Trial Outcomes & Findings for MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC) (NCT NCT02422381)
NCT ID: NCT02422381
Last Updated: 2026-02-18
Results Overview
Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity. Drug toxicity is defined as events that required holding or delaying treatment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
126 Days (six 21-day cycles)
Results posted on
2026-02-18
Participant Flow
Patients enrolled in the Phase I and II portions were evaluated together for outcomes. There were no DLTs, so no dose de-escalation was triggered and all 16 patients then received the same therapy. As such, outcomes were analyzed together.
Participant milestones
| Measure |
MK-3475 + Gemcitabine
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
Patients enrolled in the phase I and II portions were evaluated together for outcomes. There were no DLTs, so there was no dose de-escalation triggered and all 16 patients then received the same therapy, per protocol.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
MK-3475 + Gemcitabine
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
Patients enrolled in the phase I and II portions were evaluated together for outcomes. There were no DLTs, so there was no dose de-escalation triggered and all 16 patients then received the same therapy, per protocol.
|
|---|---|
|
Overall Study
Death
|
14
|
Baseline Characteristics
MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
MK-3475 + Gemcitabine
n=16 Participants
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=4 Participants
|
|
Age, Continuous
|
76 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=4 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 0 (Asymptomatic)
|
2 Participants
n=4 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 1 (Symptomatic but completely ambulatory)
|
14 Participants
n=4 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 2 (Symptomatic, <50% in bed during the day)
|
0 Participants
n=4 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 3 (Symptomatic, >50% in bed, but not bedbound)
|
0 Participants
n=4 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 4 (Bedbound)
|
0 Participants
n=4 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 5 (Death)
|
0 Participants
n=4 Participants
|
|
Tumor Histology
Adenocarcinoma
|
12 Participants
n=4 Participants
|
|
Tumor Histology
Squamous Cell Carcinoma
|
1 Participants
n=4 Participants
|
|
Tumor Histology
Non-Small Cell Lung Cancer (not otherwise specified)
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 126 Days (six 21-day cycles)Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity. Drug toxicity is defined as events that required holding or delaying treatment.
Outcome measures
| Measure |
MK-3475 + Gemcitabine
n=16 Participants
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
|
|---|---|
|
Dose Limiting Toxicities
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPatients will have CT scans after every two cycles for up to 2 years to assess changes in tumor sizes.
Outcome measures
| Measure |
MK-3475 + Gemcitabine
n=16 Participants
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
|
|---|---|
|
Progression Free Survival
|
3.10 months
Interval 2.6 to 5.68
|
SECONDARY outcome
Timeframe: Every 12 weeks (up to 2 years)Patients will be contacted every 12 weeks following end of treatment to determine survival status until death, withdrawal of consent, or the end of the study, whichever occurs first.
Outcome measures
| Measure |
MK-3475 + Gemcitabine
n=16 Participants
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
|
|---|---|
|
Overall Survival
|
8.20 months
Interval 5.03 to 28.29
|
SECONDARY outcome
Timeframe: up to 2 yearsPatients will have CT scans to assess changes in tumor sizes.
Outcome measures
| Measure |
MK-3475 + Gemcitabine
n=16 Participants
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
|
|---|---|
|
Disease Response
Complete Response
|
0 Participants
|
|
Disease Response
Partial Response
|
2 Participants
|
|
Disease Response
Stable Disease
|
9 Participants
|
|
Disease Response
Progressive Disease
|
5 Participants
|
Adverse Events
MK-3475 + Gemcitabine
Serious events: 9 serious events
Other events: 16 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
MK-3475 + Gemcitabine
n=16 participants at risk
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxemia respiratory failure
|
6.2%
1/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Bowel obstruction
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspneic episode
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Nervous system disorders
Encephalopathy
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Fever
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Hepatobiliary disorders
Transminitis
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
Other adverse events
| Measure |
MK-3475 + Gemcitabine
n=16 participants at risk
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
MK-3475: Investigational drug.
Gemcitabine: Standard care drug.
|
|---|---|
|
General disorders
Chills
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Excess sweating
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Fatigue
|
81.2%
13/16 • Number of events 20 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Fever
|
25.0%
4/16 • Number of events 6 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Flu like symptoms
|
37.5%
6/16 • Number of events 7 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Nervous system disorders
Frontal lobe burning sensation
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Paraesophageal hernia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Renal and urinary disorders
Hematuria
|
12.5%
2/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Blood and lymphatic system disorders
Hyperchloremic acidosis
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
56.2%
9/16 • Number of events 9 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Vascular disorders
Hypertension
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
12/16 • Number of events 15 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Coccyx pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Nervous system disorders
Cognitive changes
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
8/16 • Number of events 9 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Creatinine increased
|
25.0%
4/16 • Number of events 5 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Decreased breaths sounds
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
31.2%
5/16 • Number of events 5 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Injury, poisoning and procedural complications
Dog bite
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Dry cough
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Eye disorders
Dry eyes
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Dry oral mucosa
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
62.5%
10/16 • Number of events 12 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Renal and urinary disorders
Dysruia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Edema
|
31.2%
5/16 • Number of events 7 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar hemorrhage
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
8/16 • Number of events 9 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
8/16 • Number of events 9 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Psychiatric disorders
Anxiety
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
12.5%
2/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Nervous system disorders
Anosmia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Bilateral leg edema
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Bilateral lower extremity edema
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral rhonchi
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Body aches
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Cancer pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Non-cardiac chest pain
|
37.5%
6/16 • Number of events 7 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Cardiac disorders
Cardiac chest pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Cardiac disorders
Chest tightness
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Abdominal bloating
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • Number of events 5 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Abdominal soreness
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Abdominal swelling
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Absolute neutrophil count decreased
|
12.5%
2/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
31.2%
5/16 • Number of events 5 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
6/16 • Number of events 7 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Vascular disorders
Hypotension
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Blood and lymphatic system disorders
Hypouricemia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Ileal obstruction
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Increasing pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Increasing productive cough
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Left axillary pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Left hand infection
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Left hip pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Left leg pain
|
12.5%
2/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Left upper quadrant pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Malaise
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Eye disorders
Mild Blurry Vision
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
12.5%
2/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.2%
5/16 • Number of events 6 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Nervous system disorders
Neuropathy
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Neutrophil count decreased
|
37.5%
6/16 • Number of events 6 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Oral lesions
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Oral thrush
|
6.2%
1/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Pain
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in left flank
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Pain when swallowing
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Cardiac disorders
Paroxysmal atrial fibrillation episode
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Platelet count decreased
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Pneumonia
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Port discomfort
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Port site tenderness
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
37.5%
6/16 • Number of events 8 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.2%
5/16 • Number of events 7 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.8%
3/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Rectal pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi, right lung
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Right lateral thigh pain
|
6.2%
1/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Right side lower neck pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Reproductive system and breast disorders
Scrotal pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
18.8%
3/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Side pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
4/16 • Number of events 4 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Skin breakdown around port site
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Cold sore
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Soreness at surgical incision
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Subcutaneous nodules in left upper arm
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Submandibular adenopathy
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Swelling in ankle
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
General disorders
Tender nodule on left upper foot
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Nervous system disorders
Tingling in legs
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
2/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
6/16 • Number of events 8 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
Weight loss
|
12.5%
2/16 • Number of events 3 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
31.2%
5/16 • Number of events 8 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
|
Investigations
White blood cell decreased
|
18.8%
3/16 • Number of events 5 • Adverse events were collected over 6 21-day cycles (126 days). All-cause mortality was assessed up to 2 years from the end of treatment.
|
Additional Information
Dr. Rachel Sanborn
Earle A. Chiles Research Institute, Providence Cancer Institute
Phone: 503-215-1979
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place