Trial Outcomes & Findings for Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-small Cell Lung Cancer (NCT NCT02846792)

NCT ID: NCT02846792

Last Updated: 2019-03-04

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2019-03-04

Participant Flow

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.

Five patients were consented and treated.

Participant milestones

Measure	Treatment (Plinabulin, Nivolumab) 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 Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment (Plinabulin, Nivolumab) n=5 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months

Population: Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months

Population: Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months

Population: Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.

Will be summarized using descriptive statistics (mean, standard deviation, median, minimum and maximum values).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time between receipt of first study drug until death date or last known alive date, assessed up to 16 months

Population: Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.

Will be summarized using descriptive statistics (mean, standard deviation, median, minimum and maximum values).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Treatment (Plinabulin, Nivolumab) n=5 Participants 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
Toxicity Rates	4 Participants

SECONDARY outcome

Timeframe: Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months

Population: Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.

Assessed using Response Evaluation Criteria in Solid Tumors version 1.1.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Plinabulin, Nivolumab)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Plinabulin, Nivolumab) n=5 participants at risk 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
Cardiac disorders Atrioventricular block	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Infections and infestations Lung infection	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.

Other adverse events

Measure	Treatment (Plinabulin, Nivolumab) n=5 participants at risk 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
General disorders Infusion related reaction	40.0% 2/5 • Number of events 3 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Gastrointestinal disorders Mucositis oral	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Infections and infestations Lung infection	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	20.0% 1/5 • Number of events 2 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Vascular disorders Hypertension	20.0% 1/5 • Number of events 1 • 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. Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.

Additional Information

Research Manager

University of Washington

Phone: 206-606-7445

Email: smasters@seattlecca.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place