A single-arm, open-label, Phase Ib study of xevinapant in combination with weekly cisplatin and intensity-modulated radiotherapy to assess safety and tolerability in participants with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

To evaluate tolerability of xevinapant when added to weekly cisplatin-based CRT in LA SCCHN

Secondary Objectives:

To characterize safety of xevinapant when added to weekly cisplatin-based CRT in LA SCCHN
To evaluate clinical activity parameters using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
To evaluate time to subsequent cancer treatments in participants treated with xevinapant when added to weekly cisplatin-based CRT in LA SCCHN

Eligibility

Inclusion Criteria:

Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1
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
Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1.
Adequate hematological, hepatic, and renal function as defined in the protocol
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Primary tumor of nasopharyngeal, paranasal sinuses, nasal, or oral cavity, salivary, thyroid, or parathyroid gland pathologies, skin, or unknown primary site
Metastatic disease (Stage IVC as per AJCC/TNM, 8th Edition)
Existing need of a hearing aid or greater than or equal to (>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded
Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption
Other protocol defined exclusion criteria could apply

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices