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Pembrolizumab in Treating Patients With Advanced Merkel Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267603
Recruitment Status : Active, not recruiting
First Posted : October 17, 2014
Results First Posted : March 1, 2019
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
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 Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Pembrolizumab)
Hide Arm/Group Description

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression* or unacceptable toxicity.

* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.

Laboratory Biomarker Analysis: Ancillary studies

Pembrolizumab: Given IV

Period Title: Overall Study
Started 50
Completed 6
Not Completed 44
Arm/Group Title Treatment (Pembrolizumab)
Hide Arm/Group Description

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression* or unacceptable toxicity.

* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.

Laboratory Biomarker Analysis: Ancillary studies

Pembrolizumab: Given IV

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
  80.0%
>=65 years
10
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
16
  32.0%
Male
34
  68.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
45
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
4
   8.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Pembrolizumab)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression* or unacceptable toxicity.

* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.

Laboratory Biomarker Analysis: Ancillary studies

Pembrolizumab: Given IV

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
Number participants with partial response (PR)
16
  32.0%
Number participants with complete response (CR)
12
  24.0%
Combined total participants with either PR or CR
28
  56.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Pembrolizumab)
Comments The protocol has a standard Simon two stage design. The null hypothesis that the true response rate is 5% will be tested against a one-sided alternative. In the first stage, 9 patients will be accrued. If there are no responses in these 9 patients, the study will be stopped. Otherwise, 15 additional patients will be accrued for a total of 24. The current protocol will increase the total number of patients from 26 to 50.
Type of Statistical Test Other
Comments The null hypothesis will be rejected if 3 or more responses are observed in 24 patients. This design yields a type I error rate of 0.10 and power of 0.90 when the true response rate is 25%. Progression-free survival (PFS) at 16 months will be estimated by Kaplan-Meier method. Unless otherwise stated, all statistical tests will be conducted at the α=0.05 (1-sided) level.
Other Statistical Analysis ORR will be estimated as the # of responders as a % of the # of eligible participants who received at least 1 dose of treatment. If a substantial amount of primary endpoint data are missing (at least 1 value missing from more than 20% of participants), using nonparametric estimation to estimate the ORR requires the missing completely at random assumption may give misleading results. In this case, analyses of the primary endpoint will be performed using parametric generalized linear models fit by maximum likelihood. These methods provide unbiased estimation and inferences under the parametric modeling assumptions and the assumption that the missing data are missing at random (MAR). MAR assumes that the probability of an observation being missing may depend upon the observed responses and upon observed covariates. 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.
2.Secondary Outcome
Title Progression-free Survival (PFS) Using RECIST 1.1
Hide Description Survival curves for PFS will be estimated using the Kaplan-Meier method.
Time Frame Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 16 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Survival curves for DOR will be estimated using the Kaplan-Meier method.
Time Frame Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 3 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Survival curves for OS will be estimated using the Kaplan-Meier method.
Time Frame Time interval between the start of treatment to death due to any cause, assessed up to 3 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Hide Description 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. Adverse experiences will be summarized as counts and frequencies by toxicity grade. Summary statistics (median and range) for time to onset of first drug-related toxicity will be provided.
Time Frame Up to 90 days post-treatment
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Immune Correlates of the Clinical Activity of Pembrolizumab
Hide Description This will include immunohistochemical and gene expression analysis focusing on delineating the immune components and immunologic milieu within the tumor before therapy.
Time Frame Baseline
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Merkel Polyomavirus (MCPyV)-Specific Immune Response, Assessed With Enzyme-linked Immunosorbent Spot and Serology Assays
Hide Description 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.
Time Frame After 2 years of treatment
Outcome Measure Data Not Reported
Time Frame 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Pembrolizumab)
Hide Arm/Group Description

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression* or unacceptable toxicity.

* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.

Laboratory Biomarker Analysis: Ancillary studies

Pembrolizumab: Given IV

All-Cause Mortality
Treatment (Pembrolizumab)
Affected / at Risk (%)
Total   16/50 (32.00%) 
Hide Serious Adverse Events
Treatment (Pembrolizumab)
Affected / at Risk (%)
Total   22/50 (44.00%) 
Blood and lymphatic system disorders   
Anemia   1/50 (2.00%) 
Cardiac disorders   
Atrial fibrillation   1/50 (2.00%) 
Myocarditis   1/50 (2.00%) 
Pericardial effusion   1/50 (2.00%) 
Sinus bradycardia   1/50 (2.00%) 
Ventricular arrhythmia   1/50 (2.00%) 
Gastrointestinal disorders   
Abdominal pain   1/50 (2.00%) 
Colitis   1/50 (2.00%) 
Dysphagia   1/50 (2.00%) 
Gastrooesophageal reflux disease   1/50 (2.00%) 
Small intestinal haemorrhage   2/50 (4.00%) 
Small intestinal obstruction   1/50 (2.00%) 
Upper gastrointestinal haemorrhage   2/50 (4.00%) 
General disorders   
Chills   1/50 (2.00%) 
Disease progression   8/50 (16.00%) 
Fatigue   2/50 (4.00%) 
Malaise   1/50 (2.00%) 
Pyrexia   2/50 (4.00%) 
Infections and infestations   
Lung infection   1/50 (2.00%) 
Mastitis   1/50 (2.00%) 
Sepsis   1/50 (2.00%) 
Sialoadenitis   1/50 (2.00%) 
Streptococcal bacteraemia   1/50 (2.00%) 
Tuberculosis   1/50 (2.00%) 
Urinary tract infection   1/50 (2.00%) 
Investigations   
Alanine aminotransferase increased   2/50 (4.00%) 
Aspartate aminotransferase increased   3/50 (6.00%) 
Blood alkaline phosphatase increased   1/50 (2.00%) 
Blood bilirubin increased   1/50 (2.00%) 
Metabolism and nutrition disorders   
Acidosis   1/50 (2.00%) 
Decreased appetite   1/50 (2.00%) 
Dehydration   4/50 (8.00%) 
Hypercalcaemia   1/50 (2.00%) 
Hyperglycaemia   2/50 (4.00%) 
Hypernatraemia   1/50 (2.00%) 
Hyperuricaemia   1/50 (2.00%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness   1/50 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer pain   1/50 (2.00%) 
Paraneoplastic syndrome   1/50 (2.00%) 
Tumour pain   1/50 (2.00%) 
Psychiatric disorders   
Delirium   1/50 (2.00%) 
Renal and urinary disorders   
Acute kidney injury   1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   1/50 (2.00%) 
Epistaxis   1/50 (2.00%) 
Hypoxia   1/50 (2.00%) 
Pleural effusion   1/50 (2.00%) 
Pneumonitis   2/50 (4.00%) 
Skin and subcutaneous tissue disorders   
Lichenoid keratosis   1/50 (2.00%) 
Pain of skin   1/50 (2.00%) 
Rash maculo-papular   2/50 (4.00%) 
Vascular disorders   
Embolism   3/50 (6.00%) 
Haematoma   2/50 (4.00%) 
Hypotension   1/50 (2.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Treatment (Pembrolizumab)
Affected / at Risk (%)
Total   50/50 (100.00%) 
Blood and lymphatic system disorders   
Anaemia   16/50 (32.00%) 
Leukocytosis   3/50 (6.00%) 
Leukopenia   2/50 (4.00%) 
Lymph node pain   1/50 (2.00%) 
Lymphadenopathy   1/50 (2.00%) 
Lymphopenia   1/50 (2.00%) 
Microcytic anaemia   1/50 (2.00%) 
Monocytosis   1/50 (2.00%) 
Thrombocytopenia   2/50 (4.00%) 
Cardiac disorders   
Acute myocardial infarction   1/50 (2.00%) 
Atrial fibrillation   1/50 (2.00%) 
Bundle branch block left   1/50 (2.00%) 
Cardiac failure acute   1/50 (2.00%) 
Palpitations   1/50 (2.00%) 
Sinus bradycardia   1/50 (2.00%) 
Sinus tachycardia   1/50 (2.00%) 
Tachycardia   1/50 (2.00%) 
Ventricular tachycardia   1/50 (2.00%) 
Ear and labyrinth disorders   
Deafness   1/50 (2.00%) 
Hypoacusis   2/50 (4.00%) 
Paraesthesia ear   1/50 (2.00%) 
Endocrine disorders   
Adrenal insufficiency   1/50 (2.00%) 
Adrenocorticotropic hormone deficiency   1/50 (2.00%) 
Autoimmune hypothyroidism   2/50 (4.00%) 
Hyperthyroidism   1/50 (2.00%) 
Hypothyroidism   3/50 (6.00%) 
Thyroiditis   1/50 (2.00%) 
Eye disorders   
Asthenopia   1/50 (2.00%) 
Diplopia   1/50 (2.00%) 
Eyelid ptosis   1/50 (2.00%) 
Ophthalmoplegia   1/50 (2.00%) 
Vision blurred   1/50 (2.00%) 
Visual acuity reduced   1/50 (2.00%) 
Visual impairment   2/50 (4.00%) 
Vitreous floaters   2/50 (4.00%) 
Gastrointestinal disorders   
Abdominal discomfort   3/50 (6.00%) 
Abdominal distension   1/50 (2.00%) 
Abdominal pain   5/50 (10.00%) 
Abdominal pain upper   2/50 (4.00%) 
Aphthous ulcer   1/50 (2.00%) 
Breath odour   1/50 (2.00%) 
Colitis   1/50 (2.00%) 
Constipation   14/50 (28.00%) 
Diarrhoea   11/50 (22.00%) 
Dry mouth   2/50 (4.00%) 
Dyspepsia   1/50 (2.00%) 
Dysphagia   1/50 (2.00%) 
Faeces discoloured   1/50 (2.00%) 
Gastrointestinal haemorrhage   1/50 (2.00%) 
Gastrointestinal pain   1/50 (2.00%) 
Gastrooesophageal reflux disease   4/50 (8.00%) 
Haemorrhoids   1/50 (2.00%) 
Intra-abdominal haematoma   1/50 (2.00%) 
Large intestine polyp   1/50 (2.00%) 
Lower gastrointestinal haemorrhage   1/50 (2.00%) 
Nausea   10/50 (20.00%) 
Oesophageal varices haemorrhage   1/50 (2.00%) 
Pancreatitis   2/50 (4.00%) 
Stomatitis   1/50 (2.00%) 
Vomiting   5/50 (10.00%) 
General disorders   
Asthenia   2/50 (4.00%) 
Chest discomfort   1/50 (2.00%) 
Chest pain   1/50 (2.00%) 
Chills   4/50 (8.00%) 
Cyst   1/50 (2.00%) 
Face oedema   1/50 (2.00%) 
Fatigue   28/50 (56.00%) 
Feeling cold   1/50 (2.00%) 
Feeling hot   2/50 (4.00%) 
Gait disturbance   1/50 (2.00%) 
Malaise   1/50 (2.00%) 
Nodule   1/50 (2.00%) 
Oedema   1/50 (2.00%) 
Oedema peripheral   4/50 (8.00%) 
Pain   1/50 (2.00%) 
Peripheral swelling   4/50 (8.00%) 
Pyrexia   7/50 (14.00%) 
Swelling   2/50 (4.00%) 
Temperature intolerance   2/50 (4.00%) 
Hepatobiliary disorders   
Autoimmune hepatitis   1/50 (2.00%) 
Cholecystitis   1/50 (2.00%) 
Hyperbilirubinaemia   1/50 (2.00%) 
Immune system disorders   
Seasonal allergy   1/50 (2.00%) 
Infections and infestations   
Abdominal hernia infection   1/50 (2.00%) 
Abscess limb   1/50 (2.00%) 
Breast cellulitis   1/50 (2.00%) 
Bronchitis   1/50 (2.00%) 
Cellulitis   3/50 (6.00%) 
Conjunctivitis   1/50 (2.00%) 
Diverticulitis   1/50 (2.00%) 
Eye infection   1/50 (2.00%) 
Fungal infection   1/50 (2.00%) 
Gastrointestinal infection   1/50 (2.00%) 
Genital herpes   1/50 (2.00%) 
Herpes virus infection   1/50 (2.00%) 
Herpes zoster   4/50 (8.00%) 
Lung infection   1/50 (2.00%) 
Nasopharyngitis   3/50 (6.00%) 
Oral candidiasis   3/50 (6.00%) 
Oral herpes   1/50 (2.00%) 
Sinusitis   3/50 (6.00%) 
Skin infection   1/50 (2.00%) 
Soft tissue infection   1/50 (2.00%) 
Streptococcal infection   1/50 (2.00%) 
Upper respiratory tract infection   14/50 (28.00%) 
Urinary tract infection   6/50 (12.00%) 
Vaginal infection   1/50 (2.00%) 
Injury, poisoning and procedural complications   
Contusion   3/50 (6.00%) 
Excoriation   1/50 (2.00%) 
Fall   3/50 (6.00%) 
Infusion related reaction   1/50 (2.00%) 
Tooth fracture   1/50 (2.00%) 
Investigations   
Alanine aminotransferase increased   11/50 (22.00%) 
Amylase increased   1/50 (2.00%) 
Aspartate aminotransferase increased   8/50 (16.00%) 
Blood alkaline phosphatase decreased   1/50 (2.00%) 
Blood alkaline phosphatase increased   7/50 (14.00%) 
Blood bilirubin increased   4/50 (8.00%) 
Blood creatine phosphokinase increased   2/50 (4.00%) 
Blood creatinine increased   6/50 (12.00%) 
Blood glucose increased   1/50 (2.00%) 
Blood lactate dehydrogenase increased   1/50 (2.00%) 
Blood magnesium increased   1/50 (2.00%) 
Blood pressure increased   1/50 (2.00%) 
Blood testosterone decreased   1/50 (2.00%) 
Blood thyroid stimulating hormone increased   1/50 (2.00%) 
Blood urea increased   1/50 (2.00%) 
Blood urine present   1/50 (2.00%) 
Lipase increased   1/50 (2.00%) 
Lymphocyte count decreased   7/50 (14.00%) 
Neutrophil count decreased   1/50 (2.00%) 
Neutrophil count increased   1/50 (2.00%) 
Platelet count decreased   2/50 (4.00%) 
Sputum normal   1/50 (2.00%) 
Thyroxine free increased   2/50 (4.00%) 
Weight decreased   5/50 (10.00%) 
White blood cell count decreased   5/50 (10.00%) 
Metabolism and nutrition disorders   
Decreased appetite   11/50 (22.00%) 
Dehydration   1/50 (2.00%) 
Hypercalcaemia   2/50 (4.00%) 
Hyperchloraemia   2/50 (4.00%) 
Hyperglycaemia   11/50 (22.00%) 
Hyperkalaemia   4/50 (8.00%) 
Hypernatraemia   1/50 (2.00%) 
Hyperuricaemia   1/50 (2.00%) 
Hypoalbuminaemia   4/50 (8.00%) 
Hypocalcaemia   7/50 (14.00%) 
Hypochloraemia   2/50 (4.00%) 
Hypokalaemia   5/50 (10.00%) 
Hypomagnesaemia   1/50 (2.00%) 
Hyponatraemia   10/50 (20.00%) 
Hypophosphataemia   2/50 (4.00%) 
Hypoproteinaemia   2/50 (4.00%) 
Hypovitaminosis   1/50 (2.00%) 
Increased appetite   1/50 (2.00%) 
Malnutrition   1/50 (2.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   7/50 (14.00%) 
Back pain   4/50 (8.00%) 
Bone pain   1/50 (2.00%) 
Flank pain   1/50 (2.00%) 
Groin pain   1/50 (2.00%) 
Joint range of motion decreased   1/50 (2.00%) 
Muscle fatigue   1/50 (2.00%) 
Muscle twitching   1/50 (2.00%) 
Muscular weakness   5/50 (10.00%) 
Musculoskeletal discomfort   1/50 (2.00%) 
Musculoskeletal pain   3/50 (6.00%) 
Myalgia   6/50 (12.00%) 
Neck mass   1/50 (2.00%) 
Osteoarthritis   2/50 (4.00%) 
Pain in extremity   3/50 (6.00%) 
Polyarthritis   1/50 (2.00%) 
Rotator cuff syndrome   1/50 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma   1/50 (2.00%) 
Lipoma   1/50 (2.00%) 
Melanocytic naevus   1/50 (2.00%) 
Paraneoplastic syndrome   1/50 (2.00%) 
Squamous cell carcinoma   3/50 (6.00%) 
Transitional cell carcinoma   1/50 (2.00%) 
Tumour pain   2/50 (4.00%) 
Nervous system disorders   
Burning sensation   2/50 (4.00%) 
Cerebral ischaemia   1/50 (2.00%) 
Dizziness   8/50 (16.00%) 
Dysgeusia   4/50 (8.00%) 
Encephalopathy   1/50 (2.00%) 
Headache   10/50 (20.00%) 
Hyperaesthesia   2/50 (4.00%) 
Hypoaesthesia   3/50 (6.00%) 
Lethargy   2/50 (4.00%) 
Memory impairment   1/50 (2.00%) 
Nystagmus   1/50 (2.00%) 
Paraesthesia   3/50 (6.00%) 
Peripheral motor neuropathy   1/50 (2.00%) 
Peripheral sensory neuropathy   1/50 (2.00%) 
Sciatica   3/50 (6.00%) 
Syncope   1/50 (2.00%) 
Tremor   2/50 (4.00%) 
Psychiatric disorders   
Anxiety   1/50 (2.00%) 
Confusional state   1/50 (2.00%) 
Delirium   1/50 (2.00%) 
Disorientation   1/50 (2.00%) 
Insomnia   2/50 (4.00%) 
Irritability   2/50 (4.00%) 
Mental status changes   2/50 (4.00%) 
Mood altered   1/50 (2.00%) 
Sleep disorder   4/50 (8.00%) 
Renal and urinary disorders   
Acute kidney injury   1/50 (2.00%) 
Dysuria   2/50 (4.00%) 
Glycosuria   2/50 (4.00%) 
Haematuria   3/50 (6.00%) 
Nephritis   1/50 (2.00%) 
Nephrolithiasis   1/50 (2.00%) 
Pollakiuria   1/50 (2.00%) 
Proteinuria   1/50 (2.00%) 
Urinary retention   1/50 (2.00%) 
Urinary tract pain   1/50 (2.00%) 
Reproductive system and breast disorders   
Breast pain   3/50 (6.00%) 
Breast swelling   2/50 (4.00%) 
Oedema genital   1/50 (2.00%) 
Pruritus genital   1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough   11/50 (22.00%) 
Dysphonia   4/50 (8.00%) 
Dyspnoea   8/50 (16.00%) 
Haemoptysis   1/50 (2.00%) 
Hypercapnia   1/50 (2.00%) 
Nasal congestion   8/50 (16.00%) 
Nasal polyps   1/50 (2.00%) 
Oropharyngeal pain   3/50 (6.00%) 
Pneumonitis   1/50 (2.00%) 
Productive cough   1/50 (2.00%) 
Respiratory tract congestion   1/50 (2.00%) 
Rhinorrhoea   1/50 (2.00%) 
Sinus congestion   1/50 (2.00%) 
Skin and subcutaneous tissue disorders   
Actinic keratosis   3/50 (6.00%) 
Alopecia   1/50 (2.00%) 
Dry skin   2/50 (4.00%) 
Eczema   2/50 (4.00%) 
Erythema   1/50 (2.00%) 
Hair growth abnormal   1/50 (2.00%) 
Hypotrichosis   1/50 (2.00%) 
Itching scar   1/50 (2.00%) 
Lichen planus   1/50 (2.00%) 
Lichenoid keratosis   2/50 (4.00%) 
Night sweats   2/50 (4.00%) 
Papule   1/50 (2.00%) 
Pruritus   11/50 (22.00%) 
Pruritus generalised   1/50 (2.00%) 
Psoriasis   1/50 (2.00%) 
Rash   11/50 (22.00%) 
Rash erythematous   2/50 (4.00%) 
Rash maculo-papular   7/50 (14.00%) 
Rash pruritic   2/50 (4.00%) 
Skin burning sensation   1/50 (2.00%) 
Skin hyperpigmentation   1/50 (2.00%) 
Skin lesion   1/50 (2.00%) 
Surgical and medical procedures   
Cancer surgery   1/50 (2.00%) 
Cataract operation   1/50 (2.00%) 
Vascular disorders   
Deep vein thrombosis   1/50 (2.00%) 
Embolism   1/50 (2.00%) 
Haematoma   2/50 (4.00%) 
Hot flush   5/50 (10.00%) 
Hypertension   6/50 (12.00%) 
Hypotension   4/50 (8.00%) 
Lymphoedema   1/50 (2.00%) 
Phlebitis   1/50 (2.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alisa Claeys
Organization: Cancer Immunotherapy Trials Network
Phone: 206-667-7607
EMail: aclaeys@fredhutch.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02267603    
Other Study ID Numbers: NCI-2014-00848
NCI-2014-00848 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MK-3475
CITN-09
CITN-09 ( Other Identifier: Cancer Immunotherapy Trials Network )
CITN-09 ( Other Identifier: CTEP )
K24CA139052 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
U01CA154967 ( U.S. NIH Grant/Contract )
First Submitted: October 14, 2014
First Posted: October 17, 2014
Results First Submitted: February 5, 2019
Results First Posted: March 1, 2019
Last Update Posted: March 22, 2021