Trial · NCT03088059
Biomarker-based Study in R/M SCCHN
NCT03088059, Phase 2, Unknown, European Organisation for Research and Treatment of Cancer - EORTC
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Biomarker-based Study in R/M SCCHN. Trials, record NCT03088059. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03088059
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biomarker-based Study in R/M SCCHN
- NCT number
- NCT03088059
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 340 participants, estimated
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Conditions
- Carcinoma, Squamous Cell of Head and Neck
- Interventions
- Afatinib, Palbociclib, standard of care, IPH2201, Durvalumab, Niraparib, INCAGN01876
- First posted
- 2017-03-23
- Last updated
- 2023-11-03
- Other registries' IDs
- eudract:2017-000086-74
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival Rate (PFSR) at week 16 | The Progression Free Survival Rate (PFSR) analysis will be performed at week 16 for each patient in cohorts 1, 2 and 3. | Progression Free Survival Rate (PFSR) at week 16 will be assessed as primary endpoint for all patients from cohorts 1, 2 and 3. |
| Primary | Objective response Rate (ORR) at week 16 | Objective response Rate (ORR) at week 16 will be performed at week 16 for each patient in cohort 4. | Objective response Rate (ORR) during the first 16 weeks of study treatment will be assessed as primary endpoint for all patients from cohort 4-8. |
| Secondary | Progression Free Survival (PFS) | 54 months after first patient in | |
| Secondary | Objective Response Rate | 48 months after first patient in | Objective Response Rate will be measured according to both RECIST 1.1 and iRECIST |
| Secondary | Response duration | 54 months after first patient in | |
| Secondary | Overall Survival (OS) | 54 months after first patient in | |
| Secondary | Toxicity according CTCAE version 4.03 | 54 months after first patient in | This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, for adverse event reporting. |
| Secondary | Percentage of patients included in each patient cohort according the biomarker testing | 42 months after first patient in | |
| Secondary | The percentage of patients with an evaluable fresh tumor biopsy | 42 months after first patient in |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30307465 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03088059
GET https://conductscience.org/api/trials/v1/NCT03088059/registered