Trial Outcomes & Findings for Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632) (NCT NCT03168464)
NCT ID: NCT03168464
Last Updated: 2023-04-24
Results Overview
To enhance the ORR to the combination of Ipi/Nivo in chemo-refractory NSCLC by preceding it with a combination of Ipi/RT to convert the irradiated tumor into an in situ vaccine and to double the ORR of Ipi/RT, from 18% based on intent to treat to 36%.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
2.5 Months, 6 Months, 3 years
Results posted on
2023-04-24
Participant Flow
Participant milestones
| Measure |
Immunotherapy + Radiation
Non-ablative radiotherapy (6GyX5) is directed to one lesion during a first immunotherapy treatment with Ipilimumab 3 mg/kg (± 24hrs from first RT dose). On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Ipilimumab: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study. On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Nivolumab: On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Radiation therapy: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Immunotherapy + Radiation
Non-ablative radiotherapy (6GyX5) is directed to one lesion during a first immunotherapy treatment with Ipilimumab 3 mg/kg (± 24hrs from first RT dose). On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Ipilimumab: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study. On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Nivolumab: On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Radiation therapy: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.
|
|---|---|
|
Overall Study
Death
|
9
|
|
Overall Study
Progression of disease
|
6
|
Baseline Characteristics
Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632)
Baseline characteristics by cohort
| Measure |
Immunotherapy + Radiation
n=15 Participants
Non-ablative radiotherapy (6GyX5) is directed to one lesion during a first immunotherapy treatment with Ipilimumab 3 mg/kg (± 24hrs from first RT dose). On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Ipilimumab: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study. On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Nivolumab: On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Radiation therapy: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.
|
|---|---|
|
Age, Continuous
|
65.31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2.5 Months, 6 Months, 3 yearsPopulation: Participants were not assessed at 3 years.
To enhance the ORR to the combination of Ipi/Nivo in chemo-refractory NSCLC by preceding it with a combination of Ipi/RT to convert the irradiated tumor into an in situ vaccine and to double the ORR of Ipi/RT, from 18% based on intent to treat to 36%.
Outcome measures
| Measure |
Immunotherapy + Radiation
n=15 Participants
Non-ablative radiotherapy (6GyX5) is directed to one lesion during a first immunotherapy treatment with Ipilimumab 3 mg/kg (± 24hrs from first RT dose). On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Ipilimumab: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study. On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Nivolumab: On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Radiation therapy: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.
|
|---|---|
|
Enhance Overall Response Rate (ORR) to the Combination of Ipi/Nivo in Chemo-refractory NSCLC and Double the ORR of Ipi/RT, From 18% Based on Intent to Treat to 36%.
2.5 Months
|
10 Participants
|
|
Enhance Overall Response Rate (ORR) to the Combination of Ipi/Nivo in Chemo-refractory NSCLC and Double the ORR of Ipi/RT, From 18% Based on Intent to Treat to 36%.
6 Months
|
9 Participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: None of the 15 enrolled subjects were enrolled at the 4 year time point.
changes in T-cell receptor (TCR) repertoire in peripheral blood are associated with response to treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: None of the 15 enrolled subjects were enrolled at the 4 year time point.
serum markers interferon-beta(IFN-B), C-X-C motif chemokine 11(CXCL11), soluble major histocompatibility complex class I-related chain A(sMICA), soluble major histocompatibility complex class I-related chain B (sMICB) levels/changes associated with patients' response to the treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: None of the 15 enrolled subjects were enrolled at the 4 year time point.
associations of ORR with changes in the microbiome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: None of the 15 enrolled subjects were enrolled at the 4 year time point.
Patients will be followed for progression free survival.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants were not assessed at 3 years.
Patients' time to progression will be assessed in this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants were not assessed at 3 years.
Patients' duration of response (DOR) will be assessed in this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: None of the 15 enrolled subjects were enrolled at the 4 year time point.
Patients will be followed for overall survival.
Outcome measures
Outcome data not reported
Adverse Events
Immunotherapy + Radiation
Serious events: 10 serious events
Other events: 15 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Immunotherapy + Radiation
n=15 participants at risk
Non-ablative radiotherapy (6GyX5) is directed to one lesion during a first immunotherapy treatment with Ipilimumab 3 mg/kg (± 24hrs from first RT dose). On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Ipilimumab: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study. On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Nivolumab: On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Radiation therapy: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
66.7%
10/15 • Number of events 10 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Hepatobiliary disorders
Immune mediated Hepatitis
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
Other adverse events
| Measure |
Immunotherapy + Radiation
n=15 participants at risk
Non-ablative radiotherapy (6GyX5) is directed to one lesion during a first immunotherapy treatment with Ipilimumab 3 mg/kg (± 24hrs from first RT dose). On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Ipilimumab: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study. On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Nivolumab: On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
Radiation therapy: Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
General disorders
Fatigue
|
100.0%
15/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
acute pulmonary embolus
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Anemia
|
46.7%
7/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
40.0%
6/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Absolute Lymphocyte count decreased
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
33.3%
5/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
5/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Psychiatric disorders
Anxiety
|
26.7%
4/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
40.0%
6/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
53.3%
8/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Gastrointestinal disorders
Bloating
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Hepatobiliary disorders
Blood Bilirubin Increased
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Eye disorders
Blurred Vision
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
General disorders
Chills
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
5/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.7%
7/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Renal and urinary disorders
Creatinine Increased
|
26.7%
4/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Nervous system disorders
Dizziness
|
20.0%
3/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Gastrointestinal disorders
Dry Mouth
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
73.3%
11/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Renal and urinary disorders
Dysuria
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Vascular disorders
Edema Limbs
|
20.0%
3/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
General disorders
Gait disturbance
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Renal and urinary disorders
Hematuria
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Hematoma
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Hepatobiliary disorders
Hepatitis
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Gastrointestinal disorders
Hoarseness
|
26.7%
4/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Endocrine disorders
Hot Flashes
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
46.7%
7/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Cardiac disorders
Hypertension
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Endocrine disorders
Hyperthyroidism
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Hypoalbuminea
|
60.0%
9/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Endocrine disorders
Hypophysitis
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Nervous system disorders
Insomnia
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Nervous system disorders
Neuralgia
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
General disorders
Pain
|
40.0%
6/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Nervous system disorders
Peripheral Neuropathy
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Investigations
Proteinuria
|
13.3%
2/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
46.7%
7/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
3/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Cardiac disorders
Sinus Tachycardia
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Obstruction
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Nervous system disorders
Vertigo
|
6.7%
1/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
|
Investigations
Weight Loss
|
46.7%
7/15 • Adverse events were assessed at 2.5 months, 6 months and All-Cause mortality was assessed up to 3 years.
Adverse events are documented based on the CTCAE version 5.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place