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Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens

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ClinicalTrials.gov Identifier: NCT01721759
Recruitment Status : Active, not recruiting
First Posted : November 6, 2012
Results First Posted : October 22, 2015
Last Update Posted : March 25, 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 Squamous Cell Non-small Cell Lung Cancer
Intervention Drug: Nivolumab
Enrollment 140
Recruitment Details  
Pre-assignment Details A total of 140 patients were enrolled, and 117 received treatment. Of those 23 patients who were enrolled but did not receive study drug, 20 were eliminated because they no longer met study criteria, 2 died, and 1 was lost to follow-up.
Arm/Group Title Nivolumab, 3 mg/kg
Hide Arm/Group Description Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
Period Title: Overall Study
Started 117
Completed 15 [1]
Not Completed 102
Reason Not Completed
Disease progression             78
Study drug toxicity             14
Adverse event unrelated to study drug             9
Withdrawal by Subject             1
[1]
Completed=continuing to receive treatment
Arm/Group Title Nivolumab, 3 mg/kg
Hide Arm/Group Description Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
Overall Number of Baseline Participants 117
Hide Baseline Analysis Population Description
Participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants
64.1  (9.11)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants
Younger than 65 years 58
At least 65 years and younger than 75 years 43
75 years and older 16
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants
Female
32
  27.4%
Male
85
  72.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
69
  59.0%
Unknown or Not Reported
48
  41.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants
White 99
Black or African American 11
American Indian or Alaska Native 0
Asian 2
Native Hawaiian or other Pacific Islander 0
Other 5
Disease stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants
Stage IIIB 20
Stage IV 97
[1]
Measure Description: Non-Small Cell Lung Cancer is categorized in 4 Stages (I-IV). I: Cancer located only in lungs and has not spread to any lymph nodes. II: Cancer in the lung and nearby lymph nodes. III: Cancer in the lung and lymph nodes in the middle of the chest. Stage III has two subtypes, IIIA (cancer has spread only to lymph nodes on the same side of the chest where the cancer started) and IIIB (cancer has spread to the lymph nodes on the opposite side of the chest, or above the collar bone). IV: Cancer has spread to both lungs, to fluid in the area around the lungs, or to another part of the body
Cell type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants
Squamous cell carcinoma 117
Other 0
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants
0 26
1 91
2 0
3 0
4 0
[1]
Measure Description: ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
Central nervous system metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants
Yes 2
No 115
1.Primary Outcome
Title Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)
Hide Description

ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.

Participants were evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.

Time Frame Day 1 of treatment to approximately 19 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug
Arm/Group Title Nivolumab, 3 mg/kg
Hide Arm/Group Description:
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
Overall Number of Participants Analyzed 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
14.5
(8.7 to 22.2)
2.Primary Outcome
Title Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)
Hide Description

ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.

Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.

Time Frame Day 1 of treatment to approximately 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug
Arm/Group Title Nivolumab, 3 mg/kg
Hide Arm/Group Description:
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
Overall Number of Participants Analyzed 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
12
(6.7 to 19.3)
3.Secondary Outcome
Title Objective Response Rate (ORR) as Assessed by Investigator
Hide Description

ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment.

Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Best overall response, ORR, duration of response, and time to response as assessed by investigator were summarized using RECIST v1.1, to confirm response.

Time Frame Day 1 of treatment to approximately 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug
Arm/Group Title Nivolumab, 3 mg/kg
Hide Arm/Group Description:
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
Overall Number of Participants Analyzed 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
12.8
(7.4 to 20.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NivolumAB, 3 mg/kg
Hide Arm/Group Description Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
All-Cause Mortality
NivolumAB, 3 mg/kg
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
NivolumAB, 3 mg/kg
Affected / at Risk (%)
Total   65/117 (55.56%) 
Cardiac disorders   
Cardio-respiratory arrest  1  1/117 (0.85%) 
Atrial fibrillation  1  1/117 (0.85%) 
Endocrine disorders   
Adrenal insufficiency  1  1/117 (0.85%) 
Gastrointestinal disorders   
Abdominal pain  1  2/117 (1.71%) 
Gastrointestinal haemorrhage  1  1/117 (0.85%) 
Dysphagia  1  1/117 (0.85%) 
Large intestinal ulcer  1  1/117 (0.85%) 
Vomiting  1  1/117 (0.85%) 
Diarrhoea  1  1/117 (0.85%) 
Haematemesis  1  1/117 (0.85%) 
General disorders   
Disease progression  1  1/117 (0.85%) 
Pain  1  3/117 (2.56%) 
Performance status decreased  1  1/117 (0.85%) 
Immune system disorders   
Anaphylactic reaction  1  1/117 (0.85%) 
Hypersensitivity  1  1/117 (0.85%) 
Infections and infestations   
Diverticulitis  1  1/117 (0.85%) 
Wound infection  1  1/117 (0.85%) 
Cellulitis  1  1/117 (0.85%) 
Septic shock  1  1/117 (0.85%) 
Bronchitis  1  1/117 (0.85%) 
Pulmonary sepsis  1  1/117 (0.85%) 
Herpes zoster  1  1/117 (0.85%) 
Lung infection  1  1/117 (0.85%) 
Pneumonia  1  6/117 (5.13%) 
Injury, poisoning and procedural complications   
Spinal fracture  1  1/117 (0.85%) 
Toxicity to various agents  1  1/117 (0.85%) 
Investigations   
C-reactive protein increased  1  1/117 (0.85%) 
Metabolism and nutrition disorders   
Hypercalcaemia  1  5/117 (4.27%) 
Decreased appetite  1  1/117 (0.85%) 
Hyponatraemia  1  1/117 (0.85%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  1/117 (0.85%) 
Musculoskeletal chest pain  1  2/117 (1.71%) 
Pathological fracture  1  1/117 (0.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour pain  1  1/117 (0.85%) 
Skin cancer  1  1/117 (0.85%) 
Malignant neoplasm progression  1  7/117 (5.98%) 
Nervous system disorders   
Motor dysfunction  1  1/117 (0.85%) 
Peripheral nerve paresis  1  1/117 (0.85%) 
Cognitive disorder  1  1/117 (0.85%) 
Convulsion  1  1/117 (0.85%) 
Headache  1  1/117 (0.85%) 
Psychiatric disorders   
Confusional state  1  2/117 (1.71%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  8/117 (6.84%) 
Laryngeal haemorrhage  1  1/117 (0.85%) 
Pulmonary haemorrhage  1  2/117 (1.71%) 
Pulmonary embolism  1  1/117 (0.85%) 
Pleural effusion  1  1/117 (0.85%) 
Acute respiratory failure  1  1/117 (0.85%) 
Bronchospasm  1  1/117 (0.85%) 
Chronic obstructive pulmonary disease  1  3/117 (2.56%) 
Pneumonitis  1  4/117 (3.42%) 
Haemoptysis  1  3/117 (2.56%) 
Tachypnoea  1  1/117 (0.85%) 
Hypoxia  1  1/117 (0.85%) 
Vascular disorders   
Superior vena cava syndrome  1  2/117 (1.71%) 
Aortic aneurysm rupture  1  1/117 (0.85%) 
Embolism  1  1/117 (0.85%) 
Deep vein thrombosis  1  1/117 (0.85%) 
Hypotension  1  1/117 (0.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NivolumAB, 3 mg/kg
Affected / at Risk (%)
Total   109/117 (93.16%) 
Blood and lymphatic system disorders   
Anaemia  1  18/117 (15.38%) 
Gastrointestinal disorders   
Abdominal pain  1  12/117 (10.26%) 
Dry mouth  1  8/117 (6.84%) 
Constipation  1  27/117 (23.08%) 
Nausea  1  33/117 (28.21%) 
Vomiting  1  21/117 (17.95%) 
Diarrhoea  1  18/117 (15.38%) 
General disorders   
Fatigue  1  57/117 (48.72%) 
Mucosal inflammation  1  7/117 (5.98%) 
Pain  1  10/117 (8.55%) 
Chest pain  1  9/117 (7.69%) 
Oedema peripheral  1  14/117 (11.97%) 
Pyrexia  1  17/117 (14.53%) 
Asthenia  1  21/117 (17.95%) 
Infections and infestations   
Bronchitis  1  7/117 (5.98%) 
Investigations   
Weight decreased  1  13/117 (11.11%) 
Blood creatinine increased  1  10/117 (8.55%) 
Metabolism and nutrition disorders   
Hypophosphataemia  1  6/117 (5.13%) 
Hypercalcaemia  1  9/117 (7.69%) 
Decreased appetite  1  39/117 (33.33%) 
Hypomagnesaemia  1  7/117 (5.98%) 
Dehydration  1  8/117 (6.84%) 
Hyponatraemia  1  7/117 (5.98%) 
Hyperglycaemia  1  7/117 (5.98%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  6/117 (5.13%) 
Musculoskeletal chest pain  1  7/117 (5.98%) 
Myalgia  1  11/117 (9.40%) 
Arthralgia  1  13/117 (11.11%) 
Pain in extremity  1  6/117 (5.13%) 
Back pain  1  11/117 (9.40%) 
Nervous system disorders   
Dizziness  1  9/117 (7.69%) 
Headache  1  10/117 (8.55%) 
Neuropathy peripheral  1  8/117 (6.84%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  40/117 (34.19%) 
Cough  1  34/117 (29.06%) 
Haemoptysis  1  6/117 (5.13%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  12/117 (10.26%) 
Rash  1  13/117 (11.11%) 
Vascular disorders   
Hypertension  1  7/117 (5.98%) 
Hypotension  1  8/117 (6.84%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01721759    
Other Study ID Numbers: CA209-063
2012-003965-16 ( EudraCT Number )
First Submitted: November 2, 2012
First Posted: November 6, 2012
Results First Submitted: September 14, 2015
Results First Posted: October 22, 2015
Last Update Posted: March 25, 2020