Trial Outcomes & Findings for Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence (NCT NCT01147536)
NCT ID: NCT01147536
Last Updated: 2021-06-03
Results Overview
The ELISPOT assay was not developed for this study and no immunogenicity data are available.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
6-7 weeks post surgery up to Week 14
Results posted on
2021-06-03
Participant Flow
The study consisted of Part 1 (Part 1a \[assessment of immune variation\] and Part 2a \[assay standardization\]) and Part 2 (immune monitoring). Due to Business reasons, the study did not advanced to the Part 2 portion. The results presented below are for Part 1 only. Per planned analysis, data were analyzed and collected combined for Part 1a and 1b.
Participant milestones
| Measure |
HSPPC-96 Vaccine
Participants received up to 8 administrations of HSPPC-96 (heat shock protein peptide complex-96) (Vitespen or Oncophage) 25 micrograms \[µg\] intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses \[at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
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|---|---|
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Overall Study
STARTED
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12
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
HSPPC-96 Vaccine
Participants received up to 8 administrations of HSPPC-96 (heat shock protein peptide complex-96) (Vitespen or Oncophage) 25 micrograms \[µg\] intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses \[at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
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|---|---|
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Overall Study
Administrative study close
|
2
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Overall Study
Death
|
1
|
Baseline Characteristics
Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
Baseline characteristics by cohort
| Measure |
HSPPC-96 Vaccine
n=12 Participants
Participants received up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses \[at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
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|---|---|
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Age, Continuous
|
53.5 years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-7 weeks post surgery up to Week 14Population: No Participants Provided Immunology Data. No Participants Provided Immunology Data. The ELISPOT assay was not developed for this study, and no immunogenicity data were collected for analysis.
The ELISPOT assay was not developed for this study and no immunogenicity data are available.
Outcome measures
Outcome data not reported
Adverse Events
HSPPC-96 Vaccine
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HSPPC-96 Vaccine
n=12 participants at risk
Participants received up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses \[at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
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|---|---|
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Infections and infestations
Clostridium colitis
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
HSPPC-96 Vaccine
n=12 participants at risk
Participants received up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses \[at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypercorticoidism
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye discharge
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Keratoconjuctivitis sicca
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Loose stools
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Difficulty in walking
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
25.0%
3/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pancreatic anastomotic leak
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood pressure increased
|
16.7%
2/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear congestion
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lymph node neoplasm
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung nodule
|
16.7%
2/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
2/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haemodynamic instability
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
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Musculoskeletal and connective tissue disorders
Athralgia
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16.7%
2/12 • From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place