Trial Outcomes & Findings for TVEC and Preop Radiation for Sarcoma (4 ml Dose) (NCT NCT02453191)
NCT ID: NCT02453191
Last Updated: 2024-06-20
Results Overview
A DLT is defined as any of the following talimogene laherparepvec-related toxicity or related to the combination of talimogene laherparepvec and radiation therapy during treatment and up to 4 weeks after the last talimogene laherparepvec injection: Grade 3 or greater immune-mediated adverse events, Grade 3 or greater allergic reactions, any grade plasmacytoma, any other unexpected grade 3 or greater hematologic or non-hematologic toxicity, with the exceptions of: any grade of alopecia, expected radiation related skin toxicity of any grade, Grade 3 arthralgia or myalgia, brief (\< 1 week) grade 3 fatigue, Grade 3 fever, Grade 3 diarrhea or vomiting responding to supportive case.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
14 weeks
Results posted on
2024-06-20
Participant Flow
Participant milestones
| Measure |
Treatment
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
TVEC and Preop Radiation for Sarcoma (4 ml Dose)
Baseline characteristics by cohort
| Measure |
Treatment
n=30 Participants
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: 6 participants were evaluable for DLT assessment
A DLT is defined as any of the following talimogene laherparepvec-related toxicity or related to the combination of talimogene laherparepvec and radiation therapy during treatment and up to 4 weeks after the last talimogene laherparepvec injection: Grade 3 or greater immune-mediated adverse events, Grade 3 or greater allergic reactions, any grade plasmacytoma, any other unexpected grade 3 or greater hematologic or non-hematologic toxicity, with the exceptions of: any grade of alopecia, expected radiation related skin toxicity of any grade, Grade 3 arthralgia or myalgia, brief (\< 1 week) grade 3 fatigue, Grade 3 fever, Grade 3 diarrhea or vomiting responding to supportive case.
Outcome measures
| Measure |
Treatment
n=6 Participants
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Phase 1b: Number of Subjects With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: In Phase 2, 24 subjects were accrued. One patient refused surgery resulting in 23 subjects being evaluated.
Pathologic tumor necrosis rate is defined as the percentage of subjects with pathologic tumor necrosis ≥ 95%.
Outcome measures
| Measure |
Treatment
n=23 Participants
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Phase 2: Pathologic Tumor Necrosis Rate
< 95%
|
18 Participants
|
|
Phase 2: Pathologic Tumor Necrosis Rate
≥ 95%
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Subjects completing Phase 1 and 2.
Overall response rate is defined as the percentage of patients with a confirmed complete or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT: Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is a 30% decrease in the sum of the longest dimensions of the target lesions, relative to baseline. Progressive disease (PD) is an increase of 20% or more in the sum of the longest dimension of target lesions. Stable disease (SD) is a decrease in the tumor size of \< 30% or an increase of \< 20%.
Outcome measures
| Measure |
Treatment
n=30 Participants
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Overall Response Rate
Complete Response
|
0 Participants
|
|
Overall Response Rate
Partial Response
|
1 Participants
|
|
Overall Response Rate
Stable Disease
|
20 Participants
|
|
Overall Response Rate
Progressive Disease
|
9 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Subjects completing Phase 1 and 2.
Progression-free survival is defined as the time from treatment initiation to the date of first documentation of disease progression or death due to any cause. Otherwise, patients are censored at the date of last radiographic assessment for progression.
Outcome measures
| Measure |
Treatment
n=30 Participants
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Percentage of Participants With 2 Year Progression-Free Survival
|
57 percentage of participants
Interval 37.0 to 72.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Subjects in Phase 1 and 2.
Overall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive.
Outcome measures
| Measure |
Treatment
n=30 Participants
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Percentage of Participants With 2 Year Overall Survival
|
77 percentage of participants
Interval 57.0 to 88.0
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: All 30 enrolled subjects were assessed for AEs
To further assess the safety of talimogene laherparepvec given concurrently with preoperative external beam radiation in sarcoma patients.Information regarding the occurrence of adverse events will be collected from the time the subject signs the informed consent form and throughout their participation in the study, including a period of 30 days after the last dose of study drug.
Outcome measures
| Measure |
Treatment
n=30 Participants
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
30 Participants
|
Adverse Events
Treatment
Serious events: 4 serious events
Other events: 30 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment
n=30 participants at risk
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Infections and infestations
Infections and infestations - Other
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
Other adverse events
| Measure |
Treatment
n=30 participants at risk
talimogene laherparepvec in combination with radiotherapy
talimogene laherparepvec: talimogene laherparepvec
Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
|
|---|---|
|
Vascular disorders
Flushing
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Vascular disorders
Hypertension
|
20.0%
6/30 • Number of events 19 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Vascular disorders
Thromboembolic event
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
3/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
36.7%
11/30 • Number of events 12 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
6/30 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue
|
20.0%
6/30 • Number of events 8 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
3/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
7/30 • Number of events 12 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
4/30 • Number of events 9 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Renal and urinary disorders
Bladder spasm
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Renal and urinary disorders
Hematuria
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other,
|
10.0%
3/30 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
3/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Renal and urinary disorders
Urine discoloration
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Psychiatric disorders
Agitation
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Psychiatric disorders
Anxiety
|
16.7%
5/30 • Number of events 13 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Psychiatric disorders
Delirium
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Psychiatric disorders
Hallucinations
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Psychiatric disorders
Insomnia
|
10.0%
3/30 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Dizziness
|
23.3%
7/30 • Number of events 15 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
5/30 • Number of events 8 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Headache
|
50.0%
15/30 • Number of events 26 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Nervous system disorders - Other,
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Neuralgia
|
6.7%
2/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Paresthesia
|
13.3%
4/30 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
4/30 • Number of events 5 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
5/30 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
5/30 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
3/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
3/30 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue
|
16.7%
5/30 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
5/30 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
2/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
12/30 • Number of events 22 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
9/30 • Number of events 16 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
3/30 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
26.7%
8/30 • Number of events 17 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
5/30 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.3%
4/30 • Number of events 7 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
2/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
2/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.3%
7/30 • Number of events 13 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
Alanine aminotransferase
|
20.0%
6/30 • Number of events 8 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
Alkaline phosphatase increased
|
13.3%
4/30 • Number of events 5 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
Carbon monoxide diffusing capacity
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
Creatinine increased
|
10.0%
3/30 • Number of events 8 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
10/30 • Number of events 30 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
Neutrophil count decreased
|
10.0%
3/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
Platelet count decreased
|
13.3%
4/30 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
Weight loss
|
20.0%
6/30 • Number of events 11 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Investigations
White blood cell decreased
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
86.7%
26/30 • Number of events 63 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural
|
6.7%
2/30 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Infections and infestations
Infections and infestations - Other,
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Infections and infestations
Skin infection
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Infections and infestations
Wound infection
|
6.7%
2/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Immune system disorders
Allergic reaction
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Immune system disorders
Immune system disorders - Other,
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Chills
|
60.0%
18/30 • Number of events 46 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Edema limbs
|
40.0%
12/30 • Number of events 19 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Fatigue
|
86.7%
26/30 • Number of events 71 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Fever
|
40.0%
12/30 • Number of events 16 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Flu like symptoms
|
46.7%
14/30 • Number of events 48 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
General disorders and administration site
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Infusion related reaction
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Injection site reaction
|
16.7%
5/30 • Number of events 10 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Localized edema
|
10.0%
3/30 • Number of events 5 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Malaise
|
13.3%
4/30 • Number of events 7 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
General disorders
Pain
|
60.0%
18/30 • Number of events 52 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
5/30 • Number of events 5 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Bloating
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Constipation
|
26.7%
8/30 • Number of events 14 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
9/30 • Number of events 24 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
4/30 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other,
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Nausea
|
53.3%
16/30 • Number of events 39 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Toothache
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
46.7%
14/30 • Number of events 28 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Eye disorders
Eye disorders - Other, specify
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Eye disorders
Photophobia
|
3.3%
1/30 • Number of events 5 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Ear and labyrinth disorders
Ear pain
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
1/30 • Number of events 9 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
2/30 • Number of events 7 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Cardiac disorders
Heart failure
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Cardiac disorders
Pericardial effusion
|
3.3%
1/30 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Cardiac disorders
Sinus bradycardia
|
3.3%
1/30 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
13.3%
4/30 • Number of events 8 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
70.0%
21/30 • Number of events 49 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
|
Additional Information
Varun Monga, MD
University of Iowa, Holden Comprehensive Cancer Cente
Phone: 319-384-9497
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place