Cypress 2: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This is an open-label, multi-center, randomized, Phase 2 study designed to compare the efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with low tumor expression of PD-L1 (0-49%).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pegilodecakin+Nivolumab Participants received Pegilodecakin subcutaneously at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W). |
Biological: Pegilodecakin
Pegilodecakin plus Nivolumab
Other Names:
Drug: Nivolumab
Nivolumab Alone
|
Active Comparator: Nivolumab Participants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W). |
Drug: Nivolumab
Nivolumab Alone
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] [From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)]
Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Secondary Outcome Measures
- Overall Survival (OS) [From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)]
OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
- Progression Free Survival (PFS) [From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized)]
PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
- Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization)]
Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
- Duration of Response [From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)]
Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants must have histologically or cytologically confirmed Wild Type NSCLC that is stage IV / metastatic or recurrent
-
Participants must have received at least one prior systemic therapy that was not an anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the disease
-
Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-
Participants with measurable disease by spiral computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1 criteria
-
Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization
Exclusion Criteria:
-
Participants with active central nervous system (CNS) metastases or carcinomatous meningitis
-
Participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV)
-
Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy (other than alopecia and fatigue) prior to randomization
-
Participants that have received nivolumab
-
Participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
-
Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
-
Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2, anti-CD-137, and/or anti CTLA-4 antibodies
-
Participants receiving any investigational agent within 28 days of first administration of trial treatment
-
Pregnant or lactating women
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Arizona Oncology Associates, P.C. | Tempe | Arizona | United States | 85284 |
2 | Beverly Hills Cancer Center | Beverly Hills | California | United States | 90211 |
3 | Glendale Adventist Medical Center | Los Angeles | California | United States | 90017 |
4 | Redwood Regional Oncology Center | Santa Rosa | California | United States | 95403 |
5 | The Oncology Institute of Hope and Innovation | Whittier | California | United States | 90602 |
6 | Rocky Mountain Cancer Center | Lone Tree | Colorado | United States | 80124 |
7 | John B. Amos Cancer Center | Columbus | Georgia | United States | 31904 |
8 | Covenant Clinic | Waterloo | Iowa | United States | 50702 |
9 | Baptist Health Medical Group | Lexington | Kentucky | United States | 40503 |
10 | MedStar Health Research Institute | Baltimore | Maryland | United States | 21237 |
11 | Maryland Oncology Hematology, P.A. | Columbia | Maryland | United States | 21044 |
12 | Frederick Memorial Hospital | Frederick | Maryland | United States | 21701 |
13 | Sparrow Health System | Lansing | Michigan | United States | 48912 |
14 | Hattiesburg Clinic | Hattiesburg | Mississippi | United States | 39401 |
15 | The Valley Hospital - Luckow Pavilion | Westwood | New Jersey | United States | 07675 |
16 | Broome Oncology LLC | Johnson City | New York | United States | 13790 |
17 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
18 | Clinical Research Alliance, Inc. | New Hyde Park | New York | United States | 11042 |
19 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
20 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
21 | Christ Hospital | Cincinnati | Ohio | United States | 45219 |
22 | University of Toledo Medical Center | Toledo | Ohio | United States | 43614-2598 |
23 | Charleston Hematology Oncology Associates | Charleston | South Carolina | United States | 29414 |
24 | Mamie McFaddin Ward Cancer Center | Beaumont | Texas | United States | 77702 |
25 | Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | United States | 75231 |
26 | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
27 | Texas Oncology-Memorial City | Houston | Texas | United States | 77024 |
28 | Millennium Oncology | Houston | Texas | United States | 77090 |
29 | Joe Arrington Cancer Center | Lubbock | Texas | United States | 79410 |
30 | Texas Oncology - Midland Allison Cancer Center | Midland | Texas | United States | 79701 |
31 | US Oncology | The Woodlands | Texas | United States | 77380 |
32 | Texas Oncology - Tyler | Tyler | Texas | United States | 75702 |
33 | Fairfax Northern Virginia Hematology Oncology, PC | Fairfax | Virginia | United States | 22031 |
34 | Oncology and Hematology Associates of Southwest Virginia Inc | Roanoke | Virginia | United States | 24014 |
35 | MultiCare Regional Cancer Center - Auburn | Tacoma | Washington | United States | 98002 |
Sponsors and Collaborators
- Eli Lilly and Company
- ARMO BioSciences
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
More Information
Publications
None provided.- 17161
- J1L-AM-JZGD
- AM0010-202
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Completer's included participants who had progression free survival events (Progressive Disease (PD) or death). |
Arm/Group Title | Pegilodecakin+Nivolumab | Nivolumab |
---|---|---|
Arm/Group Description | Participants received Pegilodecakin subcutaneously at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W). | Participants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W). |
Period Title: Overall Study | ||
STARTED | 27 | 25 |
Received at Least 1 Dose of Study Drug | 27 | 24 |
COMPLETED | 21 | 13 |
NOT COMPLETED | 6 | 12 |
Baseline Characteristics
Arm/Group Title | Pegilodecakin + Nivolumab | Nivolumab | Total |
---|---|---|---|
Arm/Group Description | Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W, or 480 mg Q4W. | Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W, or 480 mg Q4W. | Total of all reporting groups |
Overall Participants | 27 | 25 | 52 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
68.4
(8.2)
|
65.9
(10.4)
|
67.2
(9.3)
|
Sex: Female, Male (Count of Participants) | |||
Female |
10
37%
|
11
44%
|
21
40.4%
|
Male |
17
63%
|
14
56%
|
31
59.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
0
0%
|
2
8%
|
2
3.8%
|
Not Hispanic or Latino |
24
88.9%
|
20
80%
|
44
84.6%
|
Unknown or Not Reported |
3
11.1%
|
3
12%
|
6
11.5%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
1
3.7%
|
0
0%
|
1
1.9%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
1
3.7%
|
3
12%
|
4
7.7%
|
White |
23
85.2%
|
20
80%
|
43
82.7%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
2
7.4%
|
2
8%
|
4
7.7%
|
Region of Enrollment (Count of Participants) | |||
United States |
27
100%
|
25
100%
|
52
100%
|
Outcome Measures
Title | Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] |
---|---|
Description | Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. |
Time Frame | From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Pegilodecakin + Nivolumab | Nivolumab |
---|---|---|
Arm/Group Description | Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. | Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. |
Measure Participants | 27 | 25 |
Number (95% Confidence Interval) [Percentage of participants] |
14.8
54.8%
|
12.0
48%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + Nivolumab, Nivolumab |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% 0.3 to 5.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Odds Ratio stratified based on tumor histology at randomization (interactive web response system (IWRS)), smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method. |
Title | Overall Survival (OS) |
---|---|
Description | OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive. |
Time Frame | From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. Participants censored: Pegilodecakin + Nivolumab = 6 and Nivolumab = 5. |
Arm/Group Title | Pegilodecakin + Nivolumab | Nivolumab |
---|---|---|
Arm/Group Description | Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. | Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. |
Measure Participants | 27 | 25 |
Median (95% Confidence Interval) [Months] |
1.87
|
1.94
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + Nivolumab, Nivolumab |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.006 | |
Confidence Interval |
(2-Sided) 95% 0.519 to 1.951 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (interactive web response system (IWRS)) and smoking status (IWRS). |
Title | Progression Free Survival (PFS) |
---|---|
Description | PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment. |
Time Frame | From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. Participants censored: Pegilodecakin + Nivolumab = 12 and Nivolumab = 16. |
Arm/Group Title | Pegilodecakin + Nivolumab | Nivolumab |
---|---|---|
Arm/Group Description | Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. | Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. |
Measure Participants | 27 | 25 |
Median (95% Confidence Interval) [Months] |
6.70
|
10.74
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + Nivolumab, Nivolumab |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.871 | |
Confidence Interval |
(2-Sided) 95% 0.772 to 4.532 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS). |
Title | Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) |
---|---|
Description | Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. |
Time Frame | From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Pegilodecakin + Nivolumab | Nivolumab |
---|---|---|
Arm/Group Description | Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. | Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. |
Measure Participants | 27 | 25 |
Number (95% Confidence Interval) [Percentage of participants] |
37.0
137%
|
28.0
112%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + Nivolumab, Nivolumab |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% 0.4 to 4.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Odds Ratio stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method. |
Title | Duration of Response |
---|---|
Description | Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment. |
Time Frame | From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least one dose of study drug and had CR or PR responses. Participants censored: Pegilodecakin + Nivolumab = 3 and Nivolumab = 1. |
Arm/Group Title | Pegilodecakin + Nivolumab | Nivolumab |
---|---|---|
Arm/Group Description | Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. | Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. |
Measure Participants | 4 | 3 |
Median (95% Confidence Interval) [Months] |
NA
|
3.06
|
Adverse Events
Time Frame | Up to 23 Months | |||
---|---|---|---|---|
Adverse Event Reporting Description | All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. | |||
Arm/Group Title | Pegilodecakin + Nivolumab | Nivolumab | ||
Arm/Group Description | Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. | Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W. | ||
All Cause Mortality |
||||
Pegilodecakin + Nivolumab | Nivolumab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 15/27 (55.6%) | 12/24 (50%) | ||
Serious Adverse Events |
||||
Pegilodecakin + Nivolumab | Nivolumab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 13/27 (48.1%) | 9/24 (37.5%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 4/27 (14.8%) | 4 | 1/24 (4.2%) | 1 |
Haemolysis | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Thrombocytopenia | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Cardiac disorders | ||||
Cardiac arrest | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Cardio-respiratory arrest | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Cardiomyopathy | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Tachycardia | 0/27 (0%) | 0 | 1/24 (4.2%) | 2 |
Gastrointestinal disorders | ||||
Bezoar | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
General disorders | ||||
Asthenia | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Pyrexia | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Infections and infestations | ||||
Pleural infection | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Pneumonia | 1/27 (3.7%) | 1 | 3/24 (12.5%) | 3 |
Rhinovirus infection | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Sepsis | 1/27 (3.7%) | 1 | 1/24 (4.2%) | 1 |
Streptococcal bacteraemia | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Injury, poisoning and procedural complications | ||||
Fall | 2/27 (7.4%) | 2 | 0/24 (0%) | 0 |
Spinal fracture | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Dehydration | 1/27 (3.7%) | 1 | 1/24 (4.2%) | 1 |
Hyperkalaemia | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Bone neoplasm | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Malignant pleural effusion | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Tumour pain | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Nervous system disorders | ||||
Metabolic encephalopathy | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Syncope | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Psychiatric disorders | ||||
Mental status changes | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Renal and urinary disorders | ||||
Acute kidney injury | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Acute respiratory failure | 2/27 (7.4%) | 2 | 0/24 (0%) | 0 |
Bronchospasm | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Dyspnoea | 1/27 (3.7%) | 1 | 2/24 (8.3%) | 4 |
Hypoxia | 0/27 (0%) | 0 | 2/24 (8.3%) | 2 |
Pleural effusion | 0/27 (0%) | 0 | 1/24 (4.2%) | 2 |
Respiratory failure | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Vascular disorders | ||||
Hypotension | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 |
Superior vena cava syndrome | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Pegilodecakin + Nivolumab | Nivolumab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 27/27 (100%) | 22/24 (91.7%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 14/27 (51.9%) | 37 | 5/24 (20.8%) | 24 |
Thrombocytopenia | 5/27 (18.5%) | 15 | 2/24 (8.3%) | 3 |
Cardiac disorders | ||||
Atrial fibrillation | 1/27 (3.7%) | 1 | 4/24 (16.7%) | 5 |
Ear and labyrinth disorders | ||||
Ear discomfort | 0/27 (0%) | 0 | 2/24 (8.3%) | 2 |
Endocrine disorders | ||||
Hypothyroidism | 3/27 (11.1%) | 3 | 3/24 (12.5%) | 3 |
Gastrointestinal disorders | ||||
Abdominal pain | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 2 |
Constipation | 7/27 (25.9%) | 8 | 5/24 (20.8%) | 5 |
Diarrhoea | 2/27 (7.4%) | 3 | 3/24 (12.5%) | 4 |
Dyspepsia | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 |
Gastrooesophageal reflux disease | 0/27 (0%) | 0 | 2/24 (8.3%) | 2 |
Nausea | 4/27 (14.8%) | 5 | 4/24 (16.7%) | 7 |
Vomiting | 6/27 (22.2%) | 6 | 2/24 (8.3%) | 2 |
General disorders | ||||
Asthenia | 4/27 (14.8%) | 9 | 1/24 (4.2%) | 1 |
Chills | 3/27 (11.1%) | 3 | 0/24 (0%) | 0 |
Fatigue | 17/27 (63%) | 35 | 10/24 (41.7%) | 18 |
Gait disturbance | 3/27 (11.1%) | 3 | 0/24 (0%) | 0 |
Influenza like illness | 2/27 (7.4%) | 2 | 0/24 (0%) | 0 |
Injection site rash | 5/27 (18.5%) | 5 | 0/24 (0%) | 0 |
Oedema peripheral | 4/27 (14.8%) | 11 | 3/24 (12.5%) | 3 |
Pain | 1/27 (3.7%) | 1 | 2/24 (8.3%) | 2 |
Pyrexia | 8/27 (29.6%) | 14 | 4/24 (16.7%) | 4 |
Infections and infestations | ||||
Pneumonia | 2/27 (7.4%) | 3 | 2/24 (8.3%) | 2 |
Upper respiratory tract infection | 1/27 (3.7%) | 2 | 2/24 (8.3%) | 3 |
Urinary tract infection | 2/27 (7.4%) | 2 | 3/24 (12.5%) | 5 |
Vaginal infection | 0/10 (0%) | 0 | 1/11 (9.1%) | 1 |
Injury, poisoning and procedural complications | ||||
Fall | 1/27 (3.7%) | 1 | 3/24 (12.5%) | 5 |
Investigations | ||||
Alanine aminotransferase increased | 1/27 (3.7%) | 1 | 2/24 (8.3%) | 4 |
Aspartate aminotransferase increased | 2/27 (7.4%) | 2 | 3/24 (12.5%) | 6 |
Blood alkaline phosphatase increased | 3/27 (11.1%) | 3 | 2/24 (8.3%) | 4 |
Blood bilirubin increased | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 |
Blood creatinine increased | 2/27 (7.4%) | 3 | 0/24 (0%) | 0 |
Blood thyroid stimulating hormone increased | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 |
Platelet count decreased | 4/27 (14.8%) | 5 | 0/24 (0%) | 0 |
Troponin increased | 2/27 (7.4%) | 2 | 0/24 (0%) | 0 |
Weight decreased | 5/27 (18.5%) | 6 | 5/24 (20.8%) | 6 |
Metabolism and nutrition disorders | ||||
Decreased appetite | 11/27 (40.7%) | 12 | 7/24 (29.2%) | 9 |
Dehydration | 6/27 (22.2%) | 8 | 3/24 (12.5%) | 5 |
Hyperglycaemia | 2/27 (7.4%) | 8 | 1/24 (4.2%) | 2 |
Hypoalbuminaemia | 2/27 (7.4%) | 4 | 0/24 (0%) | 0 |
Hypocalcaemia | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 |
Hypokalaemia | 4/27 (14.8%) | 7 | 4/24 (16.7%) | 7 |
Hypomagnesaemia | 2/27 (7.4%) | 2 | 3/24 (12.5%) | 4 |
Hypophosphataemia | 0/27 (0%) | 0 | 2/24 (8.3%) | 3 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 3/27 (11.1%) | 3 | 5/24 (20.8%) | 7 |
Back pain | 3/27 (11.1%) | 3 | 2/24 (8.3%) | 2 |
Groin pain | 2/27 (7.4%) | 4 | 0/24 (0%) | 0 |
Muscular weakness | 1/27 (3.7%) | 1 | 3/24 (12.5%) | 3 |
Musculoskeletal chest pain | 1/27 (3.7%) | 1 | 3/24 (12.5%) | 5 |
Musculoskeletal pain | 2/27 (7.4%) | 2 | 0/24 (0%) | 0 |
Pain in extremity | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 |
Nervous system disorders | ||||
Dizziness | 7/27 (25.9%) | 10 | 4/24 (16.7%) | 4 |
Dysgeusia | 2/27 (7.4%) | 3 | 0/24 (0%) | 0 |
Headache | 2/27 (7.4%) | 3 | 2/24 (8.3%) | 2 |
Psychiatric disorders | ||||
Anxiety | 3/27 (11.1%) | 4 | 2/24 (8.3%) | 2 |
Depression | 0/27 (0%) | 0 | 3/24 (12.5%) | 3 |
Insomnia | 4/27 (14.8%) | 4 | 3/24 (12.5%) | 3 |
Renal and urinary disorders | ||||
Pollakiuria | 0/27 (0%) | 0 | 3/24 (12.5%) | 3 |
Reproductive system and breast disorders | ||||
Erectile dysfunction | 1/17 (5.9%) | 1 | 0/14 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Chronic obstructive pulmonary disease | 2/27 (7.4%) | 2 | 3/24 (12.5%) | 3 |
Cough | 8/27 (29.6%) | 9 | 4/24 (16.7%) | 5 |
Dysphonia | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 |
Dyspnoea | 14/27 (51.9%) | 18 | 10/24 (41.7%) | 16 |
Haemoptysis | 2/27 (7.4%) | 3 | 1/24 (4.2%) | 1 |
Hypoxia | 2/27 (7.4%) | 2 | 3/24 (12.5%) | 4 |
Nasal congestion | 0/27 (0%) | 0 | 2/24 (8.3%) | 2 |
Oropharyngeal pain | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 |
Pleural effusion | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 |
Wheezing | 1/27 (3.7%) | 1 | 2/24 (8.3%) | 3 |
Skin and subcutaneous tissue disorders | ||||
Alopecia | 0/27 (0%) | 0 | 2/24 (8.3%) | 2 |
Decubitus ulcer | 2/27 (7.4%) | 3 | 0/24 (0%) | 0 |
Pruritus | 4/27 (14.8%) | 7 | 5/24 (20.8%) | 6 |
Rash | 5/27 (18.5%) | 5 | 1/24 (4.2%) | 2 |
Rash maculo-papular | 2/27 (7.4%) | 3 | 1/24 (4.2%) | 1 |
Rash pruritic | 2/27 (7.4%) | 3 | 0/24 (0%) | 0 |
Vascular disorders | ||||
Hypotension | 7/27 (25.9%) | 9 | 6/24 (25%) | 7 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-545-5979 |
ClinicalTrials.gov@lilly.com |
- 17161
- J1L-AM-JZGD
- AM0010-202