Trial Outcomes & Findings for Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer (NCT NCT03158129)

Last Updated: 2025-03-05

Results Overview

The percentage of viable tumor cells was averaged across all reviewed tumor slides from the lung resection specimen. The specimen was reviewed by two pathologists and average score was used. Tumors with ≤ 10% of viable tumor cells were considered to have undergone MPR. Patients who did not have surgery was considered to be no MPR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

101 participants

Primary outcome timeframe

The lung resection specimen was collected at surgery.

Results posted on

2025-03-05

Participant Flow

Phase 2, multi-arm study at the University of Texas MD Anderson Cancer Center recruited patients with resectable stage I-IIIA non-small cell lung cancer. It started on 2017-6-9. The first patient gave consent on 2017-6-16. Patients were randomized to either Arm A - Nivolumab or Arm B - Nivolumab + Ipilimumab. After completion, patients were enrolled in Arm C - Nivolumab + Chemotherapy from 2018-12-14 to 2019-7-22 and Arm D - Nivolumab + Ipilimumab + Chemotherapy from 2019-12-30 to 2020-12-1.

Fifty-three patients were enrolled in Arm A and Arm B, 9 of them were screen failures. Twenty-three patients were enrolled in Arm C, 1 of them was screen failure. Twenty-five patients were enrolled in Arm D, 3 of them were screen failures.

Participant milestones

Participant milestones
Measure	Arm A - Nivolumab Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Overall Study STARTED	23	21	22	22
Overall Study COMPLETED	21	16	22	20
Overall Study NOT COMPLETED	2	5	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A - Nivolumab Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Overall Study Adverse Event	0	1	0
Overall Study Death	0	0	1
Overall Study High surgical risk	1	1	0
Overall Study Progression	1	1	0
Overall Study Lack of resectability	0	1	0
Overall Study Declined surgery	0	1	0
Overall Study No longer surgical candidate	0	0	1

Baseline Characteristics

Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Total n=88 Participants Total of all reporting groups
Histology Adenocarcinoma	13 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	13 Participants n=4 Participants	55 Participants n=21 Participants
Stage Stage IIIA	5 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	33 Participants n=21 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	42 Participants n=21 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	9 Participants n=4 Participants	46 Participants n=21 Participants
Age, Continuous	65.9 YEARS n=5 Participants	66.2 YEARS n=7 Participants	69.5 YEARS n=5 Participants	63.1 YEARS n=4 Participants	65.9 YEARS n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	35 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	15 Participants n=4 Participants	53 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants	18 Participants n=4 Participants	74 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	23 participants n=5 Participants	21 participants n=7 Participants	22 participants n=5 Participants	22 participants n=4 Participants	88 participants n=21 Participants
Smoking status Never smoker	5 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	18 Participants n=21 Participants
Smoking status Former smoker	14 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	13 Participants n=4 Participants	56 Participants n=21 Participants
Smoking status Current smoker	4 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Stage Stage IA	4 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Stage Stage IB	7 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	16 Participants n=21 Participants
Stage Stage IIA	2 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Stage Stage IIB	5 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	16 Participants n=21 Participants
Histology Adenosquamous carcinoma	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Histology Carcinoma with neuroendocrine features	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Histology Large cell carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Histology Not otherwise specified NSCLC	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Histology Sarcomatoid carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Histology Squamous cell carcinoma	10 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	27 Participants n=21 Participants

PRIMARY outcome

Timeframe: The lung resection specimen was collected at surgery.

Population: Intention-to-treat popluation

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Major Pathologic Response (mPR) MPR	5 Participants	8 Participants	7 Participants	11 Participants
Major Pathologic Response (mPR) No MPR	18 Participants	13 Participants	15 Participants	11 Participants

SECONDARY outcome

Timeframe: The lung resection specimen was collected at surgery.

Population: Intention-to-treat popluation

The percentage of viable tumor cells was averaged across all reviewed tumor slides from the lung resection specimen. The specimen was reviewed by two pathologists and average score was used. Tumors with 0% of viable tumor cells were considered to have undergone pCR. Patients who did not have surgery was considered to be no pCR.

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Pathologic Complete Response (pCR) pCR	2 Participants	6 Participants	4 Participants	4 Participants
Pathologic Complete Response (pCR) No pCR	21 Participants	15 Participants	18 Participants	18 Participants

SECONDARY outcome

Timeframe: Reassessment after induction therapy

Population: Intention-to-treat population

Radiographic response to induction treatment was assessed by RECIST version 1.1

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Radiographic Response CR	0 Participants	1 Participants	0 Participants	0 Participants
Radiographic Response PR	5 Participants	3 Participants	9 Participants	6 Participants
Radiographic Response SD	15 Participants	13 Participants	13 Participants	14 Participants
Radiographic Response PD	3 Participants	3 Participants	0 Participants	1 Participants
Radiographic Response Not evaluable	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively

Population: Intention-to-treat population.

Overall survival was defined as the time from randomization (in Arm A and Arm B) or treatment initiation (in Arm C and Arm D) to the time of death from all causes or to the time of last follow-up.

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Overall Survival (OS)	NA Months Not reached	NA Months Not reached	NA Months Not reached	NA Months Not reached

SECONDARY outcome

Population: Intention-to-treat population

EFS was defined as the time from randomization (in Arm A and Arm B) or treatment initiation (in Arm C and Arm D) to any progression of primary lung cancer precluding planned surgery, any progression or recurrence (as assessed by imaging and/or histopathologically) of primary lung cancer after surgery, any progression of primary lung cancer in patients without surgery or death from all causes or to the time of last imaging.

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Event-free Survival (EFS)	NA Months Not reached	NA Months Interval 20.1 to Not reached	NA Months Interval 21.7 to Not reached	NA Months Not reached

SECONDARY outcome

Timeframe: At surgery

Population: Intention-to-treat population

The residual tumor (R) classification measures how well the lung tumor was removed by surgery in the anatomic extent. R0 means a complete resection. R1 means a macroscopically complete resection but with microscopic tumor at the surgical margin. R2 means a resection that leaves gross tumor behind. R0 resection is a better surgical outcome than R1, R2 resections and R2 is the worst surgical outcome. The number of R0, R1 and R2 resections were reported among the patients who underwent surgery.

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Residual Tumor Classification R0	21 Participants	16 Participants	20 Participants	19 Participants
Residual Tumor Classification R1	0 Participants	0 Participants	1 Participants	1 Participants
Residual Tumor Classification R2	0 Participants	0 Participants	1 Participants	0 Participants
Residual Tumor Classification No surgery	2 Participants	5 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 30 days after surgery

Population: Intention-to-treat population

The number of patients who had complications including pulmonary, cardiac, gastrointestinal, genitourinary, neurological, and wound within 30 days after surgery

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
30-day Postoperative Complication Complication	8 Participants	5 Participants	7 Participants	13 Participants
30-day Postoperative Complication No complication	13 Participants	11 Participants	15 Participants	7 Participants
30-day Postoperative Complication No surgery	2 Participants	5 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 90 days after surgery

Population: Intention-to-treat population

The number of patients who died within 90 days after surgery

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab n=23 Participants Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 Participants Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 Participants Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
90-day Mortality Dead	1 Participants	0 Participants	0 Participants	0 Participants
90-day Mortality Alive	20 Participants	16 Participants	22 Participants	20 Participants
90-day Mortality No surgery	2 Participants	5 Participants	0 Participants	2 Participants

Adverse Events

Arm A - Nivolumab

Serious events: 4 serious events

Other events: 22 other events

Deaths: 1 deaths

Arm B - Nivolumab + Ipilimumab

Serious events: 3 serious events

Other events: 21 other events

Deaths: 1 deaths

Arm C - Nivolumab + Chemotherapy

Serious events: 7 serious events

Other events: 22 other events

Deaths: 3 deaths

Arm D - Nivolumab + Ipilimumab + Chemotherapy

Serious events: 3 serious events

Other events: 22 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Arm A - Nivolumab n=23 participants at risk Induction nivolumab 3 mg/kg intravenous on days 1, 15, and 29 followed by surgery within 3 to 6 weeks.	Arm B - Nivolumab + Ipilimumab n=21 participants at risk Induction nivolumab 3 mg/kg intravenous (IV) on days 1, 15, and 29 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.	Arm C - Nivolumab + Chemotherapy n=22 participants at risk Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin and docetaxel (or pemetrexed) IV on days 1, 22, and 43 followed by surgery within 3 to 6 weeks.	Arm D - Nivolumab + Ipilimumab + Chemotherapy n=22 participants at risk Induction nivolumab 3 mg/kg intravenous (IV) plus cisplatin (or carboplatin) and docetaxel (or pemetrexed) IV on days 1, 22, and 43 plus ipilimumab 1 mg/kg IV on day 1 followed by surgery within 3 to 6 weeks.
Gastrointestinal disorders Diarrhea/Colitis	4.3% 1/23 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.8% 1/21 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.3% 1/23 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.8% 1/21 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Respiratory, thoracic and mediastinal disorders Hypoxia	4.3% 1/23 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Vascular disorders Thromboembolic event (pulmonary embolism)	4.3% 1/23 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Nervous system disorders Atypical Guillain-Barré syndrome	4.3% 1/23 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Injury, poisoning and procedural complications Fall	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.8% 1/21 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.8% 1/21 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.5% 1/22 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	13.6% 3/22 • Number of events 3 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.5% 1/22 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Infections and infestations Lung infection	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	9.1% 2/22 • Number of events 2 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.5% 1/22 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Cardiac disorders Pericardial tamponade	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.5% 1/22 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Metabolism and nutrition disorders Hyponatremia	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.5% 1/22 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Infections and infestations Sepsis	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	9.1% 2/22 • Number of events 2 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented
Respiratory, thoracic and mediastinal disorders Respiratory failutre	0.00% 0/23 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/21 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	0.00% 0/22 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented	4.5% 1/22 • Number of events 1 • Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively. The start date, stop date, grade determined by CTCAE version 4, attribution (unrelated, unlikely, possible, probable, definite) to induction treatment of the adverse event were documented

Other adverse events

Additional Information

Tina Cascone, MD

MD Anderson Cancer Center

Phone: 713-792-6363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place