Trial Outcomes & Findings for PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer (NCT NCT03179410)
NCT ID: NCT03179410
Last Updated: 2021-03-05
Results Overview
Overall response rate is determined by radiographic response assessment utilizing modified Prostate Cancer Working Group 3 (PCWG3) using Immune Response Evaluation Criteria In Solid Tumors Criteria (iRECIST 1.1). iRECIST is the modified RECIST 1.1 for immune-based therapeutics, to measure radiographic response rate in men with metastatic prostate cancer. Patients alive who had not progressed as of the last follow-up, had PFS censored at the last follow-up date. There are five categories overall responses: iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of CR or PD iUPD: immune unconfirmed progressive disease when PD is unconfirmed NE: not evaluable
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
baseline to end of treatment (approximately 6 months)
Results posted on
2021-03-05
Participant Flow
Participant milestones
| Measure |
Single Arm-arm Phase II Study of Avelumab
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer
Baseline characteristics by cohort
| Measure |
Single Arm-arm Phase II Study of Avelumab
n=15 Participants
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 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
|
|
Prior PSA
|
53.6 ng/ml
n=5 Participants
|
|
Karnofsky Performance Status Score
|
90 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to end of treatment (approximately 6 months)Overall response rate is determined by radiographic response assessment utilizing modified Prostate Cancer Working Group 3 (PCWG3) using Immune Response Evaluation Criteria In Solid Tumors Criteria (iRECIST 1.1). iRECIST is the modified RECIST 1.1 for immune-based therapeutics, to measure radiographic response rate in men with metastatic prostate cancer. Patients alive who had not progressed as of the last follow-up, had PFS censored at the last follow-up date. There are five categories overall responses: iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of CR or PD iUPD: immune unconfirmed progressive disease when PD is unconfirmed NE: not evaluable
Outcome measures
| Measure |
Single Arm-arm Phase II Study of Avelumab
n=15 Participants
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Number of Participants With Overall Response as Determined by iRECIST
iCR: immune complete response
|
1 Participants
|
|
Number of Participants With Overall Response as Determined by iRECIST
iCPD: immune confirmed progressive disease
|
1 Participants
|
|
Number of Participants With Overall Response as Determined by iRECIST
iSD: immune stable disease
|
3 Participants
|
|
Number of Participants With Overall Response as Determined by iRECIST
iUPD: immune unconfirmed progressive disease
|
9 Participants
|
|
Number of Participants With Overall Response as Determined by iRECIST
NE: not evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline to end of treatment (approximately 6 months)Overall response rate is determined by radiographic response assessment utilizing Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1). Patients alive who had not progressed as of the last follow-up, had PFS censored at the last follow-up date. There are four overall response categories: Complete Response (CR): disappearance of all target and non-target lesions Progressive Disease (PD): 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Stable Disease (SD): In the absence of CR and PD Unevaluable (NE)
Outcome measures
| Measure |
Single Arm-arm Phase II Study of Avelumab
n=15 Participants
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Efficacy of PD-L1 Inhibition With Avelumab as Determined by RECIST1.1
Progressive Disease (PD)
|
10 Participants
|
|
Efficacy of PD-L1 Inhibition With Avelumab as Determined by RECIST1.1
Stable Disease (SD)
|
3 Participants
|
|
Efficacy of PD-L1 Inhibition With Avelumab as Determined by RECIST1.1
Unevaluable (NE)
|
1 Participants
|
|
Efficacy of PD-L1 Inhibition With Avelumab as Determined by RECIST1.1
Complete Response (CR)
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline to end of treatment (approximately 6 months)Radiographic progression free survival (rPFS) as determined by PCWG3 and RECISTS1.1 criteria. Radiographic progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
Single Arm-arm Phase II Study of Avelumab
n=15 Participants
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Radiographic Progression Free Survival (rPFS)
|
1.8 month
Interval 1.6 to 2.0
|
SECONDARY outcome
Timeframe: Up to 23.5 monthsLength of patient's life after starting study
Outcome measures
| Measure |
Single Arm-arm Phase II Study of Avelumab
n=15 Participants
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Overall Survival
|
7.4 month
Interval 2.8 to 12.5
|
SECONDARY outcome
Timeframe: 28 days post-treatment (approximately 7 months)Number of Participants with Adverse Events
Outcome measures
| Measure |
Single Arm-arm Phase II Study of Avelumab
n=15 Participants
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Toxicity and Safety of PD-L1 Inhibition With Avelumab in Men With Metastatic Neuroendocrine-like Prostate Cancer
|
15 Participants
|
Adverse Events
Single Arm-arm Phase II Study of Avelumab
Serious events: 9 serious events
Other events: 15 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Single Arm-arm Phase II Study of Avelumab
n=15 participants at risk
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Psychiatric disorders
Delirium
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
General disorders
Fever
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
Surgical and medical procedures
Surgical and medical procedures - Other Specify; Brain mass removal
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other Specify; Brain mets
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Cardiac disorders
Pericarditis
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
Other adverse events
| Measure |
Single Arm-arm Phase II Study of Avelumab
n=15 participants at risk
Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Eye disorders
Blurred vision
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Eye disorders
Eye disorders - Other, Specify: DIPLOPIA
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Abdominal pain
|
26.7%
4/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Bloating
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Constipation
|
33.3%
5/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
6/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Specify: TOOTH FRACTURE
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Gastrointestinal disorders
Oral pain
|
20.0%
3/15 • Up to 30 days post last day of dosing
|
|
General disorders
Chills
|
20.0%
3/15 • Up to 30 days post last day of dosing
|
|
General disorders
Fatigue
|
40.0%
6/15 • Up to 30 days post last day of dosing
|
|
General disorders
Fever
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
General disorders
Infusion related reaction
|
60.0%
9/15 • Up to 30 days post last day of dosing
|
|
General disorders
Localized edema
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
General disorders
Malaise
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
General disorders
Pain
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Infections and infestations
Infections and infestations - Other, Specify: C. DIF
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Injury, poisoning and procedural complications
Fall
|
26.7%
4/15 • Up to 30 days post last day of dosing
|
|
Injury, poisoning and procedural complications
Fracture
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
3/15 • Up to 30 days post last day of dosing
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
3/15 • Up to 30 days post last day of dosing
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Investigations
Creatinine increased
|
20.0%
3/15 • Up to 30 days post last day of dosing
|
|
Investigations
Investigations - Other, Specify: POSITIVE FOR BLOOD IN STOOL
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Investigations
Weight loss
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
4/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
3/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
3/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Specify: GROIN STRAIN
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Specify: MUSCLE CRAMPS
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
Nervous system disorders
Encephalopathy
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Nervous system disorders
Nervous system disorders - Other, Specify: CAUDA EQUINA
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Psychiatric disorders
Confusion
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Psychiatric disorders
Delirium
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Psychiatric disorders
Restlessness
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Renal and urinary disorders
Urinary urgency
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Renal and urinary disorders
Urine discoloration
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Up to 30 days post last day of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • Up to 30 days post last day of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Specify: YAWNING
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: ABRASION RIGHT ELBOW
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: LEFT NOSTRIL SCAB
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: MONS PUBIS (HERPES)
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: RASH LEFT KNEE, MACULO-PAPULAR
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: WOUND ON BACK
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Specify: RIGHT PERCUTANEOUS NEPHROSTOMY TUBE PLACED
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Up to 30 days post last day of dosing
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place