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

JRCT ID: jRCT2031210525

Registered date:28/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Locally Advanced Squamous Cell Carcinoma of the Head and Neck
• Date of first enrollment: 15/12/2021
• Target sample size: 700
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,France,Japan,Georgia,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Poland,Japan,Portugal,Japan,Russia,Japan,Republic of Korea,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,Ukraine,Japan,UK,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

Primary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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.

Exclude 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 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.

Related Information

• Primary Sponsor: Suzuki Tomoya