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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03976362
Registration number
NCT03976362
Ethics application status
Date submitted
3/06/2019
Date registered
6/06/2019
Titles & IDs
Public title
A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
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Scientific title
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
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Secondary ID [1]
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MK-7339-008
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Secondary ID [2]
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7339-008
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Squamous Cell, Non-small-cell Lung
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Olaparib
Treatment: Drugs - Placebo
Experimental: Pembrolizumab + Carboplatin + Taxane + Olaparib - For the Induction Phase, participants receive 4 cycles:
Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.
For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Active comparator: Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo - For the Induction Phase, participants receive 4 cycles:
Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.
For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Treatment: Other: Pembrolizumab
IV infusion
Treatment: Drugs: Carboplatin
IV infusion
Treatment: Drugs: Paclitaxel
IV infusion
Treatment: Drugs: Nab-paclitaxel
IV infusion
Treatment: Drugs: Olaparib
Tablets
Treatment: Drugs: Placebo
Placebo to olaparib, tablets
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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Assessment method [1]
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Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to approximately 3 years
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival is the time from the date of randomization to death due to any cause.
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Timepoint [2]
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Up to approximately 4 years
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Secondary outcome [1]
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Number of Participants With One or More Adverse Events (AEs)
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Assessment method [1]
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An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Number of participants discontinuing study intervention due to adverse events (AEs)
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Assessment method [2]
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An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [3]
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Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score
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Assessment method [3]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
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Timepoint [3]
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Baseline (at randomization) and Week 18 post-randomization
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Secondary outcome [4]
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Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
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Assessment method [4]
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The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
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Timepoint [4]
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Baseline (at randomization) and Week 18 post-randomization
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Secondary outcome [5]
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Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
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Assessment method [5]
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The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
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Timepoint [5]
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Baseline (at randomization) and Week 18 post-randomization
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Secondary outcome [6]
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Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
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Assessment method [6]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome.
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Timepoint [6]
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Baseline (at randomization) and Week 18 post-randomization
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Secondary outcome [7]
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Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
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Assessment method [7]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
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Timepoint [7]
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Baseline (at randomization) and Week 18 post-randomization
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Secondary outcome [8]
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Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score
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Assessment method [8]
0
0
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in Items 29 and 30 scale scores.
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Timepoint [8]
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Up to approximately 5 years
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Secondary outcome [9]
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Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
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Assessment method [9]
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The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in cough scale score.
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Timepoint [9]
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Up to approximately 5 years
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Secondary outcome [10]
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Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
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Assessment method [10]
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0
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in chest pain scale score.
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Timepoint [10]
0
0
Up to approximately 5 years
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Secondary outcome [11]
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Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
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Assessment method [11]
0
0
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in Item 8 scale score.
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Timepoint [11]
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0
Up to approximately 5 years
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Secondary outcome [12]
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Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
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Assessment method [12]
0
0
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in physical functioning Items 1 to 5 scale scores.
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Timepoint [12]
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Up to approximately 5 years
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Eligibility
Key inclusion criteria
1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
2. Have Stage IV squamous NSCLC.
3. Have measurable disease based on RECIST 1.1.
4. Have not received prior systemic treatment for their advanced/metastatic NSCLC.
5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
7. Have a life expectancy of at least 3 months.
8. Has adequate organ function.
9. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
10. Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Has non-squamous histology NSCLC.
2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
3. Has known active central nervous system metastases and/or carcinomatous meningitis.
4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
5. Has a severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
6. Has an active autoimmune disease that has required systemic treatment in past 2 years.
7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/06/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
12/03/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
591
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Liverpool Hospital ( Site 1201) - Liverpool
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Recruitment hospital [2]
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Southern Medical Day Care Centre ( Site 1200) - Wollongong
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Recruitment hospital [3]
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Townsville General Hospital ( Site 1202) - Townsville
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Recruitment hospital [4]
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Monash Cancer Centre ( Site 1205) - Clayton
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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4814 - Townsville
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Illinois
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Indiana
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Washington
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Buenos Aires
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Argentina
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Caba
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Santa Fe
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Para
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Tokyo
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Baja California Sur
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Country [65]
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0
Mexico
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State/province [65]
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Jalisco
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Mexico
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Nuevo Leon
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Country [67]
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Mexico
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Veracruz
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Country [68]
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Mexico
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Cdmx
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New Zealand
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Manawatu-Wanganui
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New Zealand
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Wellington
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Poland
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Dolnoslaskie
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Poland
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Malopolskie
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Poland
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Mazowieckie
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Poland
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Slaskie
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Poland
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Wielkopolskie
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Romania
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State/province [76]
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Cluj
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Romania
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Dolj
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Romania
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Timis
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Romania
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Bucuresti
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Country [80]
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Romania
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Constanta
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Country [81]
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Russian Federation
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State/province [81]
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Moskovskaya Oblast
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Country [82]
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Russian Federation
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State/province [82]
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Moskva
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Russian Federation
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Nizhegorodskaya Oblast
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Russian Federation
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State/province [84]
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Omskaya Oblast
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Russian Federation
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Samarskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Tatarstan, Respublika
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Spain
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Barcelona
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Malaga
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Spain
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State/province [92]
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Sevilla
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Country [93]
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Taiwan
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State/province [93]
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Kaohsiung
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Taiwan
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State/province [94]
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Taichung
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Country [95]
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Taiwan
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State/province [95]
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Tainan
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Country [96]
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Taiwan
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State/province [96]
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Taipei
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Country [97]
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Taiwan
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State/province [97]
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Taoyuan
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Country [98]
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Turkey
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State/province [98]
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Tekirdas
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Country [99]
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Turkey
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Adana
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Turkey
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State/province [100]
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Ankara
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Country [101]
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Turkey
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State/province [101]
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Istanbul
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Country [102]
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Turkey
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State/province [102]
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Izmir
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Country [103]
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Turkey
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State/province [103]
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Kayseri
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Country [104]
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Turkey
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State/province [104]
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Samsun
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Country [105]
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Ukraine
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State/province [105]
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Cherkaska Oblast
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Country [106]
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Ukraine
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State/province [106]
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Dnipropetrovska Oblast
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Country [107]
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Ukraine
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State/province [107]
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Ivano-Frankivska Oblast
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Country [108]
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Ukraine
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State/province [108]
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Kharkivska Oblast
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Country [109]
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Ukraine
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State/province [109]
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Kirovohradska Oblast
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Ukraine
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State/province [110]
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Kyivska Oblast
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Ukraine
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State/province [111]
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Odeska Oblast
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Country [112]
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Ukraine
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State/province [112]
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Zakarpatska Oblast
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Country [113]
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Ukraine
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Kyiv
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Country [114]
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United Kingdom
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State/province [114]
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Essex
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Country [115]
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United Kingdom
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State/province [115]
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London, City Of
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Country [116]
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United Kingdom
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State/province [116]
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Newcastle Upon Tyne
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Country [117]
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United Kingdom
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State/province [117]
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Suffolk
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Country [118]
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United Kingdom
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State/province [118]
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Wales
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Country [119]
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United Kingdom
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State/province [119]
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Worcestershire
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Country [120]
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United Kingdom
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State/province [120]
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Birmingham
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Country [121]
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United Kingdom
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State/province [121]
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Edinburg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
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Trial website
https://clinicaltrials.gov/study/NCT03976362
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Email
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03976362