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Study of Xevinapant With Radiation and Chemotherapy for Patients With Head and Neck Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

A Phase I Study of Xevinapant With Radiation and Concurrent Carboplatin and Paclitaxel in Patients Ineligible for Cisplatin With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT06110195•University of Chicago

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Pathologically proven diagnosis of squamous cell carcinoma of the head and neck (HNSCC) of the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, or sinuses.
•* Patients with oropharynx cancer need p16 determination by immunohistochemistry (where positive is defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells).
•* Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be stages T1-2N1-3 or T3-4N0-3 (AJCC 8th edition). Sinus primary must be T4bN0-3 not amenable to surgical resection.
•* P16-positive oropharynx cancer patients, stages T1-2N1-3 or T3-4N0-3 (AJCC 8th edition staging).
•2. The patient has unresected, measurable disease as defined by the presence of at least one measurable lesion per RECIST 1.1.
•3. Age \>= 18 years of age
•4. Patients must have a contraindication to cisplatin
•5. Performance Status of 0-2
•6. Adequate hematologic function
•* White Blood Cell Count (WBC) \>= 2000 cells/mm3
+11 more criteria

Exclusion Criteria

•1. Definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease.
•2. Carcinoma of the neck of unknown primary site of origin
•3. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if not within \< 3 years
•4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
•5. Severe, active co-morbidity defined as follows:
•* History of bone marrow transplant and organ transplant, including allogeneic stem cell transplantation.
•* Unstable angina requiring hospitalization in the last 6 months.
•* New York Heart Association Functional Classification III/IV.
•* Myocardial infarction within the last 6 months.
•* Persistent Grade 3-4 electrolyte abnormalities that cannot be reversed despite as indicated by repeat testing.
+7 more criteria

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Key Dates

Start Date

January 24, 2024

Primary Completion Date

October 1, 2027

Completion Date

October 1, 2027

Last Updated

June 8, 2025

Enrollment

ESTIMATED participants

Conditions

Head and Neck CancerHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Xevinapant

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Radiation Therapy

RADIATION

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

NCT06385080

Squamous Cell Carcinoma of Head and Neck

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RECRUITINGPHASE1/PHASE2

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Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

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