Trial Outcomes & Findings for Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC (NCT NCT02259621)

Last Updated: 2025-12-03

Results Overview

Safety will be measured by drawing safety labs. (CBC and a Chemistry Panel will be drawn at 2 week intervals during Nivolumab administration). Grade 3 and 4 lab abnormalities will be recorded from both participating sites.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-12-03

Participant Flow

There were a total of 39 patients enrolled to this study; 9 participants enrolled to arm A, 16 participants enrolled onto arm B and 14 to C.

Participant milestones

Participant milestones
Measure	Arm A- Nivolumab and Ipilimumab One dose of Nivolumab 3mg/kg IV \& Ipilimumab 1mg/kg will be administered to enrolled patients on Day-42, then 2 doses of Nivolumab 3mg/kg will be administered to enrolled patients on Day-28 and Day-14	Arm B- Nivolumab Nivolumab administration: Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days. Nivolumab: Anti-PD-1 Therapy	Arm C- Nivolumab, Carboplatin, & Paclitaxel Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0. Nivolumab: Anti-PD-1 Therapy Carboplatin: Anti-PD-1 Therapy Paclitaxel: Anti-PD-1 Therapy
Overall Study STARTED	9	16	14
Overall Study COMPLETED	9	16	14
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A- Nivolumab and Ipilimumab n=9 Participants One dose of Nivolumab 3mg/kg IV \& Ipilimumab 1mg/kg will be administered to enrolled patients on Day-42, then 2 doses of Nivolumab 3mg/kg will be administered to enrolled patients on Day-28 and Day-14	Arm B- Nivolumab n=16 Participants Nivolumab administration: Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days. Nivolumab: Anti-PD-1 Therapy	Arm C- Nivolumab, Carboplatin, & Paclitaxel n=14 Participants Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0. Nivolumab: Anti-PD-1 Therapy Carboplatin: Anti-PD-1 Therapy Paclitaxel: Anti-PD-1 Therapy	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=9 Participants	5 Participants n=6 Participants	5 Participants n=9 Participants	14 Participants n=205 Participants
Age, Categorical >=65 years	5 Participants n=9 Participants	11 Participants n=6 Participants	9 Participants n=9 Participants	25 Participants n=205 Participants
Age, Continuous	68 years n=9 Participants	69 years n=6 Participants	68 years n=9 Participants	69 years n=205 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	7 Participants n=6 Participants	8 Participants n=9 Participants	17 Participants n=205 Participants
Sex: Female, Male Male	7 Participants n=9 Participants	9 Participants n=6 Participants	6 Participants n=9 Participants	22 Participants n=205 Participants
Race/Ethnicity, Customized Race/Ethnicity · White/Non-Hispanic	7 Participants n=9 Participants	14 Participants n=6 Participants	10 Participants n=9 Participants	31 Participants n=205 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American/Unknown	0 Participants n=9 Participants	1 Participants n=6 Participants	0 Participants n=9 Participants	1 Participants n=205 Participants
Race/Ethnicity, Customized Race/Ethnicity · White/Declined to answer	1 Participants n=9 Participants	1 Participants n=6 Participants	0 Participants n=9 Participants	2 Participants n=205 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unknown/Non-Hispanic	0 Participants n=9 Participants	0 Participants n=6 Participants	2 Participants n=9 Participants	2 Participants n=205 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaskan Native/Non-Hispanic	1 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants	2 Participants n=205 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other/Non-Hispanic	0 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants	1 Participants n=205 Participants
Region of Enrollment Canada	0 Participants n=9 Participants	2 Participants n=6 Participants	11 Participants n=9 Participants	13 Participants n=205 Participants
Region of Enrollment United States	9 Participants n=9 Participants	14 Participants n=6 Participants	3 Participants n=9 Participants	26 Participants n=205 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Arm A- Nivolumab and Ipilimumab n=9 Participants One dose of Nivolumab 3mg/kg IV \& Ipilimumab 1mg/kg will be administered to enrolled patients on Day-42, then 2 doses of Nivolumab 3mg/kg will be administered to enrolled patients on Day-28 and Day-14	Arm B- Nivolumab n=16 Participants Nivolumab administration: Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days. Nivolumab: Anti-PD-1 Therapy	Arm C- Nivolumab, Carboplatin, & Paclitaxel n=14 Participants Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0. Nivolumab: Anti-PD-1 Therapy Carboplatin: Anti-PD-1 Therapy Paclitaxel: Anti-PD-1 Therapy
Safety as Measured by Number of Participants With Grade 3 and 4 Lab Abnormalities, as Defined by CTCAE v4.03	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 8 weeks

Number of Grade 3 and 4 adverse events as defined by CTCAE v4.03 that occur while a subject is participating in the study.

Outcome measures

Outcome measures
Measure	Arm A- Nivolumab and Ipilimumab n=9 Participants One dose of Nivolumab 3mg/kg IV \& Ipilimumab 1mg/kg will be administered to enrolled patients on Day-42, then 2 doses of Nivolumab 3mg/kg will be administered to enrolled patients on Day-28 and Day-14	Arm B- Nivolumab n=16 Participants Nivolumab administration: Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days. Nivolumab: Anti-PD-1 Therapy	Arm C- Nivolumab, Carboplatin, & Paclitaxel n=14 Participants Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0. Nivolumab: Anti-PD-1 Therapy Carboplatin: Anti-PD-1 Therapy Paclitaxel: Anti-PD-1 Therapy
Safety as Assessed by Number of Grade 3 and 4 Adverse Events	1 events	1 events	1 events

SECONDARY outcome

Timeframe: 6 weeks

Pathologic response to neoadjuvant nivolumab, nivolumab plus ipilimumab, and nicvolumab, carboplatin, and paclitaxel in resected tumor and lymph nodes. The rate of major pathologic response, defined as \<10% residual viable tumor cells in the resection specimen will be compared to historic data with neoadjuvant chemotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks

Radiographic response to neoadjuvant nivolumab, nivolumab plus ipilimumab, and carboplatin and paclitaxel as defined by RECIST 1.1.

Outcome measures

Outcome data not reported

Adverse Events

Arm A- Nivolumab and Ipilimumab

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

Arm B- Nivolumab

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm C- Nivolumab, Carboplatin, & Paclitaxel

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A- Nivolumab and Ipilimumab n=9 participants at risk One dose of Nivolumab 3mg/kg IV \& Ipilimumab 1mg/kg will be administered to enrolled patients on Day-42, then 2 doses of Nivolumab 3mg/kg will be administered to enrolled patients on Day-28 and Day-14	Arm B- Nivolumab n=16 participants at risk Nivolumab administration: Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days. Nivolumab: Anti-PD-1 Therapy	Arm C- Nivolumab, Carboplatin, & Paclitaxel n=14 participants at risk Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0. Nivolumab: Anti-PD-1 Therapy Carboplatin: Anti-PD-1 Therapy Paclitaxel: Anti-PD-1 Therapy
Nervous system disorders posterior reversible encephalopathy syndrome	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/16 • From the time of first dose of study medication up to 8 weeks.	7.1% 1/14 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.
Skin and subcutaneous tissue disorders subcutaneous emphysema	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/16 • From the time of first dose of study medication up to 8 weeks.	7.1% 1/14 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.
Vascular disorders hypotension	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	6.2% 1/16 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
Respiratory, thoracic and mediastinal disorders pneumothorax	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	6.2% 1/16 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
General disorders infusion reaction	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	6.2% 1/16 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
Infections and infestations lung infection	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	6.2% 1/16 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
Cardiac disorders atrial fibrillation	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	6.2% 1/16 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
Respiratory, thoracic and mediastinal disorders hypoxia	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	12.5% 2/16 • Number of events 2 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
Infections and infestations sepsis	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	6.2% 1/16 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
Respiratory, thoracic and mediastinal disorders pneumonitis	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	6.2% 1/16 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
Respiratory, thoracic and mediastinal disorders pleural effusion	0.00% 0/9 • From the time of first dose of study medication up to 8 weeks.	6.2% 1/16 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.
Respiratory, thoracic and mediastinal disorders adult repiratory distress syndrome	11.1% 1/9 • Number of events 1 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/16 • From the time of first dose of study medication up to 8 weeks.	0.00% 0/14 • From the time of first dose of study medication up to 8 weeks.

Other adverse events

Additional Information

Jasmine Brooks

Johns Hopkins SKCCC Clinical Research Office Coordinating Center

Phone: 6673068335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place