Trial · NCT04459715
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)
NCT04459715, Phase 3, Terminated, EMD Serono Research & Development Institute, Inc.; results first posted 2025-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT04459715. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04459715
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT04459715
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 730 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Xevinapant (Debio 1143), Cisplatin, Intensity Modulation Radiation Therapy (IMRT), Placebo
- First posted
- 2020-07-07
- Last updated
- 2025-10-08
- Other registries' IDs
- eudract:2020-000377-25
- Results first posted
- 2025-10-08
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) as Assessed by Blinded Independent Review Committee (BIRC) | From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days) | Event-Free Survival (EFS) as assessed by BIRC is the time from randomization to the first of: (1) Death from any cause; (2) Progression: either radiological (per RECIST v1.1) or clinical (with/without radiologic proof, assessed endoscopically); (3) Primary treatment failure prior to complete response (CR): requirement for radical salvage surgery at primary tumor site with viable tumor confirmed histologically, even without RECIST progression; (4) Relapse after CR (locoregional): including radical salvage surgery or elective neck dissection/biopsy more than equal to (\>=) 22 weeks post-randomization showing viable tumor cells regardless of radiologic status; (5) Second cancers, unless histology excludes squamous origin. Calculated via Kaplan Meier method. |
| Secondary | Overall Survival (OS) | From randomization to the earliest between death or EOS (up to 188 weeks and 5 days) | Overall survival is defined as the time from randomization to the date of death. Calculated via Kaplan Meier method. |
| Secondary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Review Committee (BIRC) | From randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause or EOS (up to 188 weeks and 5 days ) | PFS according to RECIST v1.1 defined as the time from randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 millimeter (mm) in the SOD, or the appearance of new lesions. Calculated via Kaplan Meier method. |
| Secondary | Locoregional Control (LRC) Time | From randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End Of Study (EOS) (188 weeks and 5 days) | LRC time is defined as the time from randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes, either according to RECIST v1.1 or based on clinical assessment (radiological or clinical, as assessed by the Investigator). According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 millimeter (mm) in the SOD, or the appearance of new lesions. Calculated via Kaplan Meier method. |
| Secondary | Objective Response Rate (ORR) as Assessed by BIRC | At 9 and 12 months post randomization | Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, or unequivocal progression of non-target lesions, or appearance of any new lesion. |
| Secondary | Complete Response Rate (CRR) | At 9 and 12 months post randomization | CRR defined as the number of participants with Complete Response by RECIST v1.1, as assessed by the BIRC. Complete response is defined as disappearance of all target and non-target lesions. |
| Secondary | Duration of Response (DOR) | Time from first evidence of response to the first occurrence of progression or death from any cause, assessed up to 24 months | 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. Kaplan Meier method was used for calculation. |
| Secondary | Number of Participants With Radical Salvage Surgery | At 9, 12, 24 and 36 months post randomization | Number of Participants with Radical Salvage Surgery (excluding elective neck dissection without anatomopathological evidence of residual malignant cells) was reported. |
| Secondary | Time to Subsequent Systemic Cancer Treatments | Up to 188 weeks and 5 days post randomization | Time to new subsequent systemic cancer treatment (in months) was derived as (date of event/censoring - randomization date +1) / 30.4375. Calculated via kaplan meier method. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events (AEs) of Special Interest | From signed informed consent to EOS (up to 188 weeks and 5 days) | An AE is any unfavorable/unintended sign (e.g., abnormal lab result), symptom or disease temporally linked to study drug, whether or not related. A serious AE leads to death, is life-threatening, causes significant/persistent disability, hospitalization, congenital anomaly, or is medically important. TEAEs include both serious and non-serious AEs after treatment. AESIs are events of clinical interest needing close monitoring. In this study, AESIs include: infusion reactions including hypersensitivity, immune-related AEs, aspartate aminotransferase/alanine transaminase increases, lipase/amylase elevation, acute renal failure, QTcF more than 30 milliseconds above baseline, and ≥Grade 2 inflammatory cutaneous AEs. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Survival (OS) | From randomization to the earliest between death or EOS (up to 188 weeks and 5 days) | The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Review Committee (BIRC) | From randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause or EOS (up to 188 weeks and 5 days ) | The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. | months | MEDIAN |
| SECONDARY | Locoregional Control (LRC) Time | From randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End Of Study (EOS) (188 weeks and 5 days) | The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) as Assessed by BIRC | At 9 and 12 months post randomization | The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate (CRR) | At 9 and 12 months post randomization | The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Time from first evidence of response to the first occurrence of progression or death from any cause, assessed up to 24 months | The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. Number of participants analyzed signifies participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Number of Participants With Radical Salvage Surgery | At 9, 12, 24 and 36 months post randomization | The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Subsequent Systemic Cancer Treatments | Up to 188 weeks and 5 days post randomization | The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events (AEs) of Special Interest | From signed informed consent to EOS (up to 188 weeks and 5 days) | The safety analysis set (SAF set) included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Severity of Grade Greater or Equal to 3 TEAEs | From signed informed consent to EOS (up to 188 weeks and 5 days) | The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group428
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Sequence 1: Debio 1143 + CRT | NA | Full Range 0.0 to 37.6 | months | |
| Overall Survival (OS) | Sequence 2: Placebo + CRT | NA | Full Range 0.0 to 39.4 | months | |
| Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Review Committee (BIRC) | Sequence 1: Debio 1143 + CRT | 26.8 | 95% Confidence Interval 15.93 to NA | months | |
| Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Review Committee (BIRC) | Sequence 2: Placebo + CRT | 33.1 | 95% Confidence Interval 22.83 to NA | months | |
| Locoregional Control (LRC) Time | Sequence 1: Debio 1143 + CRT | NA | Full Range 0.0 to 37.0 | months | |
| Locoregional Control (LRC) Time | Sequence 2: Placebo + CRT | NA | Full Range 0.0 to 38.2 | months | |
| Objective Response Rate (ORR) as Assessed by BIRC | Sequence 1: Debio 1143 + CRT | 9 Months Post Randomization | 73.4 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed by BIRC | Sequence 2: Placebo + CRT | 9 Months Post Randomization | 77.3 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed by BIRC | Sequence 1: Debio 1143 + CRT | 12 Months Post Randomization | 73.6 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed by BIRC | Sequence 2: Placebo + CRT | 12 Months Post Randomization | 77.9 | percentage of participants |
1 to 10 of 428Source ClinicalTrials.gov
See all 428 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1: Debio 1143 + CRT | 364 | |
| Overall Study | STARTED | Sequence 2: Placebo + CRT | 366 | |
| Overall Study | COMPLETED | Sequence 1: Debio 1143 + CRT | 0 | |
| Overall Study | COMPLETED | Sequence 2: Placebo + CRT | 0 | |
| Overall Study | NOT COMPLETED | Sequence 1: Debio 1143 + CRT | 364 | |
| Overall Study | NOT COMPLETED | Sequence 2: Placebo + CRT | 366 |
Source ClinicalTrials.gov
Adverse events508
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sequence 1: Debio 1143 + CRT | 180 | 364 | 212 |
| other | Anaemia | Blood and lymphatic system disorders | Sequence 2: Placebo + CRT | 199 | 356 | 244 |
| other | Leukopenia | Blood and lymphatic system disorders | Sequence 1: Debio 1143 + CRT | 44 | 364 | 69 |
| other | Leukopenia | Blood and lymphatic system disorders | Sequence 2: Placebo + CRT | 57 | 356 | 79 |
| other | Lymphopenia | Blood and lymphatic system disorders | Sequence 1: Debio 1143 + CRT | 42 | 364 | 46 |
| other | Lymphopenia | Blood and lymphatic system disorders | Sequence 2: Placebo + CRT | 39 | 356 | 48 |
| other | Neutropenia | Blood and lymphatic system disorders | Sequence 1: Debio 1143 + CRT | 100 | 364 | 136 |
| other | Neutropenia | Blood and lymphatic system disorders | Sequence 2: Placebo + CRT | 110 | 356 | 141 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sequence 1: Debio 1143 + CRT | 45 | 364 | 61 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sequence 2: Placebo + CRT | 63 | 356 | 79 |
1 to 10 of 508Source ClinicalTrials.gov
See all 508 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sequence 1: Debio 1143 + CRT | 111 | 364 |
| Total, all-cause mortality | Sequence 2: Placebo + CRT | 93 | 366 |
| Total, other adverse events | Sequence 1: Debio 1143 + CRT | 360 | 364 |
| Total, other adverse events | Sequence 2: Placebo + CRT | 350 | 356 |
| Total, serious adverse events | Sequence 1: Debio 1143 + CRT | 194 | 364 |
| Total, serious adverse events | Sequence 2: Placebo + CRT | 129 | 356 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sequence 1: Debio 1143 + CRT vs Sequence 2: Placebo + CRT: deaths from any cause | Trial comparisons |
| Sequence 1: Debio 1143 + CRT vs Sequence 2: Placebo + CRT: Number of Participants With Severity of Grade Greater or Equal to 3 TEAEs | Trial comparisons |
| Sequence 1: Debio 1143 + CRT vs Sequence 2: Placebo + CRT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04459715
GET https://conductscience.org/api/trials/v1/NCT04459715/registered?page=2