Trial Outcomes & Findings for Depletion of Myeloid Derived Suppressor Cells to Enhance Anti PD-1 Therapy (NCT NCT03302247)
NCT ID: NCT03302247
Last Updated: 2020-10-28
Results Overview
Immunosuppression in terms of number of circulating MDSC in the blood by comparing within each arm reduction in the number of MDSCs after each cycle of treatment
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
2 years
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Nivolumab+Gemcitabine
Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle
Nivolumab: Monoclonal antibody against non small cell lung cancer
Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Nivolumab+Gemcitabine
Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle
Nivolumab: Monoclonal antibody against non small cell lung cancer
Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment
|
|---|---|
|
Overall Study
the study has closed prematurely
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Depletion of Myeloid Derived Suppressor Cells to Enhance Anti PD-1 Therapy
Baseline characteristics by cohort
| Measure |
Nivolumab+Gemcitabine
n=3 Participants
Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle
Nivolumab: Monoclonal antibody against non small cell lung cancer
Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The study has closed prematurely. Insufficient data for analysis
Immunosuppression in terms of number of circulating MDSC in the blood by comparing within each arm reduction in the number of MDSCs after each cycle of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study has closed prematurely. Data was not collected
Evaluate if MDSC elimination by gemcitabine results in increase in T-cell activity
Outcome measures
Outcome data not reported
Adverse Events
Nivolumab+Gemcitabine
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nivolumab+Gemcitabine
n=3 participants at risk
Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle
Nivolumab: Monoclonal antibody against non small cell lung cancer
Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
33.3%
1/3 • 1 year
|
|
Investigations
Elevated CPK
|
33.3%
1/3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • 1 year
|
|
General disorders
Intractable leg pain
|
33.3%
1/3 • 1 year
|
|
General disorders
Intractable right hip pain
|
33.3%
1/3 • 1 year
|
|
General disorders
Intractable lower back pain
|
33.3%
1/3 • 1 year
|
Other adverse events
| Measure |
Nivolumab+Gemcitabine
n=3 participants at risk
Nivolumab infusion on day 1 and 15 with the addition of gencitabine on day 1, 8 and 15 of 28 day cycle
Nivolumab: Monoclonal antibody against non small cell lung cancer
Nivolumab+Gemcitabine: Gemcitabine is added to the Nivolumab treatment
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 6 • 1 year
|
|
General disorders
Chills
|
66.7%
2/3 • Number of events 3 • 1 year
|
|
General disorders
Fever
|
66.7%
2/3 • Number of events 2 • 1 year
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 2 • 1 year
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
3/3 • Number of events 3 • 1 year
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Number of events 8 • 1 year
|
|
Investigations
Creatinine increased
|
66.7%
2/3 • Number of events 2 • 1 year
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 7 • 1 year
|
|
Investigations
Weight loss
|
66.7%
2/3 • Number of events 3 • 1 year
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Number of events 6 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 7 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
3/3 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
3/3 • Number of events 5 • 1 year
|
|
Investigations
Anorexia
|
66.7%
2/3 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoantremia
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
3/3 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Infections and infestations
Lip infection
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - other
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 2 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 4 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place