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Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02846792
Recruitment Status : Terminated (Immunotherapy approved for NSCLC in the first line setting)
First Posted : July 27, 2016
Results First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions ALK Gene Translocation
EGFR Activating Mutation
Recurrent Non-Small Cell Lung Carcinoma
ROS1 Gene Translocation
Stage IIIB Non-Small Cell Lung Cancer AJCC v7
Stage IV Non-Small Cell Lung Cancer AJCC v7
Interventions Biological: Nivolumab
Drug: Plinabulin
Enrollment 5
Recruitment Details Seattle Cancer Care Alliance/University of Washington Phase I/II trial open label study enrolled patients at a single site between June 2017 and July 2018.
Pre-assignment Details Five patients were consented and treated.
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
Baseline participant measures are based on total eligible, consented and treated patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  20.0%
>=65 years
4
  80.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
70
(59 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
5
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Maximum Tolerated Dose of Plinabulin and Nivolumab (Phase I)
Hide Description Defined as no more than 1 of 6 patients experiencing a dose limiting toxicity, graded according to the National Cancer Institute Common Toxicity Criteria version 4.0.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description:

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Overall Response Rate (Phase II)
Hide Description Defined as the sum of complete and partial responses for more than 8 weeks according to Response Evaluation Criteria in Solid Tumors version 1.1.
Time Frame Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description:

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Disease Control Rate
Hide Description Defined as the proportion of patients with complete response, partial response, and stable disease for more than 8 weeks according to Response Evaluation Criteria in Solid Tumors version 1.1.
Time Frame Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description:

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Response
Hide Description Will be summarized using descriptive statistics (mean, standard deviation, median, minimum and maximum values).
Time Frame Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description:

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description Will be summarized using descriptive statistics (mean, standard deviation, median, minimum and maximum values).
Time Frame Time between receipt of first study drug until death date or last known alive date, assessed up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description:

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Toxicity Rates
Hide Description Overall Percentage and number of patients experiencing grade 3 or higher severity of adverse events, graded using the National Cancer Institute Common Toxicity Criteria version 4.0.
Time Frame Adverse events collected from the time patient received the first dose of study therapy through 28 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 28 days post therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description:

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
4
  80.0%
7.Secondary Outcome
Title Progression Free Survival
Hide Description Assessed using Response Evaluation Criteria in Solid Tumors version 1.1.
Time Frame Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description:

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events collected from the time patient received the first dose of study therapy through 28 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 28 days post therapy.
Adverse Event Reporting Description Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
 
Arm/Group Title Treatment (Plinabulin, Nivolumab)
Hide Arm/Group Description

Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nivolumab: Given IV

Plinabulin: Given IV

All-Cause Mortality
Treatment (Plinabulin, Nivolumab)
Affected / at Risk (%)
Total   0/5 (0.00%)    
Hide Serious Adverse Events
Treatment (Plinabulin, Nivolumab)
Affected / at Risk (%) # Events
Total   4/5 (80.00%)    
Cardiac disorders   
Atrioventricular block * 1  1/5 (20.00%)  1
Infections and infestations   
Lung infection * 1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorder - Other * 1 [1]  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders - Other * 1 [2]  1/5 (20.00%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[1]
Prophylactic surgical stabilization of the left femoral head and left proximal tibia due to bone metastases
[2]
Progressive disease
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Plinabulin, Nivolumab)
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Gastrointestinal disorders   
Mucositis oral * 1  1/5 (20.00%)  1
Nausea * 1  1/5 (20.00%)  1
General disorders   
Infusion related reaction * 1  2/5 (40.00%)  3
Infections and infestations   
Lung infection * 1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorder - Other * 1 [1]  1/5 (20.00%)  2
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/5 (20.00%)  1
Vascular disorders   
Hypertension * 1  1/5 (20.00%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[1]
Radiation therapy to painful bone metastases
Study terminated (stopped prematurely), due to immunotherapy approved for NSCLC in the first line setting. Participant flow, Baseline Characteristics and Adverse Events recorded for 5 patients treated on study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Research Manager
Organization: University of Washington
Phone: 206-606-7445
EMail: smasters@seattlecca.org
Layout table for additonal information
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02846792    
Other Study ID Numbers: 9602
NCI-2016-01009 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9602 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2016
First Posted: July 27, 2016
Results First Submitted: January 22, 2019
Results First Posted: March 4, 2019
Last Update Posted: March 4, 2019