Trial Outcomes & Findings for Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (NCT NCT04526730)
NCT ID: NCT04526730
Last Updated: 2025-11-19
Results Overview
For each subject, the study intervention consists of 3 phases: (1) Neoadjuvant Phase; (2) Surgery Phase; (3) Adjuvant Phase. Completion of all 3 phases is required for primary completion of the study. The study protocol requires that all subjects will be followed for 4 weeks after last dose of nivolumab at End of Study (EOS) visit. That is 4 weeks after the conclusion of the adjuvant phase. For the purpose of reporting the primary outcome measure, Pathologic Complete Response will be estimated based on the proportion of participants who have completed the study phases and were found to have no viable tumor on histologic assessment at definitive surgery after the 12- week Neoadjuvant phase. Surgery will then be scheduled 2-4 weeks after neoadjuvant phase. This will be followed by the adjuvant phase. Therefore, the proportion of participants who continue in Pathologic Complete Response following completion of the 3 study phases would be reported.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
At least four weeks after the last dose of nivolumab at End of Study (EOS) visit
Results posted on
2025-11-19
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Treatment
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients
Baseline characteristics by cohort
| Measure |
Neoadjuvant Treatment
n=16 Participants
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Age, Continuous
|
69 years
|
|
Sex: Female, Male
Female
|
7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
|
Region of Enrollment
United States
|
16 participants
|
PRIMARY outcome
Timeframe: At least four weeks after the last dose of nivolumab at End of Study (EOS) visitFor each subject, the study intervention consists of 3 phases: (1) Neoadjuvant Phase; (2) Surgery Phase; (3) Adjuvant Phase. Completion of all 3 phases is required for primary completion of the study. The study protocol requires that all subjects will be followed for 4 weeks after last dose of nivolumab at End of Study (EOS) visit. That is 4 weeks after the conclusion of the adjuvant phase. For the purpose of reporting the primary outcome measure, Pathologic Complete Response will be estimated based on the proportion of participants who have completed the study phases and were found to have no viable tumor on histologic assessment at definitive surgery after the 12- week Neoadjuvant phase. Surgery will then be scheduled 2-4 weeks after neoadjuvant phase. This will be followed by the adjuvant phase. Therefore, the proportion of participants who continue in Pathologic Complete Response following completion of the 3 study phases would be reported.
Outcome measures
| Measure |
Neoadjuvant Treatment
n=15 Participants
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Pathologic Complete Response
|
9 Participants
|
SECONDARY outcome
Timeframe: Conclusion of the neoadjuvant phase.Preoperative ORR assessed by Investigator based on RECIST v1.1 at the conclusion of the Neoadjuvant phase.
Outcome measures
| Measure |
Neoadjuvant Treatment
n=16 Participants
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Objective Response Rate
|
10 Participants
|
SECONDARY outcome
Timeframe: At least four weeks after the last dose of nivolumab at End of Study (EOS) visitRFS assessed by Investigator based on RECIST v1.1 at least four weeks after the last dose of nivolumab at End of Study (EOS) visit.
Outcome measures
| Measure |
Neoadjuvant Treatment
n=16 Participants
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Relapse Free Survival
|
93 1-year RFS Probability
Interval 80.0 to 100.0
|
SECONDARY outcome
Timeframe: At 1 year after start of therapyOverall survival at 1 year after start of therapy.
Outcome measures
| Measure |
Neoadjuvant Treatment
n=16 Participants
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Overall Survival
|
94 1 Year OS Percent Probability
Interval 83.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 5 years after start of therapyTo determine the safety and tolerability of combined treatment as neoadjuvant therapy will be based on the frequency of AEs
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16 weeks after start or therapyDefinitive surgery will be planned at about 12 weeks. Participants will be monitored for surgical delay (either due to toxicity and/or tumor progression). Defined as the number of participants who had Surgery delayed due to progression.
Outcome measures
| Measure |
Neoadjuvant Treatment
n=16 Participants
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Risk of Surgical Delay
|
1 Participants
|
Adverse Events
Neoadjuvant Treatment
Serious events: 8 serious events
Other events: 16 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Neoadjuvant Treatment
n=16 participants at risk
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Cardiac disorders
Myocardial infarction
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Pancreatitis
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Flu like symptoms
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Hepatobiliary disorders
Cholecystitis
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Immune system disorders
Allergic reaction
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Stroke
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
Other adverse events
| Measure |
Neoadjuvant Treatment
n=16 participants at risk
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Dizziness
|
31.2%
5/16 • Number of events 6 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Number of events 7 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Ataxia
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Concentration impairment
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Stroke
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Nervous system disorders
Vasovagal reaction
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
8/16 • Number of events 21 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Infections and infestations
Infections and infestations - Other, specify
|
18.8%
3/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Infections and infestations
Kidney infection
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Infections and infestations
Pelvic infection
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Injury, poisoning and procedural complications
Fall
|
18.8%
3/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Injury, poisoning and procedural complications
Burn
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.5%
6/16 • Number of events 7 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Psychiatric disorders
Agitation
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Psychiatric disorders
Hallucinations
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 4 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Cardiac disorders
Sinus bradycardia
|
18.8%
3/16 • Number of events 4 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Cardiac disorders
Myocardial infarction
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Cardiac disorders
Chest pain - cardiac
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Renal and urinary disorders
Renal calculi
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Renal and urinary disorders
Cystitis noninfective
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Renal and urinary disorders
Hematuria
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Vascular disorders
Hypertension
|
31.2%
5/16 • Number of events 10 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Vascular disorders
Hypotension
|
18.8%
3/16 • Number of events 4 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Vascular disorders
Lymphedema
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
2/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Endocrine disorders
Hypophysitis
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Endocrine disorders
Hypopituitarism
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Hepatobiliary disorders
Cholecystitis
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Immune system disorders
Immune system disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
56.2%
9/16 • Number of events 12 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
43.8%
7/16 • Number of events 13 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.2%
5/16 • Number of events 5 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
4/16 • Number of events 4 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
4/16 • Number of events 6 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
3/16 • Number of events 4 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
2/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
93.8%
15/16 • Number of events 84 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Investigations - Other, specify
|
31.2%
5/16 • Number of events 9 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
4/16 • Number of events 12 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Creatinine increased
|
25.0%
4/16 • Number of events 5 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
3/16 • Number of events 11 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
INR increased
|
18.8%
3/16 • Number of events 5 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Thyroid stimulating hormone increased
|
18.8%
3/16 • Number of events 4 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Weight loss
|
12.5%
2/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
White blood cell decreased
|
12.5%
2/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Fatigue
|
56.2%
9/16 • Number of events 14 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Flu like symptoms
|
18.8%
3/16 • Number of events 4 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Chills
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Edema limbs
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Pain
|
12.5%
2/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Disease progression
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Localized edema
|
6.2%
1/16 • Number of events 1 • 1 year
Treatment Emergent: Related + Unrelated
|
|
General disorders
Neck edema
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Diarrhea
|
43.8%
7/16 • Number of events 14 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Number of events 8 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 5 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Colitis
|
18.8%
3/16 • Number of events 4 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Pancreatitis
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.2%
5/16 • Number of events 7 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.8%
3/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
2/16 • Number of events 2 • 1 year
Treatment Emergent: Related + Unrelated
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
2/16 • Number of events 3 • 1 year
Treatment Emergent: Related + Unrelated
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place