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A Study of 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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459715
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
GORTEC (Head and Neck Oncology and Radiotherapy Group)
Information provided by (Responsible Party):
Debiopharm International SA

Brief Summary:
The primary objective of the study is to demonstrate superior efficacy of 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
Carcinoma, Squamous Cell of the Head and Neck Drug: Debio 1143 Drug: Cisplatin Radiation: Intensity Modulation Radiation Therapy (IMRT) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 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


Arm Intervention/treatment
Experimental: Debio 1143

Participants will receive:

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

  • Radiotherapy
  • Cisplatin
  • Debio 1143

Monotherapy period (Cycles 4-6):

• Debio 1143

Drug: Debio 1143
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.




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. 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)

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

  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. 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) ]
  5. 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)

  6. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 in 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 Ed.) 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 RECIST v 1.1
  • Peripheral neuropathy < grade 2
  • Adequate hematologic, renal and hepatic function

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 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
  • Known allergy to Debio 1143, cisplatin or any excipient known to be present in Debio1143 or in the placebo formulation.

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


Contacts
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Contact: Debiopharm International S.A +41 21 321 01 11 clinicaltrials@debiopharm.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Debiopharm International SA
GORTEC (Head and Neck Oncology and Radiotherapy Group)
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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT04459715    
Other Study ID Numbers: Debio 1143-SCCHN-301
2020-000377-25 ( EudraCT Number )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
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