Trial Outcomes & Findings for Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs (NCT NCT02350764)

Last Updated: 2024-05-29

Results Overview

confirmed partial + complete response will be assessed as part of this study. Tumor response will be assessed using RECIST 1.1. All responses must be confirmed on subsequent scan to be considered a true response. Tumor assessments will be performed after.6 weeks (+/- 1 week) and subsequently every six week (+/- 1 week) thereafter while on study until week 48. After week 48, tumor assessments will be conducted every 12 weeks (+/- week). Additional tumor assessments may be performed at the discretion of the treating physician.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

every 6 weeks (+/- 1 week) until week 48

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Nivolumab Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease\*, withdrawal of consent, or death. nivolumab pilimumab
Overall Study STARTED	29
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease\*, withdrawal of consent, or death. nivolumab pilimumab
Overall Study Adverse Event	4
Overall Study Death	3
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab n=29 Participants Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease\*, withdrawal of consent, or death. nivolumab pilimumab
Age, Continuous	61.9 years n=99 Participants
Sex: Female, Male Female	16 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	25 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	29 Participants n=99 Participants

PRIMARY outcome

Timeframe: every 6 weeks (+/- 1 week) until week 48

Outcome measures

Outcome measures
Measure	Nivolumab n=29 Participants Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease\*, withdrawal of consent, or death. nivolumab pilimumab
Best Overall Response Rate (Confirmed Partial + Complete Response) Will be Assessed as Part of This Study. Tumor Response Will be Assessed Using RECIST 1.1) Stable Disease	7 Participants
Best Overall Response Rate (Confirmed Partial + Complete Response) Will be Assessed as Part of This Study. Tumor Response Will be Assessed Using RECIST 1.1) Progression of Disease	5 Participants
Best Overall Response Rate (Confirmed Partial + Complete Response) Will be Assessed as Part of This Study. Tumor Response Will be Assessed Using RECIST 1.1) Partial Response	5 Participants
Best Overall Response Rate (Confirmed Partial + Complete Response) Will be Assessed as Part of This Study. Tumor Response Will be Assessed Using RECIST 1.1) Not entered	12 Participants

Adverse Events

Nivolumab

Serious events: 22 serious events

Other events: 29 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab n=29 participants at risk Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease\*, withdrawal of consent, or death. nivolumab pilimumab
Cardiac disorders Atrial fibrillation	3.4% 1/29 • 48 weeks
Cardiac disorders Cardiac arrest	3.4% 1/29 • 48 weeks
Cardiac disorders Palpitations	3.4% 1/29 • 48 weeks
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • 48 weeks
Gastrointestinal disorders Constipation	3.4% 1/29 • 48 weeks
Gastrointestinal disorders Nausea	3.4% 1/29 • 48 weeks
Gastrointestinal disorders Vomiting	3.4% 1/29 • 48 weeks
General disorders Death NOS	10.3% 3/29 • 48 weeks
General disorders Fatigue	3.4% 1/29 • 48 weeks
General disorders Neck edema	3.4% 1/29 • 48 weeks
Infections and infestations Abdominal infection	3.4% 1/29 • 48 weeks
Infections and infestations Bronchial infection	3.4% 1/29 • 48 weeks
Infections and infestations Infections and infestations - Other	3.4% 1/29 • 48 weeks
Infections and infestations Lung infection	3.4% 1/29 • 48 weeks
Infections and infestations Pleural infection	3.4% 1/29 • 48 weeks
Investigations Creatinine increased	3.4% 1/29 • 48 weeks
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • 48 weeks
Metabolism and nutrition disorders Hyponatremia	3.4% 1/29 • 48 weeks
Musculoskeletal and connective tissue disorders Chest wall pain	3.4% 1/29 • 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms ben/mal/unk	6.9% 2/29 • 48 weeks
Nervous system disorders Seizure	3.4% 1/29 • 48 weeks
Psychiatric disorders Confusion	3.4% 1/29 • 48 weeks
Psychiatric disorders Delirium	6.9% 2/29 • 48 weeks
Renal and urinary disorders Acute kidney injury	3.4% 1/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	3.4% 1/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Dyspnea	13.8% 4/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Hypoxia	3.4% 1/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Pleural effusion	13.8% 4/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.4% 1/29 • 48 weeks
Skin and subcutaneous tissue disorders Skin ulceration	3.4% 1/29 • 48 weeks
Vascular disorders Superior vena cava syndrome	3.4% 1/29 • 48 weeks
Vascular disorders Thromboembolic event	10.3% 3/29 • 48 weeks
Musculoskeletal and connective tissue disorders Back pain	3.4% 1/29 • 48 weeks
Infections and infestations Upper respiratory infection	3.4% 1/29 • 48 weeks
General disorders Pain	6.9% 2/29 • 48 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	3.4% 1/29 • 48 weeks

Other adverse events

Other adverse events
Measure	Nivolumab n=29 participants at risk Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease\*, withdrawal of consent, or death. nivolumab pilimumab
Metabolism and nutrition disorders Hyperglycemia	100.0% 29/29 • 48 weeks
Metabolism and nutrition disorders Hypoalbuminemia	93.1% 27/29 • 48 weeks
Blood and lymphatic system disorders Anemia	75.9% 22/29 • 48 weeks
Metabolism and nutrition disorders Hypomagnesemia	65.5% 19/29 • 48 weeks
Investigations Alkaline phosphatase increased	58.6% 17/29 • 48 weeks
General disorders Fatigue	58.6% 17/29 • 48 weeks
Metabolism and nutrition disorders Hyponatremia	58.6% 17/29 • 48 weeks
Metabolism and nutrition disorders Hypocalcemia	55.2% 16/29 • 48 weeks
Investigations Lymphocyte count decreased	51.7% 15/29 • 48 weeks
Investigations Platelet count decreased	48.3% 14/29 • 48 weeks
Investigations Aspartate aminotransferase increased	44.8% 13/29 • 48 weeks
Metabolism and nutrition disorders Hypokalemia	44.8% 13/29 • 48 weeks
Investigations Alanine aminotransferase increased	44.8% 13/29 • 48 weeks
Gastrointestinal disorders Constipation	44.8% 13/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Cough	44.8% 13/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Dyspnea	44.8% 13/29 • 48 weeks
Investigations INR increased	37.9% 11/29 • 48 weeks
Metabolism and nutrition disorders Anorexia	37.9% 11/29 • 48 weeks
General disorders Pain	34.5% 10/29 • 48 weeks
Metabolism and nutrition disorders Hypophosphatemia	34.5% 10/29 • 48 weeks
Musculoskeletal and connective tissue disorders Back pain	27.6% 8/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Pleural effusion	27.6% 8/29 • 48 weeks
Gastrointestinal disorders Nausea	27.6% 8/29 • 48 weeks
Gastrointestinal disorders Diarrhea	27.6% 8/29 • 48 weeks
Investigations Activated partial thromboplastin time prolonged	27.6% 8/29 • 48 weeks
Investigations White blood cell decreased	27.6% 8/29 • 48 weeks
Investigations Serum amylase increased	24.1% 7/29 • 48 weeks
Skin and subcutaneous tissue disorders Rash maculo-papular	24.1% 7/29 • 48 weeks
Metabolism and nutrition disorders Hyperkalemia	24.1% 7/29 • 48 weeks
Metabolism and nutrition disorders Hypoglycemia	24.1% 7/29 • 48 weeks
Skin and subcutaneous tissue disorders Pruritus	20.7% 6/29 • 48 weeks
Investigations Weight loss	20.7% 6/29 • 48 weeks
Skin and subcutaneous tissue disorders Dry skin	20.7% 6/29 • 48 weeks
General disorders Edema limbs	20.7% 6/29 • 48 weeks
Psychiatric disorders Anxiety	17.2% 5/29 • 48 weeks
Investigations Lipase increased	17.2% 5/29 • 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myalgia	17.2% 5/29 • 48 weeks
Investigations Creatinine increased	17.2% 5/29 • 48 weeks
Musculoskeletal and connective tissue disorders Arthralgia	17.2% 5/29 • 48 weeks
Nervous system disorders Paresthesia	17.2% 5/29 • 48 weeks
Psychiatric disorders Insomnia	17.2% 5/29 • 48 weeks
Investigations Blood bilirubin increased	13.8% 4/29 • 48 weeks
Infections and infestations Lung infection	13.8% 4/29 • 48 weeks
Investigations Cholesterol high	13.8% 4/29 • 48 weeks
Psychiatric disorders Depression	13.8% 4/29 • 48 weeks
Infections and infestations Skin infection	13.8% 4/29 • 48 weeks
Endocrine disorders Hyperthyroidism	13.8% 4/29 • 48 weeks
General disorders Fever	13.8% 4/29 • 48 weeks
Injury, poisoning and procedural complications Infusion related reaction	10.3% 3/29 • 48 weeks
General disorders Non-cardiac chest pain	10.3% 3/29 • 48 weeks
Gastrointestinal disorders Abdominal pain	10.3% 3/29 • 48 weeks
Vascular disorders Hot flashes	10.3% 3/29 • 48 weeks
Gastrointestinal disorders Vomiting	10.3% 3/29 • 48 weeks
Metabolism and nutrition disorders Hypercalcemia	10.3% 3/29 • 48 weeks
Gastrointestinal disorders Gastroesophageal reflux disease	10.3% 3/29 • 48 weeks
Metabolism and nutrition disorders Hypermagnesemia	10.3% 3/29 • 48 weeks
Nervous system disorders Headache	10.3% 3/29 • 48 weeks
Metabolism and nutrition disorders Hypernatremia	10.3% 3/29 • 48 weeks
Vascular disorders Thromboembolic event	10.3% 3/29 • 48 weeks
Vascular disorders Hypertension	10.3% 3/29 • 48 weeks
Endocrine disorders Hypothyroidism	10.3% 3/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	10.3% 3/29 • 48 weeks
Infections and infestations Upper respiratory infection	6.9% 2/29 • 48 weeks
Skin and subcutaneous tissue disorders Skin & subcutaneous tissue disorders Other, spec	6.9% 2/29 • 48 weeks
Nervous system disorders Seizure	6.9% 2/29 • 48 weeks
Eye disorders Watering eyes	6.9% 2/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Hypoxia	6.9% 2/29 • 48 weeks
Eye disorders Dry eye	6.9% 2/29 • 48 weeks
Investigations Hemoglobin increased	6.9% 2/29 • 48 weeks
Vascular disorders Hypotension	6.9% 2/29 • 48 weeks
Cardiac disorders Sinus tachycardia	6.9% 2/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Hoarseness	6.9% 2/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Sore throat	6.9% 2/29 • 48 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	6.9% 2/29 • 48 weeks
Ear and labyrinth disorders Tinnitus	6.9% 2/29 • 48 weeks
Cardiac disorders Palpitations	6.9% 2/29 • 48 weeks
Renal and urinary disorders Urinary frequency	6.9% 2/29 • 48 weeks
Gastrointestinal disorders Dysphagia	6.9% 2/29 • 48 weeks
Cardiac disorders Atrial fibrillation	6.9% 2/29 • 48 weeks
Nervous system disorders Peripheral sensory neuropathy	6.9% 2/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.9% 2/29 • 48 weeks
Investigations Neutrophil count decreased	6.9% 2/29 • 48 weeks

Additional Information

Dr. Adam Schoenfeld, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-4042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place