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Alkylating agents

Xevinapant + Chemoradiotherapy for Head and Neck Cancer

Phase 1

Recruiting

Research Sponsored by EMD Serono Research & Development Institute, Inc.

Eligibility Criteria Checklist

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

Must have

Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer [AJCC]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx

Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from first administration of study intervention until pd or death, whichever is earlier assessed approximately up to 1.6 years

Awards & highlights

Study Summary

This trial evaluates a drug to treat head and neck cancer with chemoradiotherapy, to see if it's safe and tolerable.

Who is the study for?

This trial is for adults with a specific type of throat cancer called LA SCCHN that hasn't spread elsewhere and can't be removed by surgery. They should be fairly active (ECOG PS 0-1), able to swallow or receive liquid nutrition, have functioning major organs, and no severe hearing loss. People with HIV, recent major gut surgery, or malabsorption issues cannot join.Check my eligibility

What is being tested?

The study tests the safety of Xevinapant combined with weekly Cisplatin chemotherapy and IMRT radiation therapy in treating unresectable locally advanced head and neck cancers. It aims to see how well patients tolerate this combination treatment.See study design

What are the potential side effects?

Possible side effects include reactions related to Xevinapant such as fatigue, nausea, skin rash; Cisplatin may cause kidney problems, hearing damage, nerve issues; IMRT might lead to skin irritation at the treated site.

Eligibility Criteria

Inclusion Criteria

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

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I have a specific type of throat cancer that has not been treated yet.

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I can swallow liquids or have a working feeding tube.

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I can carry out all my daily activities without any problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from first administration of study intervention until pd or death, whichever is earlier assessed approximately up to 1.6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from first administration of study intervention until pd or death, whichever is earlier assessed approximately up to 1.6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first administration of study intervention until pd or death, whichever is earlier assessed approximately up to 1.6 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

Number of Participants with Dose limiting toxicity (DLT)-like events

Secondary outcome measures

Absolute values and changes in estimated glomerular filtration rate (eGFR)

Locoregional Control (LRC) According to RECIST version 1.1 Criteria As assessed by Investigator

Number of Participants with Adverse Events (AEs) and Treatment-Related AEs (TRAE)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Xevinapant + Cisplatin + IMRTExperimental Treatment3 Interventions

Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

intensity-modulated radiation therapy (IMRT)

2010

Completed Phase 2

~90

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor

76 Previous Clinical Trials

30,820 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,616 Total Patients Enrolled

Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.

288 Previous Clinical Trials

68,935 Total Patients Enrolled

Frequently Asked Questions

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

To what extent is Xevinapant + Cisplatin + IMRT a secure treatment option for patients?

"Our team at Power gave Xevinapant + Cisplatin + IMRT a score of 1, as the limited clinical data available suggests that this treatment has not been proven safe or effective yet."

Answered by AI

Has this investigation opened its doors to new participants?

"According to clinicaltrials.gov, this medical research is not currently enlisting participants. The trial was first revealed on October 2nd 2023 and the last edit took place on September 20th 20203. At present there are 497 active trials looking for volunteers; however, this specific experiment is not one of them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)

2024. "Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06056310.

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