Trial Outcomes & Findings for Pembrolizumab and Olaparib in Cervical Cancer Patients (NCT NCT04483544)
NCT ID: NCT04483544
Last Updated: 2025-04-29
Results Overview
Overall objective Response Rate by Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria (iORR)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
3 years
Results posted on
2025-04-29
Participant Flow
Participant milestones
| Measure |
Treatment
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Screening
STARTED
|
8
|
|
Screening
COMPLETED
|
8
|
|
Screening
NOT COMPLETED
|
0
|
|
Treatment (Completed 1 or More Cycles)
STARTED
|
8
|
|
Treatment (Completed 1 or More Cycles)
COMPLETED
|
7
|
|
Treatment (Completed 1 or More Cycles)
NOT COMPLETED
|
1
|
|
End of Treatment
STARTED
|
7
|
|
End of Treatment
COMPLETED
|
7
|
|
End of Treatment
NOT COMPLETED
|
0
|
|
Post-Treatment
STARTED
|
7
|
|
Post-Treatment
COMPLETED
|
2
|
|
Post-Treatment
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Treatment (Completed 1 or More Cycles)
Death
|
1
|
|
Post-Treatment
Admitted to hospice
|
2
|
|
Post-Treatment
Study terminated
|
3
|
Baseline Characteristics
Pembrolizumab and Olaparib in Cervical Cancer Patients
Baseline characteristics by cohort
| Measure |
Treatment
n=8 Participants
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 7.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 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
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOverall objective Response Rate by Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria (iORR)
Outcome measures
| Measure |
Treatment
n=8 Participants
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Immune Overall Response Rate
|
16.7 percent of participants
Interval 8.8 to 19.1
|
SECONDARY outcome
Timeframe: 3 yearsDefined among all treated patients as the time from first dose of study drug until the first date of either disease progression or death due to any cause
Outcome measures
| Measure |
Treatment
n=8 Participants
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Progression Free Survival
|
4.5 months
Interval 2.0 to
Upper bound was not reached for time to event analysis due to lack of enough events observed in the study population by the end of follow-up. Specifically, due to small sample size to start, compounded by censoring of data, many patients did not have the event. Therefore, the upper bound of the 95% confidence interval could not be calculated.
|
SECONDARY outcome
Timeframe: 3 yearsThe number of patients reporting treatment emergent adverse events (TEAEs) defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study
Outcome measures
| Measure |
Treatment
n=8 Participants
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Number of Patient Reporting Treatment-emergent Adverse Events (TEAEs)
|
8 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: The planned Fanconi Anemia Triple Stain Immunofluorescence assay could not be completed due to lack of available resources to conduct the assay.
The number of patients with baseline tumor deficiencies in the Fanconi Anemia pathway associated with antitumor responses to the combination as assessed by the Fanconi Anemia Triple Stain Immunofluorescence assay, performed on archived paraffin embedded tumor tissues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: There were not enough data available to analyze duration of response statistically. Only two participants had partial response and none had complete response. Of the two, only one participant had progression so duration of response could be calculated. The other participant did not progress. Duration of response is presented for the one participant.
Duration of response (DoR), defined as time from documentation of tumor response to disease progression
Outcome measures
| Measure |
Treatment
n=1 Participants
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Duration of Response
|
62 days
Standard Deviation 0
|
Adverse Events
Treatment
Serious events: 6 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment
n=8 participants at risk
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Infections and infestations
Infections and Infestations - Other, Abscess
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Infections and infestations
Kidney Infection
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Infections and infestations
Sepsis
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Investigations
Creatinine Increased
|
37.5%
3/8 • Number of events 3 • 3 years
|
|
Investigations
Platelet Count Decreased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Vascular disorders
Stroke
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
1/8 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Treatment
n=8 participants at risk
PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib
pembrolizumab: PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
olaparib: PARP inhibitor olaparib 300 mg orally, twice daily (BID)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
6/8 • Number of events 28 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Eye disorders
Blurred Vision
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
2/8 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Colonic Obstruction
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
37.5%
3/8 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Hematochezia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Rectal Ulcer
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 6 • 3 years
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 6 • 3 years
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 2 • 3 years
|
|
Infections and infestations
Kidney Infection
|
12.5%
1/8 • Number of events 2 • 3 years
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Infections and infestations
Skin Infection
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Infections and infestations
Urinary Tract Infection
|
50.0%
4/8 • Number of events 10 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
2/8 • Number of events 4 • 3 years
|
|
Investigations
Creatinine Increased
|
37.5%
3/8 • Number of events 7 • 3 years
|
|
Investigations
Neutrophil Count Decreased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Investigations
Platelet Count Decreased
|
37.5%
3/8 • Number of events 4 • 3 years
|
|
Investigations
Thyroid Stimulating Hormone Increased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
37.5%
3/8 • Number of events 4 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
2/8 • Number of events 3 • 3 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
12.5%
1/8 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
37.5%
3/8 • Number of events 8 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
4/8 • Number of events 13 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
3/8 • Number of events 10 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
37.5%
3/8 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
37.5%
3/8 • Number of events 4 • 3 years
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
37.5%
3/8 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Disorders - Other, Rash Not Otherwise Specified
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 1 • 3 years
|
Additional Information
Director, Research Concept & Protocol Development
Miami Cancer Institute at Baptist Health, Inc.
Phone: (786) 527-9546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place