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Trial record 1 of 1 for:    MS202359_0006 / Debio 1143-SCCHN-301
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A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459715
Recruitment Status : Active, not recruiting
First Posted : July 7, 2020
Last Update Posted : April 6, 2023
Sponsor:
Collaborators:
GORTEC (Head and Neck Oncology and Radiotherapy Group)
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Description
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Brief Summary:
The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Xevinapant (Debio 1143) Drug: Cisplatin Radiation: Intensity Modulation Radiation Therapy (IMRT) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 730 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : April 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Xevinapant (Debio 1143)

Participants will receive:

Concomitant chemo-radiation therapy period (Cycles 1-3):

  • Radiotherapy
  • Cisplatin
  • Xevinapant (Debio 1143)

Monotherapy period (Cycles 4-6):

• Xevinapant (Debio 1143)

 Drug: Xevinapant (Debio 1143)
Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.

Drug: Cisplatin
Cisplatin administered as an IV infusion every 3 weeks (Q3W).

Radiation: Intensity Modulation Radiation Therapy (IMRT)
70 Gy given in 35 fractions over 7 weeks.
Active Comparator: Placebo

Participants will receive:

Concomitant chemo-radiation therapy period (Cycles 1-3):

  • Radiotherapy
  • Cisplatin
  • Matched placebo

Monotherapy period (Cycles 4-6):

• Matched placebo

 Drug: Cisplatin
Cisplatin administered as an IV infusion every 3 weeks (Q3W).

Radiation: Intensity Modulation Radiation Therapy (IMRT)
70 Gy given in 35 fractions over 7 weeks.

Drug: Placebo
Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 5 years ]
    OS is the time from randomization to death due to any cause.

  2. Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]
    PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)

  3. Locoregional Control (LRC) [ Time Frame: From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years) ]
  4. Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]
    ORR defined as proportion of participants with complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by Blinded Independent Review Committee (BIRC).

  5. Complete Response Rate (CRR) [ Time Frame: Up to 5 years ]
    CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).

  6. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause.

  7. Number of Participants with Radical Salvage Surgery [ Time Frame: Up to 5 years ]
  8. Time to Subsequent Systemic Cancer Treatments [ Time Frame: Up to 5 years ]
  9. Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure [ Time Frame: From signed informed consent to EOS (within 6.8 years) ]
  10. Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom [ Time Frame: Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years) ]
    Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)

  11. Changes from Baseline in Swallowing and Pain Symptoms [ Time Frame: Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years) ]
    Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
  • Histologically confirmed diagnosis of previously untreated Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb according to the American Joint Committee on Cancer(AJCC))/Classification of malignant tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant metastasis (TNM) Staging System, 8th Edition.) suitable for definitive ChemoRadiotherapy (CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx
  • For OroPharyngeal Cancer (OPC) participants, primary tumors must be human papillomavirus (HPV)-negative as determined by p16 expression using immunohistochemistry
  • Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on Response evaluation criteria in solid tumors (RECIST) version 1.1
  • Peripheral neuropathy less than (<) grade 2
  • Adequate hematologic, renal and hepatic function
  • Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  • Primary tumor of nasopharynx, 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 Radiotherapy (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 Xevinapant (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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459715


Locations
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Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
GORTEC (Head and Neck Oncology and Radiotherapy Group)
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT04459715    
Other Study ID Numbers: MS202359_0006
2020-000377-25 ( EudraCT Number )
Debio 1143-SCCHN-301 ( Other Identifier: Previous Sponsor Identifier )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Access Criteria: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
URL: http://bit.ly/IPD21

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
TrilynX
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cisplatin
Antineoplastic Agents