Trial Outcomes & Findings for Paclitaxel and Pembrolizumab in Treating Patients With Refractory Metastatic Urothelial Cancer (NCT NCT02581982)
NCT ID: NCT02581982
Last Updated: 2023-01-10
Results Overview
The overall response rate will be performed in all patients that are evaluable for efficacy and will have one interim analysis. Overall response is complete response (CR) = Disappearance of all target lesions (PR) = at least a 30% decrease in sum of diameters, taking as reference the baseline sum diameters; stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters while on study; and progressive disease (PD) = at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Paclitaxel)
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab, Paclitaxel)
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Paclitaxel and Pembrolizumab in Treating Patients With Refractory Metastatic Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Paclitaxel)
n=27 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 8.84 • n=39 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Out of the 27 participants, only 25 were evaluable for response to treatment.
The overall response rate will be performed in all patients that are evaluable for efficacy and will have one interim analysis. Overall response is complete response (CR) = Disappearance of all target lesions (PR) = at least a 30% decrease in sum of diameters, taking as reference the baseline sum diameters; stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters while on study; and progressive disease (PD) = at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Paclitaxel)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Overall Response Rate
Complete Response
|
3 Participants
|
|
Overall Response Rate
Partial Response
|
6 Participants
|
|
Overall Response Rate
Stable Disease
|
9 Participants
|
|
Overall Response Rate
Progressive Disease
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearAll adverse events will be tabulated and presented by preferred term and/or system organ class and grade. All deaths and serious adverse events will be tabulated.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Paclitaxel)
n=27 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Serious adverse events
|
34 Adverse Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Adverse events
|
61 Adverse Events
|
SECONDARY outcome
Timeframe: At 6 monthsThe Kaplan Meier methods will be used to estimate progression free survival. The 6-month PFS will be compared to historical rates using a chi-square test. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)
Outcome measures
| Measure |
Treatment (Pembrolizumab, Paclitaxel)
n=27 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Progression Free Survival (Kaplan Meier Method)
|
44 percentage of participants
Interval 26.0 to 62.0
|
Adverse Events
Treatment (Pembrolizumab, Paclitaxel)
Serious events: 27 serious events
Other events: 27 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, Paclitaxel)
n=27 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Confusion
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Investigations
Creatinine increased
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
General disorders
Death
|
14.8%
4/27 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Duodenal obstruction
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
General disorders
Fever
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
3.7%
1/27 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Endocrine disorders
Hypethyroidism
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Infections and infestations
Lung infection
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Nervous system disorders
Memory impairment
|
3.7%
1/27 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Nervous system disorders
Presyncope
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Nervous system disorders
Somnolence
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Nervous system disorders
Stroke
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
14.8%
4/27 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - other
|
3.7%
1/27 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Surgical and medical procedures - other
|
3.7%
1/27 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, Paclitaxel)
n=27 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.9%
7/27 • Number of events 8 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
14.8%
4/27 • Number of events 9 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
25.9%
7/27 • Number of events 14 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.0%
10/27 • Number of events 24 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
74.1%
20/27 • Number of events 96 • 1 year
|
|
Psychiatric disorders
Anxiety
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
25.9%
7/27 • Number of events 13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
6/27 • Number of events 7 • 1 year
|
|
General disorders
Chills
|
18.5%
5/27 • Number of events 6 • 1 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
48.1%
13/27 • Number of events 61 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.3%
9/27 • Number of events 12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.9%
7/27 • Number of events 15 • 1 year
|
|
Investigations
Creatinine increased
|
37.0%
10/27 • Number of events 36 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
14.8%
4/27 • Number of events 13 • 1 year
|
|
Nervous system disorders
Dizziness
|
11.1%
3/27 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.9%
7/27 • Number of events 11 • 1 year
|
|
General disorders
Edema limbs
|
14.8%
4/27 • Number of events 9 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
General disorders
Fatigue
|
77.8%
21/27 • Number of events 66 • 1 year
|
|
General disorders
Fever
|
18.5%
5/27 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Nervous system disorders
Headache
|
22.2%
6/27 • Number of events 7 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
25.9%
7/27 • Number of events 12 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
59.3%
16/27 • Number of events 70 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
3/27 • Number of events 4 • 1 year
|
|
Vascular disorders
Hypertension
|
11.1%
3/27 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
63.0%
17/27 • Number of events 48 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
29.6%
8/27 • Number of events 13 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
6/27 • Number of events 16 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagenesemia
|
25.9%
7/27 • Number of events 8 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
44.4%
12/27 • Number of events 23 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
11.1%
3/27 • Number of events 8 • 1 year
|
|
General disorders
Infusion related reaction
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Insomnia
|
29.6%
8/27 • Number of events 22 • 1 year
|
|
Vascular disorders
Lymphedema
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
55.6%
15/27 • Number of events 42 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.9%
7/27 • Number of events 7 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
44.4%
12/27 • Number of events 23 • 1 year
|
|
Investigations
Neutrophil count decreased
|
14.8%
4/27 • Number of events 12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Cardiac disorders
Palpitations
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Nervous system disorders
Paresthesia
|
22.2%
6/27 • Number of events 16 • 1 year
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
6/27 • Number of events 10 • 1 year
|
|
Investigations
Platelet count decreased
|
33.3%
9/27 • Number of events 19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
2/27 • Number of events 5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.5%
5/27 • Number of events 13 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Infections and infestations
Sinusitis
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
14.8%
4/27 • Number of events 7 • 1 year
|
|
Renal and urinary disorders
Urinary tract pain
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
6/27 • Number of events 6 • 1 year
|
|
Investigations
Weight loss
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Investigations
White blood cell decreased
|
59.3%
16/27 • Number of events 48 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - other
|
7.4%
2/27 • Number of events 4 • 1 year
|
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-713-5440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place