Trial Outcomes & Findings for Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC (NCT NCT03573947)
NCT ID: NCT03573947
Last Updated: 2025-10-14
Results Overview
Progression-free survival (PFS) will be defined as the time from first dosing date to the date of the first documented tumor progression determined by the investigator using RECIST 1.1 or death, whichever occurs first
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
up to 4 years
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
nivolumab, ipilimumab and paclitaxel
patients will be treated with nivolumab and ipilimumab in combination with weekly paclitaxel days 1 and 8 every 21 days until they experience unacceptable drug-related toxicity, disease progression or 24 months.
The dosing regimen will be: nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and paclitaxel 80 mg/m2 on days 1 and 8 of 1 21 day treatment cycle. Paclitaxel would be stopped after a total of 4-6 cycles of treatment.
Nivolumab: 360 mg intravenously every 3 weeks
Ipilimumab: 1 mg/kg intravenously over 30 minutes
Paclitaxel: 80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC
Baseline characteristics by cohort
| Measure |
nivolumab, ipilimumab and paclitaxel
n=46 Participants
patients will be treated with nivolumab and ipilimumab in combination with weekly paclitaxel days 1 and 8 every 21 days until they experience unacceptable drug-related toxicity, disease progression or 24 months.
The dosing regimen will be: nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and paclitaxel 80 mg/m2 on days 1 and 8 of 1 21 day treatment cycle. Paclitaxel would be stopped after a total of 4-6 cycles of treatment.
Nivolumab: 360 mg intravenously every 3 weeks
Ipilimumab: 1 mg/kg intravenously over 30 minutes
Paclitaxel: 80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 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
|
46 Participants
n=5 Participants
|
|
Smoking status
Current
|
9 Participants
n=5 Participants
|
|
Smoking status
Former
|
32 Participants
n=5 Participants
|
|
Smoking status
Never
|
5 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
29 Participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
12 Participants
n=5 Participants
|
|
Histology
Adenosquamous
|
3 Participants
n=5 Participants
|
|
Histology
Large cell with neuroendocrine features
|
1 Participants
n=5 Participants
|
|
Histology
Mucinous adenocarcinoma
|
1 Participants
n=5 Participants
|
|
Prior surgery undergone
Yes
|
37 Participants
n=5 Participants
|
|
Prior surgery undergone
No
|
9 Participants
n=5 Participants
|
|
Prior systemic therapy received
Yes
|
5 Participants
n=5 Participants
|
|
Prior systemic therapy received
No
|
41 Participants
n=5 Participants
|
|
Prior radiation therapy received
Yes
|
23 Participants
n=5 Participants
|
|
Prior radiation therapy received
No
|
23 Participants
n=5 Participants
|
|
Brain metastases at enrollment (yes/no)
Yes
|
14 Participants
n=5 Participants
|
|
Brain metastases at enrollment (yes/no)
No
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 yearsProgression-free survival (PFS) will be defined as the time from first dosing date to the date of the first documented tumor progression determined by the investigator using RECIST 1.1 or death, whichever occurs first
Outcome measures
| Measure |
nivolumab, ipilimumab and paclitaxel
n=46 Participants
patients will be treated with nivolumab and ipilimumab in combination with weekly paclitaxel days 1 and 8 every 21 days until they experience unacceptable drug-related toxicity, disease progression or 24 months.
The dosing regimen will be: nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and paclitaxel 80 mg/m2 on days 1 and 8 of 1 21 day treatment cycle. Paclitaxel would be stopped after a total of 4-6 cycles of treatment.
Nivolumab: 360 mg intravenously every 3 weeks
Ipilimumab: 1 mg/kg intravenously over 30 minutes
Paclitaxel: 80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
|
|---|---|
|
Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors RECIST 1.1 (Brand Name) or Death, Whichever Occurs First
|
9.4 months
Interval 5.9 to 16.6
|
SECONDARY outcome
Timeframe: up to 4 yearsThe study will assess the number and percentage of participants who experience high grade (Grade 3-4 and Grade 5) treatment-related select and immune-mediated adverse events that include: pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, endocrinopathies, and hypersensitivity/infusion reaction events.
Outcome measures
| Measure |
nivolumab, ipilimumab and paclitaxel
n=46 Participants
patients will be treated with nivolumab and ipilimumab in combination with weekly paclitaxel days 1 and 8 every 21 days until they experience unacceptable drug-related toxicity, disease progression or 24 months.
The dosing regimen will be: nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and paclitaxel 80 mg/m2 on days 1 and 8 of 1 21 day treatment cycle. Paclitaxel would be stopped after a total of 4-6 cycles of treatment.
Nivolumab: 360 mg intravenously every 3 weeks
Ipilimumab: 1 mg/kg intravenously over 30 minutes
Paclitaxel: 80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
|
|---|---|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Adrenal insufficiency
|
10 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Fatigue
|
24 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Alopecia
|
17 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Anorexia
|
16 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Infusion-related reaction
|
15 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Diarrhea
|
10 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Rash maculopapular
|
9 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Pneumonitis
|
8 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Colitis
|
7 Participants
|
|
Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC.
Hypothyroidism
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsObjective Response Rate (ORR) defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Outcome measures
| Measure |
nivolumab, ipilimumab and paclitaxel
n=46 Participants
patients will be treated with nivolumab and ipilimumab in combination with weekly paclitaxel days 1 and 8 every 21 days until they experience unacceptable drug-related toxicity, disease progression or 24 months.
The dosing regimen will be: nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and paclitaxel 80 mg/m2 on days 1 and 8 of 1 21 day treatment cycle. Paclitaxel would be stopped after a total of 4-6 cycles of treatment.
Nivolumab: 360 mg intravenously every 3 weeks
Ipilimumab: 1 mg/kg intravenously over 30 minutes
Paclitaxel: 80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
|
|---|---|
|
Estimate the Overall Response Rate With the Study Combination.
Complete response
|
2 Participants
|
|
Estimate the Overall Response Rate With the Study Combination.
Partial response
|
20 Participants
|
|
Estimate the Overall Response Rate With the Study Combination.
Stable disease
|
19 Participants
|
|
Estimate the Overall Response Rate With the Study Combination.
Progressive disease
|
5 Participants
|
Adverse Events
nivolumab, ipilimumab and paclitaxel
Serious events: 26 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
nivolumab, ipilimumab and paclitaxel
n=46 participants at risk
patients will be treated with nivolumab and ipilimumab in combination with weekly paclitaxel days 1 and 8 every 21 days until they experience unacceptable drug-related toxicity, disease progression or 24 months.
The dosing regimen will be: nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and paclitaxel 80 mg/m2 on days 1 and 8 of 1 21 day treatment cycle. Paclitaxel would be stopped after a total of 4-6 cycles of treatment.
Nivolumab: 360 mg intravenously every 3 weeks
Ipilimumab: 1 mg/kg intravenously over 30 minutes
Paclitaxel: 80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
10.9%
5/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.2%
1/46 • up to 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/46 • up to 4 years
|
|
Cardiac disorders
Atrial flutter
|
2.2%
1/46 • up to 4 years
|
|
Cardiac disorders
Atrioventricular block complete
|
2.2%
1/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.2%
1/46 • up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.2%
1/46 • up to 4 years
|
|
Gastrointestinal disorders
Colitis
|
13.0%
6/46 • up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/46 • up to 4 years
|
|
Gastrointestinal disorders
Enterovesical fistula
|
2.2%
1/46 • up to 4 years
|
|
General disorders
Fatigue
|
2.2%
1/46 • up to 4 years
|
|
General disorders
Fever
|
2.2%
1/46 • up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.2%
1/46 • up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
2/46 • up to 4 years
|
|
Infections and infestations
Infections and infestations
|
2.2%
1/46 • up to 4 years
|
|
Infections and infestations
Lung infection
|
2.2%
1/46 • up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46 • up to 4 years
|
|
Infections and infestations
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify
|
2.2%
1/46 • up to 4 years
|
|
General disorders
Non-cardiac chest pain
|
2.2%
1/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
13.0%
6/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
1/46 • up to 4 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Specify
|
4.3%
2/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.3%
2/46 • up to 4 years
|
|
Infections and infestations
Sepsis
|
2.2%
1/46 • up to 4 years
|
|
Nervous system disorders
Stroke
|
2.2%
1/46 • up to 4 years
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
4.3%
2/46 • up to 4 years
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46 • up to 4 years
|
Other adverse events
| Measure |
nivolumab, ipilimumab and paclitaxel
n=46 participants at risk
patients will be treated with nivolumab and ipilimumab in combination with weekly paclitaxel days 1 and 8 every 21 days until they experience unacceptable drug-related toxicity, disease progression or 24 months.
The dosing regimen will be: nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and paclitaxel 80 mg/m2 on days 1 and 8 of 1 21 day treatment cycle. Paclitaxel would be stopped after a total of 4-6 cycles of treatment.
Nivolumab: 360 mg intravenously every 3 weeks
Ipilimumab: 1 mg/kg intravenously over 30 minutes
Paclitaxel: 80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
|
|---|---|
|
General disorders
Fatigue
|
58.7%
27/46 • up to 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.0%
17/46 • up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
37.0%
17/46 • up to 4 years
|
|
General disorders
Infusion related reaction
|
32.6%
15/46 • up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
23.9%
11/46 • up to 4 years
|
|
Endocrine disorders
Adrenal insufficiency
|
19.6%
9/46 • up to 4 years
|
|
Endocrine disorders
Hypothyroidism
|
17.4%
8/46 • up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.2%
7/46 • up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
15.2%
7/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.2%
7/46 • up to 4 years
|
|
Investigations
Weight loss
|
15.2%
7/46 • up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
6/46 • up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
5/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.9%
5/46 • up to 4 years
|
|
Infections and infestations
Mucosal infection
|
10.9%
5/46 • up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.7%
4/46 • up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
4/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
4/46 • up to 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.7%
4/46 • up to 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.7%
4/46 • up to 4 years
|
|
Nervous system disorders
Headache
|
8.7%
4/46 • up to 4 years
|
|
Vascular disorders
Hypotension
|
8.7%
4/46 • up to 4 years
|
|
Infections and infestations
Lung infection
|
8.7%
4/46 • up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
4/46 • up to 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
3/46 • up to 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
3/46 • up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
3/46 • up to 4 years
|
|
Endocrine disorders
Endocrine disorders - Other, Specify
|
13.0%
6/46 • up to 4 years
|
|
Vascular disorders
Hypertension
|
6.5%
3/46 • up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.5%
3/46 • up to 4 years
|
|
Infections and infestations
Infections and infestations - Other, Specify
|
6.5%
3/46 • up to 4 years
|
|
General disorders
Pain
|
6.5%
3/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.5%
3/46 • up to 4 years
|
|
Infections and infestations
Sinusitis
|
6.5%
3/46 • up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
6.5%
3/46 • up to 4 years
|
|
Infections and infestations
Thromboembolic event
|
6.5%
3/46 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.9%
11/46 • up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.6%
9/46 • up to 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place