Back to resultsPhase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
Primary Purpose
Head and Neck Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Xevinapant
Cisplatin
intensity-modulated radiation therapy (IMRT)
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Unresected, Combination with CRT, Stage III, Stage IVA, Stage IVB, Oropharynx, Hypopharynx, Larynx
Eligibility Criteria
Inclusion Criteria: Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1 Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer [AJCC]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1. Adequate hematological, hepatic, and renal function as defined in the protocol Other protocol defined inclusion criteria could apply 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 Edition) Existing need of a hearing aid or greater than or equal to (>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption Other protocol defined exclusion criteria could apply
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xevinapant + Cisplatin + IMRT
Arm Description
Participants will receive first 3 cycles of xevinapant once daily in combination therapy with weekly cisplatin and radiotherapy and 3 cycle of monotherapy of xevinapant from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks).
Outcomes
Primary Outcome Measures
Number of Participants with Dose limiting toxicity (DLT)-like events
Secondary Outcome Measures
Number of Participants with Adverse Events (AEs) and Treatment-Related AEs (TRAE)
Absolute changes in estimated glomerular filtration rate (eGFR)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 criteria as assessed by Investigator
Progression Free Survival (PFS) According to RECIST version 1.1 Criteria as Assessed by Investigator
Locoregional Control (LRC) According to RECIST version 1.1 Criteria As assessed by Investigator
LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes.
Time to Subsequent Systemic Cancer Treatments
Full Information
NCT ID
NCT06056310
First Posted
September 20, 2023
Last Updated
September 20, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT06056310
Brief Title
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
Official Title
A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 16, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Unresected, Combination with CRT, Stage III, Stage IVA, Stage IVB, Oropharynx, Hypopharynx, Larynx
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xevinapant + Cisplatin + IMRT
Arm Type
Experimental
Arm Description
Participants will receive first 3 cycles of xevinapant once daily in combination therapy with weekly cisplatin and radiotherapy and 3 cycle of monotherapy of xevinapant from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks).
Intervention Type
Drug
Intervention Name(s)
Xevinapant
Other Intervention Name(s)
Debio 1143
Intervention Description
Participants will receive first 3 cycles of xevinapant once daily in combination therapy with weekly cisplatin and radiotherapy and 3 cycle of monotherapy of xevinapant from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks).
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Participants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2).
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy (IMRT)
Intervention Description
Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week
Primary Outcome Measure Information:
Title
Number of Participants with Dose limiting toxicity (DLT)-like events
Time Frame
From Day 1 up to 5 Weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) and Treatment-Related AEs (TRAE)
Time Frame
From Day 1 up to 18 weeks (Each cycle is of 3 Weeks)
Title
Absolute changes in estimated glomerular filtration rate (eGFR)
Time Frame
From Screening up to Cycle 3 Day 4 (Day 67)
Title
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 criteria as assessed by Investigator
Time Frame
Time from first administration of study intervention until Progressive Disease (PD) or death, whichever is earlier assessed approximately up to 1.6 years
Title
Progression Free Survival (PFS) According to RECIST version 1.1 Criteria as Assessed by Investigator
Time Frame
Time from first administration of study intervention until PD or death, whichever is earlier assessed approximately up to 1.6 years
Title
Locoregional Control (LRC) According to RECIST version 1.1 Criteria As assessed by Investigator
Description
LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes.
Time Frame
From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or End of Study assessed approximately up to 1.6 years
Title
Time to Subsequent Systemic Cancer Treatments
Time Frame
From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or End of Study, assessed approximately up to 1.6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1
Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer [AJCC]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx
Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured
Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1.
Adequate hematological, hepatic, and renal function as defined in the protocol
Other protocol defined inclusion criteria could apply
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 Edition)
Existing need of a hearing aid or greater than or equal to (>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded
Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption
Other protocol defined exclusion criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Medical Information
Phone
888-275-7376
Email
eMediUSA@emdserono.com
First Name & Middle Initial & Last Name or Official Title & Degree
Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono Research & Development Institute, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Billerica
State/Province
Massachusetts
ZIP/Postal Code
01821
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Please Contact U.S. Medical Information
Phone
888-275-7376
Email
eMediUSA@emdserono.com
Facility Name
Research Site
City
Darmstadt
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Please Contact the Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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 the 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
Links:
URL
https://clinicaltrials.emdgroup.com/en
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources
Learn more about this trial
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
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