Trial Outcomes & Findings for Pembrolizumab, Bevacizumab, and Cyclophosphamide in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT02853318)
NCT ID: NCT02853318
Last Updated: 2021-10-06
Results Overview
The highest observed adverse event will be tabulated by grade across all dose levels and cycles.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2021-10-06
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Cyclophosphamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Cyclophosphamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pembrolizumab, Bevacizumab, and Cyclophosphamide in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
n=40 Participants
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Cyclophosphamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
|
ECOG Performance Status
0
|
28 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
12 Participants
n=5 Participants
|
|
BRCA mutation status
positive
|
14 Participants
n=5 Participants
|
|
BRCA mutation status
negative
|
23 Participants
n=5 Participants
|
|
BRCA mutation status
unknown
|
3 Participants
n=5 Participants
|
|
Baseline PDL1 expression
positive
|
19 Participants
n=5 Participants
|
|
Baseline PDL1 expression
negative
|
17 Participants
n=5 Participants
|
|
Baseline PDL1 expression
unknown
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearThe highest observed adverse event will be tabulated by grade across all dose levels and cycles.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
n=40 Participants
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Cyclophosphamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events
No Adverse Events
|
1 Participants
|
|
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events
Grade I
|
9 Participants
|
|
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events
Grade II
|
20 Participants
|
|
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events
Grade III
|
9 Participants
|
|
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events
Grade IV
|
1 Participants
|
|
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events
Grade V
|
0 Participants
|
PRIMARY outcome
Timeframe: Time from the start of the study treatment until PFS event, assessed up to 1 year after the last subject enrollsWill be summarized using standard Kaplan-Meier methods, with estimates of median survival and given survival rates will be obtained with 90% confidence intervals.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
n=40 Participants
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Cyclophosphamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
|
10.0 months
Interval 6.5 to 17.4
|
SECONDARY outcome
Timeframe: Up to 1 year after enrollment of the last subjectWill be summarized using standard Kaplan-Meier methods, with estimates of median survival and given survival rates will be obtained with 90% confidence intervals.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
n=40 Participants
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Cyclophosphamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Duration of Overall Survival
|
16.0 months
Interval 12.5 to 26.1
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The IHC, Nannostring, Flow Cytometry and Luminex assays were not completed.
Assessed with immunohistochemistry (IHC), Nannostring, Flow Cytometry and Luminex assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 months after enrollment start of treatmentFrequency of response will be summarized with a 90% confidence interval. An objective response is defined as a CR or PR, while a non-responder is defined as a SD or PD.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
n=40 Participants
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Cyclophosphamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Objective Tumor Response Assessed by Modified RECIST Version 1.1 Criteria
|
0.475 proportion of participants
Interval 0.349 to 0.603
|
Adverse Events
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
Serious events: 0 serious events
Other events: 38 other events
Deaths: 27 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)
n=40 participants at risk
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Cyclophosphamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
4/40 • Number of events 4 • Adverse Events: Through study completion up to 3 years.
|
|
Eye disorders
Eye pruritus
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.5%
3/40 • Number of events 3 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.0%
14/40 • Number of events 20 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Loose tooth
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
22.5%
9/40 • Number of events 10 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Stomatitis
|
7.5%
3/40 • Number of events 3 • Adverse Events: Through study completion up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
5/40 • Number of events 5 • Adverse Events: Through study completion up to 3 years.
|
|
General disorders
Fatigue
|
40.0%
16/40 • Number of events 20 • Adverse Events: Through study completion up to 3 years.
|
|
General disorders
Feeling cold
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
General disorders
Influenza like illness
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
General disorders
Mucosal inflammation
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
General disorders
Pain
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Infections and infestations
Bronchitis
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Infections and infestations
Vaginal infection
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
5/40 • Number of events 7 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Blood creatine increased
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Blood creatinine increased
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Lymphocyte count decreased
|
17.5%
7/40 • Number of events 11 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Platelet count decreased
|
5.0%
2/40 • Number of events 4 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Urine analysis abnormal
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Urine protein/creatinine ratio increased
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
Weight decreased
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Investigations
White blood cell count decreased
|
12.5%
5/40 • Number of events 8 • Adverse Events: Through study completion up to 3 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.5%
9/40 • Number of events 11 • Adverse Events: Through study completion up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.5%
3/40 • Number of events 3 • Adverse Events: Through study completion up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
5/40 • Number of events 5 • Adverse Events: Through study completion up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Nervous system disorders
Encephalopathy
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Nervous system disorders
Taste disorder
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Number of events 3 • Adverse Events: Through study completion up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
4/40 • Number of events 4 • Adverse Events: Through study completion up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
3/40 • Number of events 5 • Adverse Events: Through study completion up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
2/40 • Number of events 2 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
3/40 • Number of events 3 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.5%
1/40 • Number of events 1 • Adverse Events: Through study completion up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
5/40 • Number of events 5 • Adverse Events: Through study completion up to 3 years.
|
|
Vascular disorders
Hypertension
|
35.0%
14/40 • Number of events 22 • Adverse Events: Through study completion up to 3 years.
|
Additional Information
Katy Wang, Statistician, M.A.
Roswell Park Comprehensive Cancer Institute
Phone: 7168451300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place