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An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread (CheckMate 627)

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ClinicalTrials.gov Identifier: NCT02832167
Recruitment Status : Active, not recruiting
First Posted : July 14, 2016
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Intervention Biological: Nivolumab
Enrollment 239
Recruitment Details  
Pre-assignment Details 239 participants were treated.
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Period Title: Treatment Period 1
Started 239
Completed 110
Not Completed 129
Reason Not Completed
Disease progression             92
Adverse event unrelated to study drug             11
Death             1
Study Drug Toxicity             6
Participant request to discontinue             9
No longer meet study criteria             1
Participant withdrew consent             3
Other reasons             6
Period Title: Transition From Period 1 to Period 2
Started 110
Completed [1] 103
Not Completed 7
Reason Not Completed
Other reasons             1
Participant withdrew consent             1
Death             2
Lost to Follow-up             3
[1]
Completed = moved to Treatment Period 2
Period Title: Treatment Period 2
Started 103
Completed [1] 20
Not Completed 83
Reason Not Completed
Disease progression             68
Adverse event unrelated to study drug             1
Maximum clinical benefit             1
Study Drug Toxicity             5
Participant request to discontinue             2
Participant withdrew consent             3
Other reasons             3
[1]
Completed = still on treatment
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Baseline Participants 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 239 participants
59.2  (13.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
Female
148
  61.9%
Male
91
  38.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
Hispanic or Latino
11
   4.6%
Not Hispanic or Latino
158
  66.1%
Unknown or Not Reported
70
  29.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
American Indian or Alaska Native
0
   0.0%
Asian
9
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
20
   8.4%
White
203
  84.9%
More than one race
0
   0.0%
Unknown or Not Reported
7
   2.9%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). Best overall response is defined as the best response designation, as determined by investigator, recorded in the specified timeframe, according to the RECIST 1.1 criteria.
Time Frame From first dose to the date of objectively documented progression (per tumor-specific response criteria) or the date of subsequent therapy, whichever occurs first (approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description:
Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Participants Analyzed 239
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of Participants
7.9
(4.9 to 12.1)
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR is defined as the time from first confirmed response (Complete Response, CR or Partial Response, PR) to the date of the first documented tumor progression (as determined by investigator) or death due to any cause, whichever occurs first.
Time Frame From the time of first confirmed response to the date of the first documented progression (approximately 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All Responders (Participants with a confirmed CR or PR)
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description:
Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: Months
16.26 [1] 
(4.50 to NA)
[1]
Upper limit not reached because of insufficient number of participants with an event
3.Secondary Outcome
Title Time to Objective Response (TTR)
Hide Description TTR is defined as the time from first dosing date to the date of the first confirmed response (Complete Response, CR or Partial Response, PR), as assessed by investigator.
Time Frame From the first dosing date to the date of the first confirmed response (approximately 10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All Responders (Participants with a confirmed CR or PR)
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description:
Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: Months
3.18  (2.212)
4.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description CBR is defined as the percentage of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) or Stable Disease (SD).
Time Frame From the first dosing date to the date of the last dose (approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description:
Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Participants Analyzed 239
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
49.8
(43.3 to 56.3)
5.Secondary Outcome
Title Overall Survival Rate at 1 Year
Hide Description Overall Survival (OS) is defined as the time from the first dosing date to the date of death. A participant who has not died will be censored at last known date alive. OS rate at 1 year is measured as the proportion of participants still alive at 1 year after first dosing, measured from Kaplan-Meier curve of OS.
Time Frame From the first dosing date to 1 year later
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Number of Participants Who Died
Hide Description Number of participants who died for any cause
Time Frame From first dose to 100 days following last dose (approximately 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description:
Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Participants Analyzed 239
Measure Type: Count of Participants
Unit of Measure: Participants
72
  30.1%
7.Secondary Outcome
Title Number of Participants Experiencing Adverse Events (AEs)
Hide Description Number of participants who experienced any grade, any cause AEs
Time Frame From first dose to 30 days following the last dose (approximately 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description:
Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Participants Analyzed 239
Measure Type: Count of Participants
Unit of Measure: Participants
234
  97.9%
8.Secondary Outcome
Title Number of Participants Experiencing Serious Adverse Events (SAEs)
Hide Description Number of participants who experienced any grade, any cause SAEs
Time Frame From first dose to 30 days following the last dose (approximately 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description:
Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Participants Analyzed 239
Measure Type: Count of Participants
Unit of Measure: Participants
115
  48.1%
9.Secondary Outcome
Title Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Hide Description Number of participants who experienced AEs leading to discontinuation of study therapy
Time Frame From first dose to 30 days following the last dose (approximately 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description:
Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
Overall Number of Participants Analyzed 239
Measure Type: Count of Participants
Unit of Measure: Participants
42
  17.6%
10.Secondary Outcome
Title Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs)
Hide Description Number of participants who experienced IMAEs. IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Time Frame From first dose to 30 days following the last dose (approximately 25 months)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants Experiencing Select Adverse Events
Hide Description Number of participants who experienced Select Adverse Events. Select Adverse Events categories include: any select AEs, drug-related select AEs, serious select AEs, drug related serious select AEs, any select AEs leading to discontinuation, drug-related select AEs leading to discontinuation
Time Frame From first dose to 30 days following the last dose (approximately 25 months)
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay
Hide Description Number of participants who experienced AEs leading to dose delay. A dose will be considered as delayed if the delay is exceeding 3 days after the intended dose date (i.e., greater than or equal to 4 days from scheduled dosing date)
Time Frame From first dose to 30 days following the last dose (approximately 25 months)
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Number of Participants Experiencing Specific Laboratory Abnormalities
Hide Description Number of participants who experienced specific laboratory abnormalities (measured as change from baseline) in the following disciplines: Hematology, Serum Chemistry, Electrolytes, Abnormal Thyroid Function Test, Abnormal Hepatic Function Test
Time Frame From first dose to 30 days following the last dose (approximately 25 months)
Outcome Measure Data Not Reported
Time Frame All-cause mortality was assessed from first dose to study primary completion date (approximately 36 months). SAEs and Other AEs were assessed from first dose to 100 days following administration of the last dose (approximately 27 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Advanced Malignancies Cohort
Hide Arm/Group Description Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
All-Cause Mortality
Advanced Malignancies Cohort
Affected / at Risk (%)
Total   131/239 (54.81%) 
Hide Serious Adverse Events
Advanced Malignancies Cohort
Affected / at Risk (%)
Total   147/239 (61.51%) 
Blood and lymphatic system disorders   
Anaemia  1  3/239 (1.26%) 
Cardiac disorders   
Acute myocardial infarction  1  1/239 (0.42%) 
Cardiac arrest  1  1/239 (0.42%) 
Cardiac failure congestive  1  1/239 (0.42%) 
Cardio-respiratory arrest  1  1/239 (0.42%) 
Myocardial infarction  1  2/239 (0.84%) 
Supraventricular tachycardia  1  1/239 (0.42%) 
Ventricular tachycardia  1  1/239 (0.42%) 
Endocrine disorders   
Hyperthyroidism  1  1/239 (0.42%) 
Hypophysitis  1  1/239 (0.42%) 
Eye disorders   
Eye pain  1  1/239 (0.42%) 
Eye swelling  1  1/239 (0.42%) 
Gastrointestinal disorders   
Abdominal pain  1  9/239 (3.77%) 
Abdominal pain lower  1  1/239 (0.42%) 
Abdominal pain upper  1  2/239 (0.84%) 
Colitis  1  4/239 (1.67%) 
Diarrhoea  1  5/239 (2.09%) 
Diverticulum intestinal haemorrhagic  1  1/239 (0.42%) 
Dysphagia  1  1/239 (0.42%) 
Gastric haemorrhage  1  1/239 (0.42%) 
Gastrointestinal haemorrhage  1  1/239 (0.42%) 
Gastrointestinal oedema  1  1/239 (0.42%) 
Ileus  1  2/239 (0.84%) 
Inguinal hernia  1  1/239 (0.42%) 
Intestinal obstruction  1  1/239 (0.42%) 
Lower gastrointestinal haemorrhage  1  1/239 (0.42%) 
Nausea  1  4/239 (1.67%) 
Proctalgia  1  1/239 (0.42%) 
Small intestinal obstruction  1  6/239 (2.51%) 
Subileus  1  2/239 (0.84%) 
Vomiting  1  4/239 (1.67%) 
General disorders   
Asthenia  1  2/239 (0.84%) 
Chest pain  1  1/239 (0.42%) 
Fatigue  1  1/239 (0.42%) 
General physical health deterioration  1  4/239 (1.67%) 
Localised oedema  1  1/239 (0.42%) 
Pain  1  1/239 (0.42%) 
Peripheral swelling  1  1/239 (0.42%) 
Pyrexia  1  2/239 (0.84%) 
Sudden death  1  1/239 (0.42%) 
Hepatobiliary disorders   
Cholecystitis  1  3/239 (1.26%) 
Hepatic lesion  1  1/239 (0.42%) 
Immune system disorders   
Anaphylactic reaction  1  1/239 (0.42%) 
Infections and infestations   
Bacteraemia  1  1/239 (0.42%) 
Bronchitis  1  1/239 (0.42%) 
Cellulitis  1  3/239 (1.26%) 
Cholecystitis infective  1  1/239 (0.42%) 
Device related infection  1  1/239 (0.42%) 
Diarrhoea infectious  1  1/239 (0.42%) 
Diverticulitis  1  2/239 (0.84%) 
Enterocolitis infectious  1  1/239 (0.42%) 
Erysipelas  1  1/239 (0.42%) 
Febrile infection  1  1/239 (0.42%) 
Fungaemia  1  1/239 (0.42%) 
Gastroenteritis  1  1/239 (0.42%) 
Herpes zoster  1  2/239 (0.84%) 
Infectious pleural effusion  1  2/239 (0.84%) 
Intervertebral discitis  1  1/239 (0.42%) 
Pelvic abscess  1  1/239 (0.42%) 
Perinephric abscess  1  1/239 (0.42%) 
Pharyngitis streptococcal  1  1/239 (0.42%) 
Pneumonia  1  7/239 (2.93%) 
Renal abscess  1  1/239 (0.42%) 
Sepsis  1  6/239 (2.51%) 
Septic shock  1  1/239 (0.42%) 
Skin infection  1  1/239 (0.42%) 
Urinary tract infection  1  3/239 (1.26%) 
Urosepsis  1  1/239 (0.42%) 
Injury, poisoning and procedural complications   
Humerus fracture  1  1/239 (0.42%) 
Post procedural fever  1  1/239 (0.42%) 
Investigations   
Blood creatinine increased  1  2/239 (0.84%) 
C-reactive protein increased  1  1/239 (0.42%) 
Transaminases increased  1  1/239 (0.42%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/239 (0.42%) 
Dehydration  1  5/239 (2.09%) 
Diabetes mellitus  1  1/239 (0.42%) 
Hypokalaemia  1  1/239 (0.42%) 
Hypomagnesaemia  1  1/239 (0.42%) 
Hypovolaemia  1  1/239 (0.42%) 
Lactic acidosis  1  1/239 (0.42%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/239 (0.84%) 
Back pain  1  2/239 (0.84%) 
Flank pain  1  1/239 (0.42%) 
Musculoskeletal chest pain  1  1/239 (0.42%) 
Myositis  1  1/239 (0.42%) 
Neck pain  1  1/239 (0.42%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenoid cystic carcinoma  1  1/239 (0.42%) 
Brain neoplasm  1  1/239 (0.42%) 
Infected neoplasm  1  1/239 (0.42%) 
Malignant neoplasm of cornea  1  1/239 (0.42%) 
Malignant neoplasm progression  1  58/239 (24.27%) 
Mesothelioma  1  2/239 (0.84%) 
Neoplasm progression  1  2/239 (0.84%) 
Penile cancer  1  1/239 (0.42%) 
Squamous cell carcinoma  1  1/239 (0.42%) 
Transitional cell carcinoma  1  1/239 (0.42%) 
Tumour haemorrhage  1  1/239 (0.42%) 
Tumour pain  1  4/239 (1.67%) 
Nervous system disorders   
Brain oedema  1  1/239 (0.42%) 
Cerebellar infarction  1  1/239 (0.42%) 
Cerebral infarction  1  1/239 (0.42%) 
Cerebrovascular accident  1  1/239 (0.42%) 
Facial paralysis  1  1/239 (0.42%) 
Headache  1  1/239 (0.42%) 
Intracranial mass  1  1/239 (0.42%) 
Neuritis cranial  1  1/239 (0.42%) 
Spinal cord compression  1  1/239 (0.42%) 
Psychiatric disorders   
Delirium  1  1/239 (0.42%) 
Mental status changes  1  1/239 (0.42%) 
Renal and urinary disorders   
Acute kidney injury  1  4/239 (1.67%) 
Chronic kidney disease  1  1/239 (0.42%) 
Haematuria  1  1/239 (0.42%) 
Hydronephrosis  1  1/239 (0.42%) 
Renal failure  1  2/239 (0.84%) 
Urinary tract obstruction  1  2/239 (0.84%) 
Reproductive system and breast disorders   
Vaginal haemorrhage  1  2/239 (0.84%) 
Vulvovaginal pain  1  1/239 (0.42%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  3/239 (1.26%) 
Bronchostenosis  1  1/239 (0.42%) 
Dyspnoea  1  5/239 (2.09%) 
Hypoxia  1  1/239 (0.42%) 
Laryngeal haemorrhage  1  1/239 (0.42%) 
Pleural effusion  1  4/239 (1.67%) 
Pneumothorax  1  1/239 (0.42%) 
Pulmonary embolism  1  1/239 (0.42%) 
Pulmonary hypertension  1  1/239 (0.42%) 
Respiratory failure  1  1/239 (0.42%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/239 (0.42%) 
Vascular disorders   
Embolism  1  1/239 (0.42%) 
Venous stenosis  1  1/239 (0.42%) 
1
Term from vocabulary, 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Advanced Malignancies Cohort
Affected / at Risk (%)
Total   215/239 (89.96%) 
Blood and lymphatic system disorders   
Anaemia  1  41/239 (17.15%) 
Endocrine disorders   
Hypothyroidism  1  21/239 (8.79%) 
Gastrointestinal disorders   
Abdominal pain  1  33/239 (13.81%) 
Abdominal pain upper  1  12/239 (5.02%) 
Constipation  1  50/239 (20.92%) 
Diarrhoea  1  52/239 (21.76%) 
Dry mouth  1  14/239 (5.86%) 
Nausea  1  53/239 (22.18%) 
Vomiting  1  32/239 (13.39%) 
General disorders   
Chills  1  14/239 (5.86%) 
Fatigue  1  90/239 (37.66%) 
Oedema peripheral  1  23/239 (9.62%) 
Pyrexia  1  24/239 (10.04%) 
Infections and infestations   
Upper respiratory tract infection  1  15/239 (6.28%) 
Urinary tract infection  1  21/239 (8.79%) 
Investigations   
Alanine aminotransferase increased  1  16/239 (6.69%) 
Aspartate aminotransferase increased  1  18/239 (7.53%) 
Blood alkaline phosphatase increased  1  12/239 (5.02%) 
Blood creatinine increased  1  15/239 (6.28%) 
Weight decreased  1  22/239 (9.21%) 
Metabolism and nutrition disorders   
Decreased appetite  1  37/239 (15.48%) 
Dehydration  1  23/239 (9.62%) 
Hypokalaemia  1  18/239 (7.53%) 
Hyponatraemia  1  14/239 (5.86%) 
Hypophosphataemia  1  12/239 (5.02%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  28/239 (11.72%) 
Back pain  1  27/239 (11.30%) 
Pain in extremity  1  15/239 (6.28%) 
Nervous system disorders   
Dizziness  1  15/239 (6.28%) 
Headache  1  19/239 (7.95%) 
Psychiatric disorders   
Anxiety  1  13/239 (5.44%) 
Insomnia  1  17/239 (7.11%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  43/239 (17.99%) 
Dyspnoea  1  44/239 (18.41%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  12/239 (5.02%) 
Pruritus  1  26/239 (10.88%) 
Rash  1  20/239 (8.37%) 
Vascular disorders   
Hypertension  1  16/239 (6.69%) 
1
Term from vocabulary, 23.0
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please email
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02832167    
Other Study ID Numbers: CA209-627
2016-000461-23 ( EudraCT Number )
First Submitted: July 8, 2016
First Posted: July 14, 2016
Results First Submitted: October 20, 2020
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020