18 and older, any sex, with Recurrent Merkel Cell Carcinoma or Stage III Merkel Cell Carcinoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 1.1Primary· 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.
Number participants with partial response (PR)
Group
Value
95% CI
Treatment (Pembrolizumab)
16
Number participants with complete response (CR)
Group
Value
95% CI
Treatment (Pembrolizumab)
12
Combined total participants with either PR or CR
Group
Value
95% CI
Treatment (Pembrolizumab)
28
Progression-free Survival (PFS) Using RECIST 1.1Secondary· 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.
Group
Value
95% CI
Treatment (Pembrolizumab)
49.9
Duration of Response (DOR)Secondary· 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.
Group
Value
95% CI
Treatment (Pembrolizumab)
NA
4.0 – 77.4
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Treatment (Pembrolizumab)
47.2
26 – 68.4
Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0Secondary· 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.
Grade 3-5 Adverse Events
Group
Value
95% CI
Treatment (Pembrolizumab)
29
Grade 3-5 Drug Related Adverse Events
Group
Value
95% CI
Treatment (Pembrolizumab)
15
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious Adverse Events and other (not including serious) adverse events were assessed for up to 36 months. All cause mortality was assessed for up to 60 months..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Pembrolizumab)
Serious: 22/50 (44%)
Deaths: 16/50
Serious adverse events (53 terms)
Reaction
System
Treatment (Pembrolizumab)
Disease progression
General disorders
—
Dehydration
Metabolism and nutrition disorders
—
Aspartate aminotransferase increased
Investigations
—
Embolism
Vascular disorders
—
Small intestinal haemorrhage
Gastrointestinal disorders
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
Fatigue
General disorders
—
Pyrexia
General disorders
—
Alanine aminotransferase increased
Investigations
—
Hyperglycaemia
Metabolism and nutrition disorders
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
Rash maculo-papular
Skin and subcutaneous tissue disorders
—
Haematoma
Vascular disorders
—
Anemia
Blood and lymphatic system disorders
—
Atrial fibrillation
Cardiac disorders
—
Myocarditis
Cardiac disorders
—
Pericardial effusion
Cardiac disorders
—
Sinus bradycardia
Cardiac disorders
—
Ventricular arrhythmia
Cardiac disorders
—
Abdominal pain
Gastrointestinal disorders
—
Colitis
Gastrointestinal disorders
—
Dysphagia
Gastrointestinal disorders
—
Gastrooesophageal reflux disease
Gastrointestinal disorders
—
Small intestinal obstruction
Gastrointestinal disorders
—
Chills
General disorders
—
Other adverse events (265 terms — click to expand)
This phase II trial studies how well pembrolizumab works in treating patients with Merkel cell cancer that cannot be removed by surgery or controlled with treatment, or has spread to other parts of the body. Pembrolizumab may stimulate the immune system to identify and destroy cancer cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 5 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02267603.