Trial · NCT05323656
A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
NCT05323656, Phase 2, Completed, Calliditas Therapeutics Suisse SA; results first posted 2025-05-09
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN). Trials, record NCT05323656. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05323656
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
- NCT number
- NCT05323656
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Calliditas Therapeutics Suisse SA
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- Setanaxib, Pembrolizumab, Placebo
- First posted
- 2022-04-12
- Last updated
- 2025-09-02
- Results first posted
- 2025-05-09
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Percentage Change in Tumour Size | Baseline to at least 15 weeks and up to 51 weeks | Defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1. |
| Secondary | Progression Free Survival (PFS) | Baseline up to approximately 21 months | Defined as time from randomisation to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. |
| Secondary | Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue | Baseline up to approximately 9 weeks | Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups. |
| Secondary | Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue | Baseline up to approximately 9 weeks | Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups. |
| Secondary | Change From Baseline in the Number of Regulatory T-cells in Tumour Tissue | Baseline up to approximately 9 weeks | Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups. |
| Secondary | Overall Response Rate (ORR) | Baseline up to approximately 12 months | Proportion of the patients who have a complete response (CR) or partial response (PR) per RECIST v1.1 will be used to access ORR. |
| Secondary | Duration of Response (DoR) | Baseline up to approximately 12 months | The minimum time when CR or PR is first observed to the time of progression of disease (PD) or death will be used to access DoR. |
| Secondary | Disease Control Rate (DCR) | Baseline up to approximately 12 months | Proportion of the patients in whom the best overall response is determined as CR, PR, or stable disease (SD) per RECIST v1.1 will be used to access DCR. |
| Secondary | Overall Survival (OS) | Baseline up to 12 months | Defined as the time from randomisation to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up. |
| Secondary | Number of Participants With Adverse Events (AEs) | Baseline up to approximately 21 months | Any clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests (including biochemistry, hematology, urinalysis, and thyroid function), or 12- lead electrocardiogram (ECG) results will be recorded as Adverse Events (AEs). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Percentage Change in Tumour Size | Baseline to at least 15 weeks and up to 51 weeks | Full Analysis Set | Percentage change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Progression Free Survival (PFS) | Baseline up to approximately 21 months | Full Analysis Set | days | MEDIAN |
| SECONDARY | Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue | Baseline up to approximately 9 weeks | Full Analysis Set | % positivity of tumour stromal component | MEAN |
| SECONDARY | Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue | Baseline up to approximately 9 weeks | Full Analysis Set) | cells/High Power Field (HPF) | MEAN |
| SECONDARY | Change From Baseline in the Number of Regulatory T-cells in Tumour Tissue | Baseline up to approximately 9 weeks | cells/High Power Field (HPF) | MEAN | |
| SECONDARY | Overall Response Rate (ORR) | Baseline up to approximately 12 months | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) | Baseline up to approximately 12 months | Full Analysis Set | days | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Baseline up to approximately 12 months | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Baseline up to 12 months | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Baseline up to approximately 21 months | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Percentage Change in Tumour Size | Setanaxib 1600 mg and Pembrolizumab 200 mg | -7.88 | Standard Error 9.323 | Percentage change from baseline | |
| Best Percentage Change in Tumour Size | Placebo and Pembrolizumab 200 mg | -12.93 | Standard Error 8.977 | Percentage change from baseline | |
| Progression Free Survival (PFS) | Setanaxib 1600 mg and Pembrolizumab 200 mg | 151 | 80% Confidence Interval 125 to 229 | days | |
| Progression Free Survival (PFS) | Placebo and Pembrolizumab 200 mg | 87 | 80% Confidence Interval 65 to 117 | days | |
| Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue | Setanaxib 1600 mg and Pembrolizumab 200 mg | Baseline | 58.13 | Standard Deviation 37.006 | % positivity of tumour stromal component |
| Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue | Placebo and Pembrolizumab 200 mg | Baseline | 52.00 | Standard Deviation 23.357 | % positivity of tumour stromal component |
| Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue | Setanaxib 1600 mg and Pembrolizumab 200 mg | Week 9 | 50.50 | Standard Deviation 31.023 | % positivity of tumour stromal component |
| Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue | Placebo and Pembrolizumab 200 mg | Week 9 | 36.50 | Standard Deviation 30.373 | % positivity of tumour stromal component |
| Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue | Setanaxib 1600 mg and Pembrolizumab 200 mg | Baseline | 18.13 | Standard Deviation 8.901 | cells/High Power Field (HPF) |
| Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue | Placebo and Pembrolizumab 200 mg | Baseline | 21.34 | Standard Deviation 19.789 | cells/High Power Field (HPF) |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Setanaxib 1600 mg and Pembrolizumab 200 mg | 27 | |
| Overall Study | STARTED | Placebo and Pembrolizumab 200 mg | 28 | |
| Overall Study | COMPLETED | Setanaxib 1600 mg and Pembrolizumab 200 mg | 1 | |
| Overall Study | COMPLETED | Placebo and Pembrolizumab 200 mg | 1 | |
| Overall Study | NOT COMPLETED | Setanaxib 1600 mg and Pembrolizumab 200 mg | 26 | |
| Overall Study | NOT COMPLETED | Placebo and Pembrolizumab 200 mg | 27 |
Source ClinicalTrials.gov
Adverse events168
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 | Asthenia | General disorders | Setanaxib 1600 mg and Pembrolizumab 200 mg | 11 | 27 | 15 |
| other | Asthenia | General disorders | Placebo and Pembrolizumab 200 mg | 9 | 28 | 14 |
| other | Fatigue | General disorders | Setanaxib 1600 mg and Pembrolizumab 200 mg | 5 | 27 | 6 |
| other | Fatigue | General disorders | Placebo and Pembrolizumab 200 mg | 2 | 28 | 2 |
| other | Oedema peripheral | General disorders | Setanaxib 1600 mg and Pembrolizumab 200 mg | 2 | 27 | 2 |
| other | Oedema peripheral | General disorders | Placebo and Pembrolizumab 200 mg | 2 | 28 | 2 |
| other | Pyrexia | General disorders | Setanaxib 1600 mg and Pembrolizumab 200 mg | 4 | 27 | 4 |
| other | Pyrexia | General disorders | Placebo and Pembrolizumab 200 mg | 1 | 28 | 1 |
| other | Implant site extravasation | General disorders | Setanaxib 1600 mg and Pembrolizumab 200 mg | 2 | 27 | 4 |
| other | Implant site extravasation | General disorders | Placebo and Pembrolizumab 200 mg | 0 | 28 | 0 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Setanaxib 1600 mg and Pembrolizumab 200 mg | 6 | 27 |
| Total, all-cause mortality | Placebo and Pembrolizumab 200 mg | 13 | 28 |
| Total, other adverse events | Setanaxib 1600 mg and Pembrolizumab 200 mg | 27 | 27 |
| Total, other adverse events | Placebo and Pembrolizumab 200 mg | 23 | 28 |
| Total, serious adverse events | Setanaxib 1600 mg and Pembrolizumab 200 mg | 8 | 27 |
| Total, serious adverse events | Placebo and Pembrolizumab 200 mg | 10 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Setanaxib 1600 mg and Pembrolizumab 200 mg vs Placebo and Pembrolizumab 200 mg: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Setanaxib 1600 mg and Pembrolizumab 200 mg vs Placebo and Pembrolizumab 200 mg: deaths from any cause | Trial comparisons |
| Setanaxib 1600 mg and Pembrolizumab 200 mg vs Placebo and Pembrolizumab 200 mg: Number of Participants With Adverse Events of Special Interest (AESI) | Trial comparisons |
| Setanaxib 1600 mg and Pembrolizumab 200 mg vs Placebo and Pembrolizumab 200 mg: 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.
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/NCT05323656
GET https://conductscience.org/api/trials/v1/NCT05323656/registered?page=2