Trial Outcomes & Findings for Ipilimumab + Nivolumab w/Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer (NCT NCT03043599)
NCT ID: NCT03043599
Last Updated: 2024-12-20
Results Overview
Recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. Investigators will initially enroll 6 patients and wait until completion of the 13-week safety observation period following initiation of ipilimumab + nivolumab combination treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
13 weeks
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
Combination Therapy
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ipilimumab + Nivolumab w/Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=21 Participants
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 weeksRecommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. Investigators will initially enroll 6 patients and wait until completion of the 13-week safety observation period following initiation of ipilimumab + nivolumab combination treatment.
Outcome measures
| Measure |
Combination Therapy
n=21 Participants
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
|
|---|---|
|
Phase I: Confirmation of Recommended Phase II Dose
Ipilimumab
|
3 mg/kg dose
|
|
Phase I: Confirmation of Recommended Phase II Dose
Nivoumab
|
1 mg/kg dose
|
PRIMARY outcome
Timeframe: 6 monthsPFS is defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration (as defined above) or death due to any cause.
Outcome measures
| Measure |
Combination Therapy
n=21 Participants
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
|
|---|---|
|
Phase II: Progression Free Survival (PFS)
|
4.5 months
Interval 2.7 to 4.6
|
SECONDARY outcome
Timeframe: 1 yearOS is defined as the duration from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Combination Therapy
n=21 Participants
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
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|---|---|
|
Overall Survival (OS)
|
11.7 months
Interval 4.7 to 16.0
|
Adverse Events
Combination Therapy
Serious events: 13 serious events
Other events: 21 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Combination Therapy
n=21 participants at risk
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
4/21 • Number of events 7 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified -Other
|
33.3%
7/21 • Number of events 7 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Cardiac disorders
Pericardial effusion
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Colitis
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Neck Pain
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Infections and infestations
Urosepsis
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Infections and infestations
Lung Infection
|
28.6%
6/21 • Number of events 7 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Aspartate aminotransferase
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Blood bilirubin increased
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Platelet count decreased
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders -Other
|
4.8%
1/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - lower limb
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Cognitive disturbance
|
9.5%
2/21 • Number of events 3 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Vascular disorders
Thromboembolic event
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
23.8%
5/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
Other adverse events
| Measure |
Combination Therapy
n=21 participants at risk
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
14.3%
3/21 • Number of events 7 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
7/21 • Number of events 20 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
7/21 • Number of events 8 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Fatigue
|
28.6%
6/21 • Number of events 8 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Fever
|
38.1%
8/21 • Number of events 11 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Weight Loss
|
4.8%
1/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.0%
4/21 • Number of events 4 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
SIADH
|
4.8%
1/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Dizziness
|
33.3%
7/21 • Number of events 8 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Cognitive Disturbance
|
14.3%
3/21 • Number of events 4 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.6%
10/21 • Number of events 12 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
14.3%
3/21 • Number of events 3 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
6/21 • Number of events 8 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
23.8%
5/21 • Number of events 6 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Dry Mouth
|
28.6%
6/21 • Number of events 6 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Pain
|
23.8%
5/21 • Number of events 8 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
19.0%
4/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.8%
1/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Abdominal Pain
|
23.8%
5/21 • Number of events 6 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Psychiatric disorders
Insomnia
|
23.8%
5/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
4/21 • Number of events 4 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
6/21 • Number of events 8 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Esophagitis
|
47.6%
10/21 • Number of events 11 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Gait Disturbance
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Immune system disorders
Allergic Reaction
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Infections and infestations
Urinary Tract Infection
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
7/21 • Number of events 8 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.8%
5/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
28.6%
6/21 • Number of events 8 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 4 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Psychiatric disorders
Confusion
|
9.5%
2/21 • Number of events 6 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
19.0%
4/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Reproductive system and breast disorders
Breast Pain
|
4.8%
1/21 • Number of events 3 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Dehydration
|
23.8%
5/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Dysgeusia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Psychiatric disorders
Anxiety
|
19.0%
4/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Psychiatric disorders
Depression
|
19.0%
4/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Reproductive system and breast disorders
Gynecomastia
|
4.8%
1/21 • Number of events 3 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.5%
2/21 • Number of events 3 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Toothache
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Blood bilirubin increased
|
9.5%
2/21 • Number of events 4 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Renal and urinary disorders
Urinary retention
|
9.5%
2/21 • Number of events 4 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Paresthesia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.8%
5/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Edema Limbs
|
19.0%
4/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Cardiac disorders
Sinus tachycardia
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Infusion related reaction
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Infections and infestations
Infections and Investigations- Other
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Infections and infestations
Lung Infection
|
28.6%
6/21 • Number of events 9 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Vascular disorders
Thromboembolic event
|
23.8%
5/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Investigations
Platelet count decreased
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Memory impairment
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
3/21 • Number of events 3 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Colitis
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Renal and urinary disorders
Urinary frequency
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Stroke
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Infections and infestations
Esophageal infection
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Cardiac disorders
Sinus bradycardia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Chills
|
9.5%
2/21 • Number of events 3 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Cardiac disorders
Pericardial effusion
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Dysphagia
|
23.8%
5/21 • Number of events 5 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Infections and infestations
Bronchial infection
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.8%
1/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Nervous system disorders
Dysarthria
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • Number of events 4 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Vascular disorders
Hypotension
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
General disorders
Flu like symptoms
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Eye disorders
Eye Disorders - Other
|
4.8%
1/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Skin and subcutaneous tissue disorders
Rash, erythematous
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition disorders - Other
|
4.8%
1/21 • Number of events 1 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified -Other
|
9.5%
2/21 • Number of events 2 • 2 years
All Serious Adverse Events are reported, regardless of causality. Serious Adverse Events were reported during screening period and within 100 days of discontinuation of dosing.
|
Additional Information
Bradford Perez, MD
H Lee Moffitt Cancer Center & Research Institute
Phone: 813-745-8234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place