Trial Outcomes & Findings for Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT03204812)
NCT ID: NCT03204812
Last Updated: 2024-10-15
Results Overview
Toxicity will be monitored in all patients who receive at least one dose of tremelimumab, even if the patient is not evaluable for the biomarker or efficacy endpoint. Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
from date of the first treatment, up to 43.6 months
Results posted on
2024-10-15
Participant Flow
Recruitment Details: July 2017- April 2019
31 participants consented, 5 participants were inevaluable.
Participant milestones
| Measure |
Treatment (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Tremelimumab, Durvalumab)
n=26 Participants
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from date of the first treatment, up to 43.6 monthsPopulation: One patient received only one dose of combination therapy and was excluded from efficacy analysis.
Toxicity will be monitored in all patients who receive at least one dose of tremelimumab, even if the patient is not evaluable for the biomarker or efficacy endpoint. Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03.
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab)
n=25 Participants
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Adverse Events
Adverse Events
|
236 adverse events
|
|
Number of Adverse Events
Serious Adverse Events
|
14 adverse events
|
SECONDARY outcome
Timeframe: from the first day of treatment, up to 43.6 monthsPopulation: One patient received only one dose of combination therapy and was excluded from efficacy analysis.
PSA PFS is defined as per Prostate Cancer Working Group 3 (PCWG3) criteria: time from start of therapy to first PSA increase of 25% and ≥2 ng/mL above the nadir, and which is confirmed by a second value ≥3 weeks later. PSA PFS were calculated from the first day of treatment and summarized by Kaplan-Meier methods.
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab)
n=25 Participants
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Prostate-specific Antigen (PSA) Progression Free Survival (PFS)
|
0.9 months
Interval 0.9 to 1.8
|
SECONDARY outcome
Timeframe: from first day of treatment, up to 43.6 monthsPopulation: One patient received only one dose of combination therapy and was excluded from efficacy analysis.
rPFS is measured from first dose to date of disease progression on CT and/or bone scan or death from any cause, whichever occurs first. Radiographic PFS will start at the first day of treatment and will be summarized by Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),as a 20% increase in the sum of the longest diameter of target lesions, or ameasurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab)
n=25 Participants
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Radiographic Progressive Free Survival (rPFS)
|
3.7 months
Interval 1.9 to 5.7
|
SECONDARY outcome
Timeframe: baseline, up to 43.6 monthsPopulation: One patient received only one dose of combination therapy and was excluded from efficacy analysis.
PSA decline will start at the first day of treatment and will be summarized by Kaplan-Meier. The numeric PSA value at maximal decline will be summarized by a boxplot and as a scatter plot of maximal decline by baseline PSA. PSA is produced by normal and cancerous prostate tissue. PSA levels are often elevated in men with prostate cancer.
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab)
n=25 Participants
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With PSA Decline of ≥50% From Start of Therapy
|
3 Participants
|
SECONDARY outcome
Timeframe: from start of treatment, up to 43.6 monthsPopulation: One patient received only one dose of combination therapy and was excluded from efficacy analysis.
Overall Survival is the time which begins at diagnosis (or at the start of treatment) and up to the time of death.
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab)
n=25 Participants
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median Overall Survival
|
28.1 months
Interval 14.5 to 37.3
|
Adverse Events
Treatment (Tremelimumab, Durvalumab)
Serious events: 10 serious events
Other events: 26 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Treatment (Tremelimumab, Durvalumab)
n=26 participants at risk
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
7.7%
2/26 • Number of events 3 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Diabetes type 1
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Blood and lymphatic system disorders
Lipase increased
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Infections and infestations
Lung infection
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Cord Compression
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
General disorders
Pain
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
Other adverse events
| Measure |
Treatment (Tremelimumab, Durvalumab)
n=26 participants at risk
Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
19.2%
5/26 • Number of events 7 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Alkaline phosphatase increased
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
10/26 • Number of events 17 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
19.2%
5/26 • Number of events 8 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
6/26 • Number of events 6 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
1/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Bloating
|
3.8%
1/26 • Number of events 3 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Eye disorders
Blurred vision
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Cardiac troponin I increased
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Colitis
|
7.7%
2/26 • Number of events 4 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 4 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Creatinine increased
|
11.5%
3/26 • Number of events 3 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Diarrhea
|
30.8%
8/26 • Number of events 13 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.5%
3/26 • Number of events 3 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
General disorders
Edema limbs
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Increased cortisol
|
19.2%
5/26 • Number of events 6 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Decreased cortisol
|
15.4%
4/26 • Number of events 5 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Hypophysitis
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Decreased ACTH
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Increased non-fasting blood glucose
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Diabetes Type 1
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
T4 decrease
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
General disorders
Fatigue
|
26.9%
7/26 • Number of events 7 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
General disorders
Fever
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
General disorders
Gait disturbance
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
GGT increased
|
7.7%
2/26 • Number of events 4 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.8%
1/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
2/26 • Number of events 7 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Hyperthyroidism
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.5%
3/26 • Number of events 4 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.8%
1/26 • Number of events 5 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.8%
1/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Endocrine disorders
Hypothyroidism
|
19.2%
5/26 • Number of events 5 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Decreased sedimentation rate
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Increased sedimentation rate
|
15.4%
4/26 • Number of events 4 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Increase CK
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Increase Aldolase
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Alkaline phosphate increase
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
ACTH Elevated
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Nervous system disorders
Lethargy
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Lipase increased
|
23.1%
6/26 • Number of events 14 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Lymphocyte count decreased
|
11.5%
3/26 • Number of events 9 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Nausea
|
11.5%
3/26 • Number of events 3 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Neutrophil count decreased
|
3.8%
1/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Platelet count decreased
|
11.5%
3/26 • Number of events 3 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
2/26 • Number of events 3 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
38.5%
10/26 • Number of events 14 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, pneumonia
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Serum amylase increased
|
23.1%
6/26 • Number of events 11 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Infections and infestations
Upper respiratory infection
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Renal and urinary disorders
Urinary incontinence
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
Weight loss
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Investigations
White blood cell decreased
|
7.7%
2/26 • Number of events 2 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, leg cramps
|
3.8%
1/26 • Number of events 1 • From the first dose through 30 days after the last dose of medication, up to 43.6 months
|
Additional Information
Dr. Sumit Subudhi, PhD-Associate Professor, Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 792-2830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place