Trial Outcomes & Findings for Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT03026062)
NCT ID: NCT03026062
Last Updated: 2026-08-05
Results Overview
Assess irPFS, which was defined as the time from the date of randomization to the earliest date of progression or death; subjects alive and progression free were censored at their last clinic visit where they were assessed for progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
63 months
Results posted on
2026-08-05
Participant Flow
Participant milestones
| Measure |
Sequential Arm
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
58
|
|
Overall Study
COMPLETED
|
38
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Sequential Arm
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Early Progression
|
2
|
0
|
Baseline Characteristics
Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Sequential Arm
n=42 Participants
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm
n=58 Participants
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
78 Participants
n=40 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=20 Participants
|
38 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=20 Participants
|
58 Participants
n=20 Participants
|
100 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=20 Participants
|
55 Participants
n=20 Participants
|
90 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=20 Participants
|
58 participants
n=20 Participants
|
100 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 63 monthsAssess irPFS, which was defined as the time from the date of randomization to the earliest date of progression or death; subjects alive and progression free were censored at their last clinic visit where they were assessed for progression.
Outcome measures
| Measure |
Sequential Arm - High Grade Serous
n=38 Participants
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm - High Grade Serous
n=23 Participants
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
Sequential Arm - Clear Cell
n=4 Participants
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm - Clear Cell
n=26 Participants
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
|---|---|---|---|---|
|
Immune-related Progression-free Survival (irPFS)
|
1.84 months
Interval 1.77 to 2.17
|
1.87 months
Interval 1.77 to 2.43
|
1.4 months
Interval 0.93 to
Insufficient number of participants with events
|
2.32 months
Interval 1.83 to 3.9
|
SECONDARY outcome
Timeframe: 63 monthsAdverse events (AEs) and serious AEs were recorded from the time of first protocol-specific intervention throughout the treatment period and including the follow-up period (30 days after the last dose of the study drug).
Outcome measures
| Measure |
Sequential Arm - High Grade Serous
n=38 Participants
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm - High Grade Serous
n=23 Participants
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
Sequential Arm - Clear Cell
n=4 Participants
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm - Clear Cell
n=26 Participants
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
|---|---|---|---|---|
|
Grade III or Higher Treatment Related Toxicity in Each Experimental Arm
|
9 Participants
|
7 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 63 monthsOS was estimated via the Kaplan-Meier method and compared with the log-rank test.
Outcome measures
| Measure |
Sequential Arm - High Grade Serous
n=38 Participants
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm - High Grade Serous
n=23 Participants
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
Sequential Arm - Clear Cell
n=4 Participants
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm - Clear Cell
n=26 Participants
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
10.61 months
Interval 5.95 to 15.34
|
7.26 months
Interval 4.24 to 15.57
|
3.73 months
Interval 1.23 to
Insufficient number of participants with events
|
14.3 months
Interval 6.47 to 41.7
|
Adverse Events
Sequential Arm
Serious events: 13 serious events
Other events: 37 other events
Deaths: 2 deaths
Combination Arm
Serious events: 13 serious events
Other events: 47 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Sequential Arm
n=42 participants at risk
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm
n=58 participants at risk
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/42 • Number of events 1 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Investigations
Blood prolactin abnormal
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Gastrointestinal disorders
Colonic perforation
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 3 • 63 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.9%
5/42 • Number of events 6 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Endocrine disorders
Endocrine - Other, cortisol insufficiency; hypophysitis
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
General disorders
Fever
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
4.8%
2/42 • Number of events 2 • 63 months
|
0.00%
0/58 • 63 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
Other adverse events
| Measure |
Sequential Arm
n=42 participants at risk
Tremelimumab 3 mg/kg IV every 4 weeks for up to 4 doses followed by Durvalumab 1.5 g IV every 4 weeks for up to 9 doses
|
Combination Arm
n=58 participants at risk
Tremelimumab 1 mg/kg IV plus Durvalumab 1.5 g IV every 4 weeks for up to 4 doses followed by Durvalumab monotherapy 1.5 g IV every 4 weeks for up to 9 doses
|
|---|---|---|
|
Nervous system disorders
Extrapyramidal disorder
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
General disorders
Fatigue
|
33.3%
14/42 • Number of events 17 • 63 months
|
22.4%
13/58 • Number of events 16 • 63 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
General disorders
Fever
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Gastrointestinal disorders
Gastrointestinal-Other, frequent small stools
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.4%
1/42 • Number of events 1 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Infections and infestations
Gum infection
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Nervous system disorders
Headache
|
7.1%
3/42 • Number of events 3 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Hepatobiliary disorders
Hepatic pain
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
4/42 • Number of events 4 • 63 months
|
17.2%
10/58 • Number of events 15 • 63 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Endocrine disorders
Hyperthyroidism
|
11.9%
5/42 • Number of events 6 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.1%
3/42 • Number of events 5 • 63 months
|
3.4%
2/58 • Number of events 3 • 63 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.8%
2/42 • Number of events 2 • 63 months
|
0.00%
0/58 • 63 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.5%
4/42 • Number of events 5 • 63 months
|
5.2%
3/58 • Number of events 5 • 63 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.1%
3/42 • Number of events 4 • 63 months
|
1.7%
1/58 • Number of events 2 • 63 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
1/42 • Number of events 1 • 63 months
|
6.9%
4/58 • Number of events 6 • 63 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Endocrine disorders
Hypothyroidism
|
9.5%
4/42 • Number of events 4 • 63 months
|
12.1%
7/58 • Number of events 7 • 63 months
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Investigations
Investigations - Other, TSH decreased
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Investigations - Other, TSH increased
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Investigations - Other, free T4 increased
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Infections and infestations
Laryngitis
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Investigations
Lipase increased
|
26.2%
11/42 • Number of events 12 • 63 months
|
13.8%
8/58 • Number of events 15 • 63 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 2 • 63 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
7/42 • Number of events 7 • 63 months
|
12.1%
7/58 • Number of events 8 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
General disorders
Pain
|
4.8%
2/42 • Number of events 2 • 63 months
|
0.00%
0/58 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/42 • Number of events 2 • 63 months
|
0.00%
0/58 • 63 months
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 3 • 63 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • Number of events 2 • 63 months
|
5.2%
3/58 • Number of events 4 • 63 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
7/42 • Number of events 8 • 63 months
|
32.8%
19/58 • Number of events 22 • 63 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.8%
2/42 • Number of events 2 • 63 months
|
0.00%
0/58 • 63 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
47.6%
20/42 • Number of events 25 • 63 months
|
22.4%
13/58 • Number of events 18 • 63 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Serum amylase increased
|
14.3%
6/42 • Number of events 7 • 63 months
|
17.2%
10/58 • Number of events 10 • 63 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Gastrointestinal disorders
Toothache
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Infections and infestations
Upper respiratory infection
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
7/42 • Number of events 9 • 63 months
|
6.9%
4/58 • Number of events 4 • 63 months
|
|
Investigations
Weight loss
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 3 • 63 months
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Number of events 1 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
9/42 • Number of events 11 • 63 months
|
25.9%
15/58 • Number of events 18 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic - Other, pancytopenia
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Gastrointestinal disorders
Bloating
|
11.9%
5/42 • Number of events 6 • 63 months
|
0.00%
0/58 • 63 months
|
|
Investigations
Blood bilirubin increased
|
7.1%
3/42 • Number of events 4 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Blood prolactin abnormal
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Nervous system disorders
Concentration impairment
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 1 • 63 months
|
0.00%
0/58 • 63 months
|
|
Gastrointestinal disorders
Constipation
|
9.5%
4/42 • Number of events 4 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
4/42 • Number of events 4 • 63 months
|
12.1%
7/58 • Number of events 8 • 63 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/42 • 63 months
|
5.2%
3/58 • Number of events 5 • 63 months
|
|
Investigations
Creatinine increased
|
7.1%
3/42 • Number of events 4 • 63 months
|
15.5%
9/58 • Number of events 11 • 63 months
|
|
Gastrointestinal disorders
Diarrhea
|
23.8%
10/42 • Number of events 18 • 63 months
|
34.5%
20/58 • Number of events 32 • 63 months
|
|
Gastrointestinal disorders
Dry mouth
|
23.8%
10/42 • Number of events 18 • 63 months
|
10.3%
6/58 • Number of events 6 • 63 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/42 • 63 months
|
5.2%
3/58 • Number of events 3 • 63 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
4/42 • Number of events 4 • 63 months
|
15.5%
9/58 • Number of events 10 • 63 months
|
|
General disorders
Edema limbs
|
2.4%
1/42 • Number of events 1 • 63 months
|
8.6%
5/58 • Number of events 5 • 63 months
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Endocrine disorders
Endocrine - Other, hypophysitis
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Endocrine disorders
Endocrine - Other, TSH increased
|
0.00%
0/42 • 63 months
|
10.3%
6/58 • Number of events 6 • 63 months
|
|
Endocrine disorders
Endocrine - Other, TSH decreased
|
0.00%
0/42 • 63 months
|
3.4%
2/58 • Number of events 2 • 63 months
|
|
Endocrine disorders
Endocrine - Other, total cortisol increased
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Endocrine disorders
Endocrine - Other, thyroid hormone abnormal
|
0.00%
0/42 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
2/42 • Number of events 2 • 63 months
|
0.00%
0/58 • 63 months
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
7/42 • Number of events 9 • 63 months
|
6.9%
4/58 • Number of events 4 • 63 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42 • 63 months
|
5.2%
3/58 • Number of events 4 • 63 months
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
1/42 • Number of events 1 • 63 months
|
1.7%
1/58 • Number of events 1 • 63 months
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
6/42 • Number of events 6 • 63 months
|
20.7%
12/58 • Number of events 17 • 63 months
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
7/42 • Number of events 9 • 63 months
|
8.6%
5/58 • Number of events 7 • 63 months
|
|
Blood and lymphatic system disorders
Anemia
|
9.5%
4/42 • Number of events 5 • 63 months
|
22.4%
13/58 • Number of events 16 • 63 months
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
2/42 • Number of events 2 • 63 months
|
15.5%
9/58 • Number of events 9 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • Number of events 1 • 63 months
|
6.9%
4/58 • Number of events 5 • 63 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.4%
1/42 • Number of events 2 • 63 months
|
0.00%
0/58 • 63 months
|
Additional Information
Amir A Jazaeri, MD
The University of Texas MD Anderson Cancer Center
Phone: (713) 745-1613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place