Trial Outcomes & Findings for Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC). (NCT NCT02834975)
NCT ID: NCT02834975
Last Updated: 2023-11-07
Results Overview
The pORR will be calculated as the percentage of participants with pathologic complete response (pCR) and pathologic partial response (pPR) overall as best response. For this protocol, pathologic complete response (pCR) will be defined as no residual macroscopic or (viable) microscopic disease. Pathologic partial response (pPR) will be defined as the presence of residual (viable) microscopic tumor, and the size of the largest focus will be provided for possible outcome correlation.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to 48 months
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Pembrolizumab, Paclitaxel + Carboplatin
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.
Pembrolizumab: Pembrolizumab on Day 1 of each cycle.
Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;
\- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.
Carboplatin: Carboplatin IV on Day 1 of each cycle.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Pembrolizumab, Paclitaxel + Carboplatin
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.
Pembrolizumab: Pembrolizumab on Day 1 of each cycle.
Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;
\- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.
Carboplatin: Carboplatin IV on Day 1 of each cycle.
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).
Baseline characteristics by cohort
| Measure |
Pembrolizumab, Paclitaxel + Carboplatin
n=26 Participants
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.
Pembrolizumab: Pembrolizumab on Day 1 of each cycle.
Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;
\- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.
Carboplatin: Carboplatin IV on Day 1 of each cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 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
|
1 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
|
24 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
|
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Participants who received at least one dose of pembrolizumab in combination with paclitaxel and carboplatin will have tissue collected at baseline and at the time interval debulking surgery (IDS).
The pORR will be calculated as the percentage of participants with pathologic complete response (pCR) and pathologic partial response (pPR) overall as best response. For this protocol, pathologic complete response (pCR) will be defined as no residual macroscopic or (viable) microscopic disease. Pathologic partial response (pPR) will be defined as the presence of residual (viable) microscopic tumor, and the size of the largest focus will be provided for possible outcome correlation.
Outcome measures
| Measure |
Pembrolizumab, Paclitaxel + Carboplatin
n=25 Participants
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.
Pembrolizumab: Pembrolizumab on Day 1 of each cycle.
Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;
\- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.
Carboplatin: Carboplatin IV on Day 1 of each cycle.
|
|---|---|
|
Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy
|
60 percentage of participants
Interval 38.7 to 78.9
|
SECONDARY outcome
Timeframe: Up to 48 monthsProgression-Free Survival (PFS) is measured from date of start of treatment to the earliest occurrence of any of the following events: documented disease progression or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status which is the date of last tumor assessment according to RECIST v1.1.
Outcome measures
| Measure |
Pembrolizumab, Paclitaxel + Carboplatin
n=26 Participants
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.
Pembrolizumab: Pembrolizumab on Day 1 of each cycle.
Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;
\- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.
Carboplatin: Carboplatin IV on Day 1 of each cycle.
|
|---|---|
|
Progression-Free Survival (PFS)
|
22.5 months
Interval 11.9 to
Insufficient number of participants with disease progression.
|
SECONDARY outcome
Timeframe: Up to 48 MonthsPopulation: All participants who received at least one dose of pembrolizumab in combination with paclitaxel and carboplatin.
Safety and tolerability of the intervention will be reported as the number of participants experiencing treatment-related toxicity including serious adverse events (SAEs) and adverse events (AEs), as assessed by treating physician. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0, per physician discretion.
Outcome measures
| Measure |
Pembrolizumab, Paclitaxel + Carboplatin
n=26 Participants
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.
Pembrolizumab: Pembrolizumab on Day 1 of each cycle.
Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;
\- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.
Carboplatin: Carboplatin IV on Day 1 of each cycle.
|
|---|---|
|
Number of Participants Experiencing Treatment-related Toxicity
All Treatment-related SAEs
|
3 Participants
|
|
Number of Participants Experiencing Treatment-related Toxicity
Grade 3 or higher treatment-related SAEs
|
1 Participants
|
|
Number of Participants Experiencing Treatment-related Toxicity
All Treatment-related AEs (excluding SAEs)
|
23 Participants
|
|
Number of Participants Experiencing Treatment-related Toxicity
Grade 3 or higher treatment-related AEs (excluding SAEs)
|
10 Participants
|
Adverse Events
Pembrolizumab, Paclitaxel + Carboplatin
Serious events: 6 serious events
Other events: 26 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Pembrolizumab, Paclitaxel + Carboplatin
n=26 participants at risk
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.
Pembrolizumab: Pembrolizumab on Day 1 of each cycle.
Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;
\- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.
Carboplatin: Carboplatin IV on Day 1 of each cycle.
|
|---|---|
|
Immune system disorders
Immune system disorder, other
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
General disorders
Non-cardiac chest pain
|
7.7%
2/26 • Number of events 2 • 48 months
|
|
Renal and urinary disorders
Urinary incontinence
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Renal and urinary disorders
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • 48 months
|
Other adverse events
| Measure |
Pembrolizumab, Paclitaxel + Carboplatin
n=26 participants at risk
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.
Pembrolizumab: Pembrolizumab on Day 1 of each cycle.
Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;
\- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.
Carboplatin: Carboplatin IV on Day 1 of each cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
34.6%
9/26 • Number of events 10 • 48 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Cardiac disorders
Atrial fibrillation
|
11.5%
3/26 • Number of events 4 • 48 months
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
2/26 • Number of events 2 • 48 months
|
|
Ear and labyrinth disorders
Ear pain
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Endocrine disorders
Hyperthyroidism
|
7.7%
2/26 • Number of events 2 • 48 months
|
|
Endocrine disorders
Hypothyroidism
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Eye disorders
Blurred vision
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Gastrointestinal disorders
Abdominal pain
|
26.9%
7/26 • Number of events 13 • 48 months
|
|
Gastrointestinal disorders
Ascites
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Gastrointestinal disorders
Bloating
|
11.5%
3/26 • Number of events 3 • 48 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Gastrointestinal disorders
Constipation
|
30.8%
8/26 • Number of events 8 • 48 months
|
|
Gastrointestinal disorders
Diarrhea
|
34.6%
9/26 • Number of events 9 • 48 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • Number of events 2 • 48 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.5%
3/26 • Number of events 3 • 48 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder, other
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
2/26 • Number of events 3 • 48 months
|
|
Gastrointestinal disorders
Nausea
|
53.8%
14/26 • Number of events 18 • 48 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Gastrointestinal disorders
Toothache
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
3/26 • Number of events 3 • 48 months
|
|
General disorders
Edema limbs
|
11.5%
3/26 • Number of events 3 • 48 months
|
|
General disorders
Fatigue
|
57.7%
15/26 • Number of events 21 • 48 months
|
|
General disorders
Fever
|
7.7%
2/26 • Number of events 2 • 48 months
|
|
General disorders
Flu like symptoms
|
7.7%
2/26 • Number of events 2 • 48 months
|
|
General disorders
Infusion site extravasation
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
General disorders
Pain
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Hepatobiliary disorders
Cholecystitis
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Infections and infestations
Infections and infestations - Other
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Infections and infestations
Papulopustular rash
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Infections and infestations
Upper respiratory infection
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Infections and infestations
Vaginal infection
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Injury, poisoning and procedural complications
Fracture
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
7.7%
2/26 • Number of events 3 • 48 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
3.8%
1/26 • Number of events 2 • 48 months
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
2/26 • Number of events 6 • 48 months
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
2/26 • Number of events 5 • 48 months
|
|
Investigations
Cholesterol high
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Investigations
Neutrophil count decreased
|
53.8%
14/26 • Number of events 24 • 48 months
|
|
Investigations
Platelet count decreased
|
15.4%
4/26 • Number of events 6 • 48 months
|
|
Investigations
White blood cell decreased
|
7.7%
2/26 • Number of events 2 • 48 months
|
|
Investigations
Anorexia
|
11.5%
3/26 • Number of events 3 • 48 months
|
|
Investigations
Hyperglycemia
|
11.5%
3/26 • Number of events 3 • 48 months
|
|
Investigations
Hyponatremia
|
3.8%
1/26 • Number of events 2 • 48 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.9%
7/26 • Number of events 9 • 48 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
4/26 • Number of events 4 • 48 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
19.2%
5/26 • Number of events 5 • 48 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Nervous system disorders
Cognitive disturbance
|
3.8%
1/26 • Number of events 2 • 48 months
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Number of events 3 • 48 months
|
|
Nervous system disorders
Dysgeusia
|
11.5%
3/26 • Number of events 3 • 48 months
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Number of events 4 • 48 months
|
|
Nervous system disorders
Neuralgia
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Nervous system disorders
Paresthesia
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
23.1%
6/26 • Number of events 6 • 48 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
38.5%
10/26 • Number of events 10 • 48 months
|
|
Nervous system disorders
Stroke
|
7.7%
2/26 • Number of events 2 • 48 months
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Number of events 3 • 48 months
|
|
Psychiatric disorders
Restlessness
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Renal and urinary disorders
Hematuria
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Renal and urinary disorders
Urinary frequency
|
7.7%
2/26 • Number of events 2 • 48 months
|
|
Renal and urinary disorders
Urinary incontinence
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Reproductive system and breast disorders
Breast pain
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Reproductive system and breast disorders
Vaginal pain
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.2%
5/26 • Number of events 5 • 48 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.2%
5/26 • Number of events 6 • 48 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
34.6%
9/26 • Number of events 15 • 48 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, other
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Vascular disorders
Flushing
|
3.8%
1/26 • Number of events 1 • 48 months
|
|
Vascular disorders
Hot flashes
|
11.5%
3/26 • Number of events 4 • 48 months
|
|
Vascular disorders
Thromboembolic event
|
7.7%
2/26 • Number of events 2 • 48 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place