Trial Outcomes & Findings for Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC) (NCT NCT03406715)
NCT ID: NCT03406715
Last Updated: 2023-03-30
Results Overview
Response will be assessed primarily using the response evaluation criteria in solid tumors (RECIST v1.1). The immune related (ir)RECIST will also be used secondarily. DCR = Complete Response (CR) = Partial Response (PR) + Stable Disease (SD) rates. The disease control (DCR=CR+PR+SD) rates will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by group.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2023-03-30
Participant Flow
Participant milestones
| Measure |
Combination Immunotherapy Plus Vaccine
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
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|---|---|
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Overall Study
STARTED
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14
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)
Baseline characteristics by cohort
| Measure |
Combination Immunotherapy Plus Vaccine
n=14 Participants
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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6 Participants
n=39 Participants
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Age, Categorical
>=65 years
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8 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
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7 Participants
n=39 Participants
|
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Sex: Female, Male
Male
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7 Participants
n=39 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=39 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=39 Participants
|
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Race (NIH/OMB)
White
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14 Participants
n=39 Participants
|
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Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
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Region of Enrollment
United States
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14 participants
n=39 Participants
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PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Evaluable participants
Response will be assessed primarily using the response evaluation criteria in solid tumors (RECIST v1.1). The immune related (ir)RECIST will also be used secondarily. DCR = Complete Response (CR) = Partial Response (PR) + Stable Disease (SD) rates. The disease control (DCR=CR+PR+SD) rates will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by group.
Outcome measures
| Measure |
Combination Immunotherapy Plus Vaccine
n=11 Participants
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
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|---|---|
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Disease Control Rate (DCR)
|
42.85 percentage of participants
Interval 21.3 to 67.4
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Evaluable participants
The PFS, defined as time from enrollment (eligible date) to date of progression/death, whichever happens first, or censor at last clinical follow-up date. PFS will be summarized utilizing the K-M method.
Outcome measures
| Measure |
Combination Immunotherapy Plus Vaccine
n=14 Participants
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
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|---|---|
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Progression Free Survival (PFS)
|
63 days
Interval 56.0 to 334.0
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SECONDARY outcome
Timeframe: Up to 3 yearsThe OS, defined as the time from study enrollment (eligible date) to death from any cause. OS will be summarized utilizing the K-M method.
Outcome measures
| Measure |
Combination Immunotherapy Plus Vaccine
n=14 Participants
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
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|---|---|
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Overall Survival (OS)
|
120 days
Interval 67.0 to
upper limit was not reached
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Evaluable participants
Overall response rate (ORR=CR+PR) will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by group.
Outcome measures
| Measure |
Combination Immunotherapy Plus Vaccine
n=11 Participants
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
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|---|---|
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Overall Response Rate (ORR)
|
21.4 percentage of participants
Interval 7.57 to 47.5
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Adverse Events
Combination Immunotherapy Plus Vaccine
Serious events: 14 serious events
Other events: 14 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Combination Immunotherapy Plus Vaccine
n=14 participants at risk
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
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|---|---|
|
Investigations
Platelet count decreased
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Hepatobiliary disorders
Hepatic failure
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Investigations - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Death NOS
|
21.4%
3/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Psychiatric disorders
Confusion
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Encephalopathy
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Fatigue
|
21.4%
3/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Psychiatric disorders
Psychiatric disorders -Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Infections and infestations
Infections and Infestations - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Renal and urinary disorders
Renal and urinary disorders -Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Seizure
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
42.9%
6/14 • Number of events 6 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
Other adverse events
| Measure |
Combination Immunotherapy Plus Vaccine
n=14 participants at risk
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
|
|---|---|
|
General disorders
Fatigue
|
57.1%
8/14 • Number of events 8 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Pain
|
42.9%
6/14 • Number of events 9 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Chills
|
21.4%
3/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Fever
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Edema face
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Flu like symptoms
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Infusion related reaction
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Injection site reaction
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
General disorders
Irritability
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
6/14 • Number of events 12 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.7%
5/14 • Number of events 5 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.7%
5/14 • Number of events 12 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
28.6%
4/14 • Number of events 6 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
4/14 • Number of events 5 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
2/14 • Number of events 8 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
2/14 • Number of events 5 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
2/14 • Number of events 4 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Alkalosis
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
6/14 • Number of events 8 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
28.6%
4/14 • Number of events 4 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
35.7%
5/14 • Number of events 6 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
4/14 • Number of events 8 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • Number of events 4 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
4/14 • Number of events 7 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 7 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
28.6%
4/14 • Number of events 5 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
3/14 • Number of events 4 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Alkaline phosphatase increased
|
35.7%
5/14 • Number of events 9 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Weight loss
|
28.6%
4/14 • Number of events 10 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
21.4%
3/14 • Number of events 10 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
3/14 • Number of events 11 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Blood bilirubin increased
|
14.3%
2/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Lipase increased
|
14.3%
2/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Cholesterol high
|
7.1%
1/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Creatinine increased
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Investigations - Other
|
7.1%
1/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Lymphocyte count decreased
|
7.1%
1/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Platelet count decreased
|
7.1%
1/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Investigations
Serum amylase increased
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Headache
|
35.7%
5/14 • Number of events 5 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Dysgeusia
|
21.4%
3/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Amnesia
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Lethargy
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Memory impairment
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Nervous system disorders - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Neuralgia
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Seizure
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Nervous system disorders
Tremor
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
35.7%
5/14 • Number of events 8 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
2/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
21.4%
3/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Cardiac disorders
Sinus tachycardia
|
21.4%
3/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Cardiac disorders
Cardiac disorders - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Cardiac disorders
Chest pain - cardiac
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Psychiatric disorders
Confusion
|
21.4%
3/14 • Number of events 5 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Psychiatric disorders
Depression
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Infections and infestations
Infections and infestations - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Infections and infestations
Rash pustular
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 3 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Renal and urinary disorders
Hematuria
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
14.3%
2/14 • Number of events 2 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Vascular disorders
Flushing
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Eye disorders
Blurred vision
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Eye disorders
Eye pain
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Hepatobiliary disorders
Hepatic failure
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
|
Endocrine disorders
Adrenal insufficiency
|
7.1%
1/14 • Number of events 1 • Adverse Events collected from date of participant consent to 30 days post last treatment. (an average of 1 year). Survival was assessed up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place