Trial · NCT02267603
Pembrolizumab in Treating Patients With Advanced Merkel Cell Cancer
NCT02267603, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab in Treating Patients With Advanced Merkel Cell Cancer. Trials, record NCT02267603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02267603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab in Treating Patients With Advanced Merkel Cell Cancer
- NCT number
- NCT02267603
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Merkel Cell Carcinoma, Stage III Merkel Cell Carcinoma AJCC v7, Stage IIIA Merkel Cell Carcinoma AJCC v7, Stage IIIB Merkel Cell Carcinoma AJCC v7, Stage IV Merkel Cell Carcinoma AJCC v7
- Interventions
- Laboratory Biomarker Analysis, Pembrolizumab
- First posted
- 2014-10-17
- Last updated
- 2023-07-05
- Results first posted
- 2019-03-01
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) Defined as the Proportion of Patients Who Have Achieved Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 3 years | ORR will be estimated as the number of responders as a percent of the number of eligible participants who received at least one dose of treatment. If a substantial amount of data is missing, analyses will be performed using parametric generalized linear models fit by maximum likelihood. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes. Responses to continued pembrolizumab will be chronicled and reported. |
| Secondary | Progression-free Survival (PFS) Using RECIST 1.1 | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 16 months | Survival curves for PFS will be estimated using the Kaplan-Meier method. Assessed percentage of participants with progression free survival up to 16 months. |
| Secondary | Duration of Response (DOR) | Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 3 years | Survival curves for DOR will be estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | Time interval between the start of treatment to death due to any cause, assessed up to 60 months. | Survival curves for OS will be estimated using the Kaplan-Meier method. |
| Secondary | Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Up to 90 days post-treatment | Safety will be assessed by quantifying the toxicities and grades experienced by subjects including serious AEs (SAEs) and events of clinical interest. Safety and tolerability will be assessed by clinical review of all relevant parameters including AEs, laboratory tests, vital signs, and electrocardiogram measurements. Assessed number of participants who experienced grade 3 to 5 adverse events. |
| Other | Immune Correlates of the Clinical Activity of Pembrolizumab | Baseline | This will include immunohistochemical and gene expression analysis focusing on delineating the immune components and immunologic milieu within the tumor before therapy. |
| Other | Merkel Polyomavirus (MCPyV)-Specific Immune Response, Assessed With Enzyme-linked Immunosorbent Spot and Serology Assays | After 2 years of treatment | Responses will be assessed at baseline, after initiating therapy, and correlated with clinical responses over time. Among patients with corresponding MHC-peptide tetramers, pre- and post-treatment samples of circulating MCPyV-specific CD8 T cells will be isolated and subjected to deep immunophenotyping by messenger ribonucleic acid (mRNA) expression analysis. |
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) Defined as the Proportion of Patients Who Have Achieved Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) Using RECIST 1.1 | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 16 months | % of participants | NUMBER | |
| SECONDARY | Duration of Response (DOR) | Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 3 years | Thirty participants with durable response were assessed by RECIST 1.1. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time interval between the start of treatment to death due to any cause, assessed up to 60 months. | months | MEDIAN | |
| SECONDARY | Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Up to 90 days post-treatment | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Immune Correlates of the Clinical Activity of Pembrolizumab | Baseline | |||
| OTHER_PRE_SPECIFIED | Merkel Polyomavirus (MCPyV)-Specific Immune Response, Assessed With Enzyme-linked Immunosorbent Spot and Serology Assays | After 2 years of treatment |
Source ClinicalTrials.gov
Results by group8
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) Defined as the Proportion of Patients Who Have Achieved Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Treatment (Pembrolizumab) | Number participants with partial response (PR) | 16 | Participants | |
Objective Response Rate (ORR) Defined as the Proportion of Patients Who Have Achieved Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Treatment (Pembrolizumab) | Number participants with complete response (CR) | 12 | Participants | |
Objective Response Rate (ORR) Defined as the Proportion of Patients Who Have Achieved Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Treatment (Pembrolizumab) | Combined total participants with either PR or CR | 28 | Participants | |
| Progression-free Survival (PFS) Using RECIST 1.1 | Treatment (Pembrolizumab) | 49.9 | % of participants | ||
| Duration of Response (DOR) | Treatment (Pembrolizumab) | NA | Full Range 4.0 to 77.4 | months | |
| Overall Survival (OS) | Treatment (Pembrolizumab) | 47.2 | 95% Confidence Interval 26 to 68.4 | months | |
| Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Treatment (Pembrolizumab) | Grade 3-5 Adverse Events | 29 | Participants | |
| Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Treatment (Pembrolizumab) | Grade 3-5 Drug Related Adverse Events | 15 | 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 | Treatment (Pembrolizumab) | 50 | |
| Overall Study | COMPLETED | Treatment (Pembrolizumab) | 6 | |
| Overall Study | NOT COMPLETED | Treatment (Pembrolizumab) | 44 |
Source ClinicalTrials.gov
Adverse events318
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 | Treatment (Pembrolizumab) | 16 | 50 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 3 | 50 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 2 | 50 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 1 | 50 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 1 | 50 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 1 | 50 | |
| other | Microcytic anaemia | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 1 | 50 | |
| other | Monocytosis | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 1 | 50 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 2 | 50 | |
| other | Acute myocardial infarction | Cardiac disorders | Treatment (Pembrolizumab) | 1 | 50 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pembrolizumab) | 16 | 50 |
| Total, other adverse events | Treatment (Pembrolizumab) | 50 | 50 |
| Total, serious adverse events | Treatment (Pembrolizumab) | 22 | 50 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| K24CA139052 | Pathogenetic and prognostic studies for improved therapy of Merkel cell carcinoma | NGHIEM, PAUL | UNIVERSITY OF WASHINGTON | NATIONAL CANCER INSTITUTE | 2009 to 2018 | NIH RePORTER |
| U01CA154967 | Cancer Immunotherapy Trials Network Central Operations and Statistical Center | CHEEVER, MARTIN ALEXANDER | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL CANCER INSTITUTE | 2010 to 2017 | NIH RePORTER |
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/NCT02267603
GET https://conductscience.org/api/trials/v1/NCT02267603/events?page=2