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A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (TrilynX)

Suzuki Tomoya

Merck Biopharma Co., Ltd.

1-8-1 Shimomeguro, Meguro-ku, Tokyo

MBJ_clinicaltrial_information@merckgroup.com

Clinical Trial Information for Contact

Merck Biopharma Co., Ltd.

1-8-1 Shimomeguro, Meguro-ku, Tokyo

+81-3-6756-0800

MBJ_clinicaltrial_information@merckgroup.com

Not Recruiting

Dec. 15, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
- Histologically confirmed diagnosis in previously untreated LA-SCCHN patient (stage III, IVA or IVB according to the American Joint Committee on Cancer [AJCC]/TNM Staging System, 8th Edition.) suitable for definitive CRT, of at least one of the following sites: oropharynx, hypopharynx, and larynx.
- For OroPharyngeal Cancer (OPC) patients, primary tumors must be HPV-negative as determined by p16 expression using immunohistochemistry.
- Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on Response evaluation sriteria in solid tumors (RECIST ) version 1.1.
- Peripheral neuropathy less than or equal to (<=) grade 2.
- Adequate hematologic, renal, and hepatic function.
- Other protocol defined inclusion criteria may apply.

- 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 Ed.).
- Prior definitive or adjuvant RT and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents.
- Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0 g/dL. No albumin transfusions are allowed within 2 weeks before randomization.
- Known allergy to Debio 1143, cisplatin, carboplatin, other platinum-based agent or any excipient known to be present in any of these products or in the placebo formulation.
- other protocol defined exclusion criteria may apply.

Both

Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Experimental arm:
Concomitant chemo-radiation therapy period (Cycles 1-3):
- Debio1143 (Xevinapant): Debio1143 administrated as oral solution from Day 1 to 14, every 21-day cycle.
- Cisplatin: Cisplatin administered as an IV infusion every 3 weeks (Q3W).
- Intensity Modulation Radiation Therapy (IMRT): 70 Gy given in 35 fractions over 7 weeks.
Monotherapy period (Cycles 4-6):
- Debio1143 (Xevinapant): Debio1143 administrated as oral solution from Day 1 to 14, every 21-day cycle.

Active comparator arm:
Concomitant chemo-radiation therapy period (Cycles 1-3):
- Placebo: Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.
- Cisplatin: Cisplatin administered as an IV infusion every 3 weeks (Q3W).
- Intensity Modulation Radiation Therapy (IMRT): 70 Gy given in 35 fractions over 7 weeks.
Monotherapy period (Cycles 4-6):
- Placebo: Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.

Event-Free Survival (EFS) [Time Frame: Up to 5 years ]
EFS is the time from the date of randomization to the date of first record of disease progression or death.

+81-429844523

Nov. 24, 2021

No

Argentina/Australia/Austria/Belgium/Brazil/Canada/China/Czech Republic/France/Georgia/Germany/Greece/Hungary/Israel/Italy/Poland/Portugal/Russia/Republic of Korea/Spain/Switzerland/Taiwan/Ukraine/UK/USA