Trial · NCT04808999
Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)
NCT04808999, Phase 2, Active not recruiting, Diwakar Davar; results first posted 2025-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC). Trials, record NCT04808999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04808999
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)
- NCT number
- NCT04808999
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Diwakar Davar
- Conditions
- Squamous Cell Carcinoma
- Interventions
- Pembrolizumab Injection
- First posted
- 2021-03-22
- Last updated
- 2026-10-20
- Results first posted
- 2025-05-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Response | At time of surgery, up to 6 weeks post-baseline | Percentage of patients in each pathologic response category per Immune-Related Pathologic Response Criteria (irPRC). Pathologic complete response (pCR) means there was 0% residual tumor volume (RVT) in the post-treatment surgical specimen. Pathologic major response (pMR) means there was \>0% but ≤10% RVT in the post-treatment surgical specimen. Pathologic partial pathologic response (pPR) means there was \>10% but ≤50% RVT in the post-treatment surgical specimen. Pathologic non-response (pNR) means there was \>50% RVT in the post-treatment surgical specimen. |
| Secondary | 6-month Relapse-Free Survival (RFS) | Up to 6 months from start of study treatment | The percentage of patients whose disease does not progress/relapse (as defined by RECIST v1.1), or cease to breath at 6 months after the initiation of treatment. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. |
| Secondary | 1-year OS | Up to 12 months | The percentage of patients alive at 1 year after the initiation of treatment. |
| Secondary | 1-year Relapse-Free Survival (RFS) | Up to 12 months from start of study treatment | The percentage of patients whose disease does not progress/relapse (as defined by RECIST v1.1), or cease to breath at 1 year after the initiation of treatment. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. |
| Secondary | 2-year OS | Up to 24 months | The percentage of patients alive at 2 years after the initiation of treatment. |
| Secondary | 2-year Relapse-Free Survival (RFS) | Up to 24 months from start of study treatment | The percentage of patients whose disease does not relapse/progress (as defined by RECIST v1.1), or cease to breath at 2 years after the initiation of treatment. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. |
| Secondary | 3-year Relapse-Free Survival (RFS) | Up to 36 months from start of study treatment | The percentage of patients whose disease does not progress/relapse (as defined by RECIST v1.1), or cease to breath at 3 years after the initiation of treatment. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. |
| Secondary | Relapse-free Survival (RFS) | Up to 60 months from start of study treatment | The median length of time from initiation of study drug(s) until disease relapse (disease progression) as defined by RECIST v1.1, or death. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. |
| Secondary | Overall Survival (OS) | Up to 60 months from start of treatment | The median length of time from initiation of study treatment that patients remain alive. |
Source ClinicalTrials.gov
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathologic Response | At time of surgery, up to 6 weeks post-baseline | Treated patients evaluable for pathologic complete response (pCR) at the time of their surgery. | percentage of patients | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Up to 60 months | |||
| SECONDARY | 1-year PRS | Up to 12 months | |||
| SECONDARY | 6-month PFS | Up to 6 months | |||
| SECONDARY | 2-year PFS | Up to 24 months | |||
| SECONDARY | 3-year PFS | Up to 36 months | |||
| SECONDARY | Overall Survival (OS) | Up to 84 months | |||
| SECONDARY | 1-year OS | Up to 12 months | |||
| SECONDARY | 2-year OS | Up to 24 months | |||
| SECONDARY | Pathologic Response | From start of treatment, up to 24 months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Response | Pembrolizumab | pCR | 63.0 | 95% Confidence Interval 42.4 to 80.6 | percentage of patients |
| Pathologic Response | Pembrolizumab | pPR | 7.4 | 95% Confidence Interval 0.9 to 24.3 | percentage of patients |
| Response Assessment Per Immune-Related Pathologic Response Criteria (irPRC) | Pembrolizumab | pCR | 17 | Participants | |
| Response Assessment Per Immune-Related Pathologic Response Criteria (irPRC) | Pembrolizumab | pPR | 2 | Participants | |
| Response Assessment Per Immune-Related Pathologic Response Criteria (irPRC) | Pembrolizumab | pNR | 8 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab | 30 | |
| Overall Study | COMPLETED | Pembrolizumab | 30 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 0 |
Source ClinicalTrials.gov
Adverse events176
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 | Anemia | Blood and lymphatic system disorders | Pembrolizumab | 17 | 30 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Pembrolizumab | 4 | 30 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Pembrolizumab | 2 | 30 | |
| other | Aortic valve disease | Cardiac disorders | Pembrolizumab | 1 | 30 | |
| other | coronary artery disease | Cardiac disorders | Pembrolizumab | 1 | 30 | |
| other | Heart failure | Cardiac disorders | Pembrolizumab | 1 | 30 | |
| other | Sinus bradycardia | Cardiac disorders | Pembrolizumab | 5 | 30 | |
| other | Sinus tachycardia | Cardiac disorders | Pembrolizumab | 4 | 30 | |
| other | ear congestion | Ear and labyrinth disorders | Pembrolizumab | 1 | 30 | |
| other | Hearing impaired | Ear and labyrinth disorders | Pembrolizumab | 1 | 30 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab | 6 | 30 |
| Total, other adverse events | Pembrolizumab | 29 | 30 |
| Total, serious adverse events | Pembrolizumab | 13 | 30 |
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 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.
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/NCT04808999
GET https://conductscience.org/api/trials/v1/NCT04808999/events?page=2