Xevinapant (Debio 1143) for Squamous cell carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Squamous cell carcinoma+8 More
Xevinapant (Debio 1143) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding the drug Xevinapant to standard chemoradiotherapy treatment can improve outcomes for people with locally advanced squamous cell carcinoma of the head and neck.

Eligible Conditions
  • Squamous cell carcinoma
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: From signed informed consent to EOS (within 6.8 years)

Year 5
Locoregional Control (LRC)
Year 8
Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure
Year 5
Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom
Changes from Baseline in Swallowing and Pain Symptoms
Up to 5 years
Complete Response Rate (CRR)
Duration of Response (DOR)
Event-Free Survival (EFS)
Number of Participants with Radical Salvage Surgery
Objective Response Rate (ORR)
Overall survival (OS)
Progression-Free Survival (PFS)
Time to Subsequent Systemic Cancer Treatments

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Placebo
1 of 3
Xevinapant (Debio 1143)
1 of 3
Debio 1143
1 of 3

Active Control

Experimental Treatment

700 Total Participants · 3 Treatment Groups

Primary Treatment: Xevinapant (Debio 1143) · Has Placebo Group · Phase 3

Xevinapant (Debio 1143)Experimental Group · 3 Interventions: Xevinapant (Debio 1143), Cisplatin, Intensity Modulation Radiation Therapy (IMRT) · Intervention Types: Drug, Drug, Radiation
Debio 1143Experimental Group · 3 Interventions: Cisplatin, Intensity Modulation Radiation Therapy (IMRT), Debio 1143 · Intervention Types: Drug, Radiation, Drug
PlaceboActiveComparator Group · 3 Interventions: Cisplatin, Intensity Modulation Radiation Therapy (IMRT), Placebo · Intervention Types: Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
DEBIO-1143
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from signed informed consent to eos (within 6.8 years)

Who is running the clinical trial?

GORTEC (Head and Neck Oncology and Radiotherapy Group)UNKNOWN
Debiopharm International SALead Sponsor
43 Previous Clinical Trials
5,528 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
428 Previous Clinical Trials
112,206 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
73 Previous Clinical Trials
29,274 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
276 Previous Clinical Trials
66,396 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have measurable and/or non-measurable tumor lesions assessed by computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on Response evaluation criteria in solid tumors (RECIST) version 1.1.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.