Trial · NCT03284424
Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)
NCT03284424, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2021-11-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629). Trials, record NCT03284424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03284424
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)
- NCT number
- NCT03284424
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 159 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Squamous Cell Carcinoma
- Interventions
- Pembrolizumab
- First posted
- 2017-09-15
- Last updated
- 2024-08-23
- Other registries' IDs
- eudract:2017-000594-37
- Results first posted
- 2021-11-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to approximately 32 months | ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) is presented. |
| Secondary | Duration of Response (DOR) | Up to approximately 56 months | For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 as assessed by BICR is presented for all participants who experienced a confirmed CR or PR. |
| Secondary | Disease Control Rate (DCR) | Up to approximately 56 months | DCR is defined as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease). The DCR per RECIST 1.1 as assessed by BICR is presented. |
| Secondary | Progression-free Survival (PFS) | Up to approximately 56 months | PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause, whichever occurred first. PFS per RECIST 1.1 as assessed by BICR is presented. |
| Secondary | Overall Survival (OS) | Up to approximately 56 months | OS was defined as the time from first dose of study treatment to death due to any cause. The OS for all participants is presented. |
| Secondary | Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 56 months | An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who experienced an AE is presented. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to AE | Up to approximately 56 months | An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who discontinued study treatment due to an AE is presented. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Up to approximately 32 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approximately 56 months | The analysis population consisted of all participants who received ≥1 dose of study treatment and had confirmed complete response or partial response. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 56 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Up to approximately 56 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 56 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 56 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to AE | Up to approximately 56 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Recurrent or Metastatic Cutaneous cSCC Cohort | 35.2 | 95% Confidence Interval 26.2 to 45.2 | Percentage of participants | |
| Objective Response Rate (ORR) | Locally Advanced Unresectable cSCC Cohort | 51.9 | 95% Confidence Interval 37.8 to 65.7 | Percentage of participants | |
| Duration of Response (DOR) | Recurrent or Metastatic Cutaneous cSCC Cohort | 1.6 | Full Range 1.2 to 24.7 | Months | |
| Duration of Response (DOR) | Locally Advanced Unresectable cSCC Cohort | 2.7 | Full Range 1.1 to 12.3 | Months | |
| Disease Control Rate (DCR) | Recurrent or Metastatic Cutaneous cSCC Cohort | 52.4 | 95% Confidence Interval 42.4 to 62.2 | Percentage of participants | |
| Disease Control Rate (DCR) | Locally Advanced Unresectable cSCC Cohort | 64.8 | 95% Confidence Interval 50.6 to 77.3 | Percentage of participants | |
| Progression-free Survival (PFS) | Recurrent or Metastatic Cutaneous cSCC Cohort | 5.7 | 95% Confidence Interval 3.1 to 8.5 | Months | |
| Progression-free Survival (PFS) | Locally Advanced Unresectable cSCC Cohort | 14.4 | 95% Confidence Interval 5.5 to 43.6 | Months | |
| Overall Survival (OS) | Recurrent or Metastatic Cutaneous cSCC Cohort | 23.8 | 95% Confidence Interval 13.4 to 30.9 | Months | |
| Overall Survival (OS) | Locally Advanced Unresectable cSCC Cohort | NA | 95% Confidence Interval 33.3 to NA | Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort | 105 | |
| Overall Study | STARTED | Locally Advanced Unresectable cSCC Cohort | 54 | |
| Overall Study | Participants That Received a Second Course of Pembrolizumab | Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort | 2 | |
| Overall Study | Participants That Received a Second Course of Pembrolizumab | Locally Advanced Unresectable cSCC Cohort | 1 | |
| Overall Study | COMPLETED | Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort | 0 | |
| Overall Study | COMPLETED | Locally Advanced Unresectable cSCC Cohort | 0 | |
| Overall Study | NOT COMPLETED | Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort | 105 | |
| Overall Study | NOT COMPLETED | Locally Advanced Unresectable cSCC Cohort | 54 |
Source ClinicalTrials.gov
Adverse events322
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 | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | 18 | 159 | 26 |
| other | Anaemia | Blood and lymphatic system disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 0 | 3 | 0 |
| other | Hypothyroidism | Endocrine disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | 14 | 159 | 16 |
| other | Hypothyroidism | Endocrine disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | 13 | 159 | 14 |
| other | Abdominal pain | Gastrointestinal disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 0 | 3 | 0 |
| other | Constipation | Gastrointestinal disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | 40 | 159 | 47 |
| other | Constipation | Gastrointestinal disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 0 | 3 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | 31 | 159 | 38 |
| other | Diarrhoea | Gastrointestinal disorders | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 1 | 3 | 1 |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | 97 | 159 |
| Total, all-cause mortality | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 1 | 3 |
| Total, other adverse events | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | 139 | 159 |
| Total, other adverse events | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 2 | 3 |
| Total, serious adverse events | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | 87 | 159 |
| Total, serious adverse events | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 2 | 3 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Recurrent or Metastatic Cutaneous cSCC Cohort vs Locally Advanced Unresectable cSCC Cohort: Number of Participants Who Experienced One or More Adverse Events (AEs) | Trial comparisons |
| Recurrent or Metastatic Cutaneous cSCC Cohort vs Locally Advanced Unresectable cSCC Cohort: Number of Participants Who Discontinued Study Treatment Due to AE | Trial comparisons |
| Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course vs Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course: deaths from any cause | Trial comparisons |
| Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course vs Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course: 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/NCT03284424
GET https://conductscience.org/api/trials/v1/NCT03284424/events?page=2