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

NCT06110195 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-31

No results posted yet for this study

Summary

The goal of this clinical trial is to determine the best safe dose of xevinapant that can be given in combination with chemotherapy and radiation in patients with head and neck cancer. Up to 4 doses of xevinapant will be tested in the dose escalation portion of the study. After the best safe dose is found during escalation, an additional group of participants will be enrolled at that dose to learn more about the treatment combination (dose expansion).

The main question\[s\] it aims to answer are:

* what is the maximum safe dose that can be given
* what dose should be used in subsequent (phase 2) trials

Participants will receive xevinapant in combination with paclitaxel and carboplatin chemotherapy and radiation. Treatment will be given in 3-week cycles for 3 cycles.

Conditions

Interventions

DRUG

Xevinapant

Given orally during study treatment on days 1-14 of a 21-day treatment cycles. It will be given continuously during treatment with carboplatin, paclitaxel, and radiation (chemoRT). After completely of the chemoRT dosing, an additional 3 cycles of Xevinapant along will be given.

DRUG

Carboplatin

Given with radiation weekly for 7 doses.

DRUG

Paclitaxel

Given with radiation weekly for 7 doses.

RADIATION

Radiation Therapy

Radiation will be given together with paclitaxel and carboplatin for 7 weeks.

Sponsors & Collaborators

  • EMD Serono

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Ari Rosenberg, ND · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2025-05-12
Completion
2025-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110195 on ClinicalTrials.gov