinapant will be given after completion of chemoRT.

Group III: Escalation Group Dose Level 0Experimental Treatment4 Interventions

Participants assigned to this cohort will receive xevinapant 100 mg for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT). An additional 3 cycles of xevinapant will be given after completion of chemoRT.

Group IV: Escalation Group Dose Level -1Experimental Treatment4 Interventions

Participants assigned to this cohort will receive xevinapant 50 mg for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT). An additional 3 cycles of xevinapant will be given after completion of chemoRT.

Group V: Dose ExpansionExperimental Treatment4 Interventions

Participants assigned to this cohort will receive xevinapant at the dose found during escalation phase of study for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT). An additional 3 cycles of xevinapant will be given after completion of chemoRT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

EMD SeronoIndustry Sponsor

143 Previous Clinical Trials

27,159 Total Patients Enrolled

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,707 Total Patients Enrolled

Ari Rosenberg, NDPrincipal InvestigatorUniversity of Chicago

Frequently Asked Questions

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

Has the FDA sanctioned Escalation Group Dose Level -1?

"Due to a lack of evidence, Escalation Group Dose Level -1 was assigned with score 1 on our safety scale from Power. This is typical for phase 1 trials, which are based on limited data regarding efficacy and security."

Answered by AI

Is this investigation currently recruiting participants?

"Unfortunately, the data on clinicaltrials.gov suggests that this particular study is not actively enrolling patients at present. Originally posted in December of 2023 and last updated by October 25th of the same year, there are presently 3123 other trials seeking participants around the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Xevinapant With Radiation and Chemotherapy for Patients With Head and Neck Cancer

2024. "Study of Xevinapant With Radiation and Chemotherapy for Patients With Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110195.

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