Trial Outcomes & Findings for Phase II: Pembrolizumab/Carboplatin/Taxol in Epithelial Ovary Cancer (NCT NCT02766582)
NCT ID: NCT02766582
Last Updated: 2024-02-26
Results Overview
Time to progression free survival (PFS) is the period from study entry (first dose of therapy) until disease progression, death or date of last contact. All patients underwent baseline computed tomographic scans prior to initiation of therapy. The residual disease information was collected from surgical operative reports as well as post operative CT scans. Treatment responses were assessed with CA 125 at each cycle of therapy. CT scans were performed post-operatively prior to initiation of systemic therapy, at the completion of combination platinum, taxane, and pembrolizumab therapy, and at the completion of maintenance pembrolizumab therapy. CT scans were also performed with increasing CA 125 or if clinically indicated per treating physician and assessments were made using response evaluation criteria in solid tumor (RECIST) criteria defined as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in non-target l
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
measured from date of completion of primary therapy to the date of the first clinical, biochemical or radiologic evidence of disease progression or death due to any cause
Results posted on
2024-02-26
Participant Flow
Patients enrolled from academic gyn oncology practice between 2016 and 2020
Participant milestones
| Measure |
Chemotherapy Combined With Pembrolizumab
Single arm study:
Pembrolizumab IV every 21 days (200 mg) Carboplatin IV every 21 days Paclitaxel IV infusion (80 mg/m2) every 7 days for 6 cycles Followed by 12 months pembrolizumab IV every 21 days
Pembrolizumab: IV every 21 days at 200 mg
Carboplatin: IV every 21 days
Paclitaxel: IV infusion (80mg/m2) every 7 days for 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II: Pembrolizumab/Carboplatin/Taxol in Epithelial Ovary Cancer
Baseline characteristics by cohort
| Measure |
Chemotherapy Combined With Pembrolizumab
n=29 Participants
Single arm study:
Pembrolizumab IV every 21 days (200 mg) Carboplatin IV every 21 days Paclitaxel IV infusion (80 mg/m2) every 7 days for 6 cycles Followed by 12 months pembrolizumab IV every 21 days
Pembrolizumab: IV every 21 days at 200 mg
Carboplatin: IV every 21 days
Paclitaxel: IV infusion (80mg/m2) every 7 days for 6 cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 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
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
|
Stage III and IV
|
29 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: measured from date of completion of primary therapy to the date of the first clinical, biochemical or radiologic evidence of disease progression or death due to any causeTime to progression free survival (PFS) is the period from study entry (first dose of therapy) until disease progression, death or date of last contact. All patients underwent baseline computed tomographic scans prior to initiation of therapy. The residual disease information was collected from surgical operative reports as well as post operative CT scans. Treatment responses were assessed with CA 125 at each cycle of therapy. CT scans were performed post-operatively prior to initiation of systemic therapy, at the completion of combination platinum, taxane, and pembrolizumab therapy, and at the completion of maintenance pembrolizumab therapy. CT scans were also performed with increasing CA 125 or if clinically indicated per treating physician and assessments were made using response evaluation criteria in solid tumor (RECIST) criteria defined as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in non-target l
Outcome measures
| Measure |
Chemotherapy Combined With Pembrolizumab
n=29 Participants
Single arm study:
Pembrolizumab IV every 21 days (200 mg) Carboplatin IV every 21 days Paclitaxel IV infusion (80 mg/m2) every 7 days for 6 cycles Followed by 12 months pembrolizumab IV every 21 days
Pembrolizumab: IV every 21 days at 200 mg
Carboplatin: IV every 21 days
Paclitaxel: IV infusion (80mg/m2) every 7 days for 6 cycles
|
|---|---|
|
Progression Free Survival (PFS) of Combination Platinum Based Therapy With Anti-Programmed Death (PD)-1 Therapy Followed by Maintenance Anti-PD-1 Therapy in Patients With Epithelial Ovarian Cancer (EOC).
|
13.2 months
Interval 11.8 to 14.7
|
SECONDARY outcome
Timeframe: Time of enrollment until 18 months from initiation of therapyEach cycle is 21 days. All participants were asked to complete FACT-O surveys at baseline/ time of enrollment, at 3 months, 6 months and 18 months from initiation of therapy. FACT-O is a validated 26-item summary score 112 points that captures the FACT-General (FACT-G) QOL dimensions of Physical Well-Being (7 items), Functional Well-Being (7 items), and an Ovarian Cancer Subscale (12 items). FACT-0 is a survey with 39 items self administered survey. Each item is scored on 5 point Likert-type scale. The FACT-0 scoring range is from 0-44. The subscale scoring ranges for FACT-G is 0-108. The higher the total score the better the patient well-being. the outcome measure data represent FACT-G scoring as it is the section that pertains to QOL. https://www.facit.org/measures/FACT-O
Outcome measures
| Measure |
Chemotherapy Combined With Pembrolizumab
n=27 Participants
Single arm study:
Pembrolizumab IV every 21 days (200 mg) Carboplatin IV every 21 days Paclitaxel IV infusion (80 mg/m2) every 7 days for 6 cycles Followed by 12 months pembrolizumab IV every 21 days
Pembrolizumab: IV every 21 days at 200 mg
Carboplatin: IV every 21 days
Paclitaxel: IV infusion (80mg/m2) every 7 days for 6 cycles
|
|---|---|
|
Monitor Quality of Life During Combination Therapy and Single Agent Maintenance Therapy With Anti-PD-1 Therapy With the Functional Assessment of Cancer Therapy- Ovarian (FACT- O) Surveys at Intervals During Therapy.
18 months
|
86 score on a scale
Interval 69.0 to 99.0
|
|
Monitor Quality of Life During Combination Therapy and Single Agent Maintenance Therapy With Anti-PD-1 Therapy With the Functional Assessment of Cancer Therapy- Ovarian (FACT- O) Surveys at Intervals During Therapy.
screening
|
85 score on a scale
Interval 77.8 to 91.0
|
|
Monitor Quality of Life During Combination Therapy and Single Agent Maintenance Therapy With Anti-PD-1 Therapy With the Functional Assessment of Cancer Therapy- Ovarian (FACT- O) Surveys at Intervals During Therapy.
3 months
|
88 score on a scale
Interval 83.0 to 95.0
|
|
Monitor Quality of Life During Combination Therapy and Single Agent Maintenance Therapy With Anti-PD-1 Therapy With the Functional Assessment of Cancer Therapy- Ovarian (FACT- O) Surveys at Intervals During Therapy.
6 months
|
83.9 score on a scale
Interval 76.0 to 96.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At enrollment tissue from cytoreductive surgery will be obtained from pathology blocks.PD-L1 expression in preserved tissue obtained at the time of initial diagnosis for patients with suboptimally cytoreduced ovarian cancer using immunohistochemistry (IHC) of initial tumor samples and correlate with clinical outcomes of response and survival.
Outcome measures
Outcome data not reported
Adverse Events
Chemotherapy Combined With Pembrolizumab
Serious events: 7 serious events
Other events: 0 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Chemotherapy Combined With Pembrolizumab
n=29 participants at risk
Single arm study:
Pembrolizumab IV every 21 days (200 mg) Carboplatin IV every 21 days Paclitaxel IV infusion (80 mg/m2) every 7 days for 6 cycles Followed by 12 months pembrolizumab IV every 21 days
Pembrolizumab: IV every 21 days at 200 mg
Carboplatin: IV every 21 days
Paclitaxel: IV infusion (80mg/m2) every 7 days for 6 cycles
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
3.4%
1/29 • Number of events 1 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
3.4%
1/29 • Number of events 1 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Nervous system disorders
encephalopathy
|
3.4%
1/29 • Number of events 1 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Blood and lymphatic system disorders
neutropenia
|
13.8%
4/29 • Number of events 4 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress
|
6.9%
2/29 • Number of events 2 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Metabolism and nutrition disorders
hyponatremia
|
10.3%
3/29 • Number of events 5 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Blood and lymphatic system disorders
lymphopenia
|
13.8%
4/29 • Number of events 4 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Blood and lymphatic system disorders
anemia
|
24.1%
7/29 • Number of events 7 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Gastrointestinal disorders
nausea
|
6.9%
2/29 • Number of events 2 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Cardiac disorders
heart failure
|
3.4%
1/29 • Number of events 1 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Endocrine disorders
hypothyroidism
|
6.9%
2/29 • Number of events 2 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Musculoskeletal and connective tissue disorders
weakness
|
6.9%
2/29 • Number of events 2 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Nervous system disorders
dizziness
|
3.4%
1/29 • Number of events 1 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Gastrointestinal disorders
constipation
|
3.4%
1/29 • Number of events 1 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Infections and infestations
sepsis
|
6.9%
2/29 • Number of events 2 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Infections and infestations
lung infection
|
3.4%
1/29 • Number of events 1 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
|
Psychiatric disorders
depression
|
3.4%
1/29 • Number of events 1 • 19 months
AE shall mean any medical occurrence in a Study subject who is administered the Study Drug regardless of relationship with the Study Drug exists. An AE can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of the Study Drug. SAE shall mean any untoward medical occurrence in a Study subject who is administered the Study Drug that results in death, a life-threatening drug experience, requires inpatient hospitalization or prolongation of hospitalization
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place