Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC (NA_00092076)

• ClinicalTrials.gov Identifier: NCT02259621
• Recruitment Status: Active, not recruiting
• First Posted: October 8, 2014
• Results First Posted: March 20, 2024
• Last Update Posted: March 20, 2024
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small Cell Lung Cancer
• Interventions: Drug: Nivolumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Ipilimumab
• Enrollment: 39

Participant Flow

Recruitment Details
Pre-assignment Details	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.

Arm/Group Title	Arm A- Nivolumab and Ipilimumab	Arm B- Nivolumab	Arm C- Nivolumab, Carboplatin, & Paclitaxel
Arm/Group Description	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	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	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
Period Title: Overall Study
Started	9	16	14
Completed	9	16	14
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Arm A- Nivolumab and Ipilimumab	Arm B- Nivolumab	Arm C- Nivolumab, Carboplatin, & Paclitaxel	Total
Arm/Group Description		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	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	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 of all reporting groups
Overall Number of Baseline Participants		9	16	14	39
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	16 participants	14 participants	39 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	4 44.4%	5 31.3%	5 35.7%	14 35.9%
	>=65 years	5 55.6%	11 68.8%	9 64.3%	25 64.1%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	9 participants	16 participants	14 participants	39 participants
		68; (53 to 84)	69; (52 to 81)	68; (46 to 78)	69; (46 to 81)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	16 participants	14 participants	39 participants
	Female	2 22.2%	7 43.8%	8 57.1%	17 43.6%
	Male	7 77.8%	9 56.3%	6 42.9%	22 56.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race/Ethnicity	Number Analyzed	9 participants	16 participants	14 participants	39 participants
	White/Non-Hispanic	7 77.8%	14 87.5%	10 71.4%	31 79.5%
	Black or African American/Unknown	0 0.0%	1 6.3%	0 0.0%	1 2.6%
	White/Declined to answer	1 11.1%	1 6.3%	0 0.0%	2 5.1%
	Unknown/Non-Hispanic	0 0.0%	0 0.0%	2 14.3%	2 5.1%
	American Indian or Alaskan Native/Non-Hispanic	1 11.1%	0 0.0%	1 7.1%	2 5.1%
	Other/Non-Hispanic	0 0.0%	0 0.0%	1 7.1%	1 2.6%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	9 participants	16 participants	14 participants	39 participants
Canada		0 0.0%	2 12.5%	11 78.6%	13 33.3%
United States		9 100.0%	14 87.5%	3 21.4%	26 66.7%

Outcome Measures

1. Primary Outcome

Title	Safety as Measured by Number of Participants With Grade 3 and 4 Lab Abnormalities, as Defined by CTCAE v4.03
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A- Nivolumab and Ipilimumab	Arm B- Nivolumab	Arm C- Nivolumab, Carboplatin, & Paclitaxel
Arm/Group Description:	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	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	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 Number of Participants Analyzed	9	16	14
Measure Type: Count of Participants; Unit of Measure: Participants
	1 11.1%	1 6.3%	1 7.1%

2. Primary Outcome

Title	Safety as Assessed by Number of Grade 3 and 4 Adverse Events
Description	Number of Grade 3 and 4 adverse events as defined by CTCAE v4.03 that occur while a subject is participating in the study.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A- Nivolumab and Ipilimumab	Arm B- Nivolumab	Arm C- Nivolumab, Carboplatin, & Paclitaxel
Arm/Group Description:	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	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	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 Number of Participants Analyzed	9	16	14
Measure Type: Number; Unit of Measure: events
	1	1	1

3. Secondary Outcome

Title	Pathologic Response
Description	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.
Time Frame	6 weeks

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	Radiographic Response
Description	Radiographic response to neoadjuvant nivolumab, nivolumab plus ipilimumab, and carboplatin and paclitaxel as defined by RECIST 1.1.
Time Frame	5 weeks

Outcome Measure Data Not Reported

Adverse Events

Time Frame	From the time of first dose of study medication up to 8 weeks.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Arm A- Nivolumab and Ipilimumab		Arm B- Nivolumab		Arm C- Nivolumab, Carboplatin, & Paclitaxel
Arm/Group Description	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		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		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
All-Cause Mortality
	Arm A- Nivolumab and Ipilimumab		Arm B- Nivolumab		Arm C- Nivolumab, Carboplatin, & Paclitaxel
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	1/9 (11.11%)		0/16 (0.00%)		0/14 (0.00%)
Serious Adverse Events
	Arm A- Nivolumab and Ipilimumab		Arm B- Nivolumab		Arm C- Nivolumab, Carboplatin, & Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.11%)		4/16 (25.00%)		2/14 (14.29%)
Cardiac disorders
atrial fibrillation * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
General disorders
infusion reaction * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
Infections and infestations
lung infection * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
sepsis * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
Nervous system disorders
posterior reversible encephalopathy syndrome * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
Respiratory, thoracic and mediastinal disorders
pneumothorax * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
hypoxia * 1	0/9 (0.00%)	0	2/16 (12.50%)	2	0/14 (0.00%)	0
pneumonitis * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
pleural effusion * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
adult repiratory distress syndrome * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
Skin and subcutaneous tissue disorders
subcutaneous emphysema * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
Vascular disorders
hypotension * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
1 Term from vocabulary, CTCAE (4.0); * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm A- Nivolumab and Ipilimumab		Arm B- Nivolumab		Arm C- Nivolumab, Carboplatin, & Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100.00%)		15/16 (93.75%)		14/14 (100.00%)
Blood and lymphatic system disorders
anemia * 1	0/9 (0.00%)	0	4/16 (25.00%)	4	2/14 (14.29%)	2
blood and lymphatic system disorders - other * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
Cardiac disorders
myocardial infarction * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
chest pain - cardiac * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	1/14 (7.14%)	1
Ear and labyrinth disorders
hearing impaired * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
Endocrine disorders
hyperthyroidism * 1	1/9 (11.11%)	1	1/16 (6.25%)	1	0/14 (0.00%)	0
Eye disorders
blurred vision * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
eye pain * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
floaters * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
Gastrointestinal disorders
constipation * 1	1/9 (11.11%)	1	4/16 (25.00%)	4	8/14 (57.14%)	8
nausea * 1	2/9 (22.22%)	3	1/16 (6.25%)	1	6/14 (42.86%)	6
gastroesophageal reflux disease * 1	1/9 (11.11%)	1	3/16 (18.75%)	4	2/14 (14.29%)	3
diarrhea * 1	2/9 (22.22%)	2	1/16 (6.25%)	1	3/14 (21.43%)	3
mucositis oral * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	2/14 (14.29%)	2
vomiting * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	3/14 (21.43%)	3
abdominal pain * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
General disorders
non-cardiac chest pain * 1	2/9 (22.22%)	2	6/16 (37.50%)	6	0/14 (0.00%)	0
irritability * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
fatigue * 1	5/9 (55.56%)	5	6/16 (37.50%)	6	6/14 (42.86%)	7
localized edema * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
infusion related reaction * 1	1/9 (11.11%)	1	1/16 (6.25%)	1	0/14 (0.00%)	0
edema limbs * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	1/14 (7.14%)	1
chills * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	2/14 (14.29%)	2
neck edema * 1	2/9 (22.22%)	2	0/16 (0.00%)	0	0/14 (0.00%)	0
Infections and infestations
lip infection * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
skin infection * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
mucosal infection * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
urinary tract infection * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
tooth infection * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
lung infection * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
Injury, poisoning and procedural complications
venous injury * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
postoperative thoracic procedure complication * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
Metabolism and nutrition disorders
anorexia * 1	3/9 (33.33%)	4	2/16 (12.50%)	2	7/14 (50.00%)	8
hyponatremia * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
dehydration * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
hyperglycemia * 1	1/9 (11.11%)	1	1/16 (6.25%)	1	1/14 (7.14%)	1
Musculoskeletal and connective tissue disorders
neck pain * 1	2/9 (22.22%)	2	1/16 (6.25%)	1	0/14 (0.00%)	0
back pain * 1	3/9 (33.33%)	3	2/16 (12.50%)	2	0/14 (0.00%)	0
arthralgia * 1	4/9 (44.44%)	4	4/16 (25.00%)	4	1/14 (7.14%)	1
chest wall pain * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
arthritis * 1	1/9 (11.11%)	2	0/16 (0.00%)	0	1/14 (7.14%)	1
pain in extremity * 1	2/9 (22.22%)	2	0/16 (0.00%)	0	4/14 (28.57%)	5
myalgia * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
bone pain * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
Nervous system disorders
dizziness * 1	0/9 (0.00%)	0	3/16 (18.75%)	3	0/14 (0.00%)	0
seizure * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
headache * 1	2/9 (22.22%)	4	2/16 (12.50%)	2	1/14 (7.14%)	1
peripheral motor neuropathy * 1	0/9 (0.00%)	0	4/16 (25.00%)	4	2/14 (14.29%)	3
tremor * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
syncope * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
paresthesia * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	4/14 (28.57%)	4
dysgeusia * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	1/14 (7.14%)	1
recurrent laryngeal nerve palsy * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
Psychiatric disorders
anxiety * 1	3/9 (33.33%)	3	4/16 (25.00%)	4	1/14 (7.14%)	1
depression * 1	2/9 (22.22%)	2	1/16 (6.25%)	1	0/14 (0.00%)	0
insomnia * 1	1/9 (11.11%)	1	2/16 (12.50%)	2	0/14 (0.00%)	0
Renal and urinary disorders
urinary urgency * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
Reproductive system and breast disorders
breast pain * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
dyspnea * 1	5/9 (55.56%)	5	5/16 (31.25%)	6	6/14 (42.86%)	6
cough * 1	4/9 (44.44%)	4	6/16 (37.50%)	6	1/14 (7.14%)	1
wheezing * 1	2/9 (22.22%)	2	2/16 (12.50%)	2	0/14 (0.00%)	0
productive cough * 1	2/9 (22.22%)	2	2/16 (12.50%)	2	0/14 (0.00%)	0
bronchial obstruction * 1	0/9 (0.00%)	0	1/16 (6.25%)	1	0/14 (0.00%)	0
hoarseness * 1	1/9 (11.11%)	1	1/16 (6.25%)	1	1/14 (7.14%)	1
pneumothorax * 1	2/9 (22.22%)	2	3/16 (18.75%)	3	0/14 (0.00%)	0
dry cough * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
pneumonitis * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
epistaxis * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
sore throat * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	1/14 (7.14%)	1
sleep apnea * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
hypoxia * 1	1/9 (11.11%)	2	0/16 (0.00%)	0	0/14 (0.00%)	0
pleural effusion * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
Skin and subcutaneous tissue disorders
pruritis * 1	1/9 (11.11%)	2	2/16 (12.50%)	2	3/14 (21.43%)	3
rash maculo-papular * 1	2/9 (22.22%)	3	1/16 (6.25%)	1	5/14 (35.71%)	5
dry skin * 1	1/9 (11.11%)	1	3/16 (18.75%)	5	1/14 (7.14%)	3
alopecia * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	8/14 (57.14%)	8
rash acneiform * 1	0/9 (0.00%)	0	0/16 (0.00%)	0	1/14 (7.14%)	1
photosensitivity * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	0/14 (0.00%)	0
Surgical and medical procedures
surgical and medical procedures - other * 1	1/9 (11.11%)	1	0/16 (0.00%)	0	3/14 (21.43%)	3
Vascular disorders
hypertension * 1	0/9 (0.00%)	0	2/16 (12.50%)	2	0/14 (0.00%)	0
1 Term from vocabulary, CTCAE (4.0); * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Jasmine Brooks
• Organization: Johns Hopkins SKCCC Clinical Research Office Coordinating Center
• Phone: 6673068335
• EMail: jbrook54@jhmi.edu

Publications:

Zhang X, Schwartz JC, Guo X, Bhatia S, Cao E, Lorenz M, Cammer M, Chen L, Zhang ZY, Edidin MA, Nathenson SG, Almo SC. Structural and functional analysis of the costimulatory receptor programmed death-1. Immunity. 2004 Mar;20(3):337-47. doi: 10.1016/s1074-7613(04)00051-2. Erratum In: Immunity. 2004 May;20(5):651.

Dong H, Strome SE, Salomao DR, Tamura H, Hirano F, Flies DB, Roche PC, Lu J, Zhu G, Tamada K, Lennon VA, Celis E, Chen L. Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion. Nat Med. 2002 Aug;8(8):793-800. doi: 10.1038/nm730. Epub 2002 Jun 24. Erratum In: Nat Med 2002 Sep;8(9):1039.

Thompson RH, Kuntz SM, Leibovich BC, Dong H, Lohse CM, Webster WS, Sengupta S, Frank I, Parker AS, Zincke H, Blute ML, Sebo TJ, Cheville JC, Kwon ED. Tumor B7-H1 is associated with poor prognosis in renal cell carcinoma patients with long-term follow-up. Cancer Res. 2006 Apr 1;66(7):3381-5. doi: 10.1158/0008-5472.CAN-05-4303.

Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2.

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zhang J, Ji Z, Caushi JX, El Asmar M, Anagnostou V, Cottrell TR, Chan HY, Suri P, Guo H, Merghoub T, Chaft JE, Reuss JE, Tam AJ, Blosser RL, Abu-Akeel M, Sidhom JW, Zhao N, Ha JS, Jones DR, Marrone KA, Naidoo J, Gabrielson E, Taube JM, Velculescu VE, Brahmer JR, Housseau F, Hellmann MD, Forde PM, Pardoll DM, Ji H, Smith KN. Compartmental Analysis of T-cell Clonal Dynamics as a Function of Pathologic Response to Neoadjuvant PD-1 Blockade in Resectable Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Mar 15;26(6):1327-1337. doi: 10.1158/1078-0432.CCR-19-2931. Epub 2019 Nov 21.

Jafarnejad M, Gong C, Gabrielson E, Bartelink IH, Vicini P, Wang B, Narwal R, Roskos L, Popel AS. A Computational Model of Neoadjuvant PD-1 Inhibition in Non-Small Cell Lung Cancer. AAPS J. 2019 Jun 24;21(5):79. doi: 10.1208/s12248-019-0350-x.

Cottrell TR, Thompson ED, Forde PM, Stein JE, Duffield AS, Anagnostou V, Rekhtman N, Anders RA, Cuda JD, Illei PB, Gabrielson E, Askin FB, Niknafs N, Smith KN, Velez MJ, Sauter JL, Isbell JM, Jones DR, Battafarano RJ, Yang SC, Danilova L, Wolchok JD, Topalian SL, Velculescu VE, Pardoll DM, Brahmer JR, Hellmann MD, Chaft JE, Cimino-Mathews A, Taube JM. Pathologic features of response to neoadjuvant anti-PD-1 in resected non-small-cell lung carcinoma: a proposal for quantitative immune-related pathologic response criteria (irPRC). Ann Oncol. 2018 Aug 1;29(8):1853-1860. doi: 10.1093/annonc/mdy218.

Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT02259621
• Other Study ID Numbers: J1414; NA_00092076 ( Other Identifier: JHMIRB )
• First Submitted: September 18, 2014
• First Posted: October 8, 2014
• Results First Submitted: November 17, 2023
• Results First Posted: March 20, 2024
• Last Update Posted: March 20, 2024