Tolinapant and Radiation Therapy for the Treatment of Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer

Active:	Yes
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT05245682
Trial Phases:	Phase I	Protocol IDs:	WINSHIP5380-21 (primary) NCI-2021-09678 STUDY00002992
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05245682

Summary

This phase I trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past (previously untreated), has spread to nearby tissue or lymph nodes (locally advanced) and cannot receive cisplatin (cisplatin-ineligible). Tolinapant may stop the growth of cancer cells by blocking XIAP and cIAP1, proteins needed for cancer cell survival. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tolinapant and radiation therapy may kill more tumor cells.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of tolinapant in combination with radiation in patients with head and neck squamous cell carcinoma (HNSCC).

SECONDARY OBJECTIVE:
I. To evaluate the anti-tumor activity of the combination of tolinapant + radiation by assessing locoregional control (LRC) and overall survival (OS).

TERTIARY/EXPLORATORY OBJECTIVES:
I. To assess the effects of the combination of tolinapant + radiation on immune cells in blood and tumor.
II. To assess the association between immune responses and FADD expression in tumors.

OUTLINE:
Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant orally (PO) daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET) during screening and follow-up. Additionally, patients undergo blood sample collection and tissue biopsy during screening on the trial.

After completion of study treatment, patients are followed up 1, 3, 6, 12, and 24 months.

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