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Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/Taxol/Pembro,Mainrtenance Olaparib/Pembro

Primary Purpose

Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
olaparibp, embro
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring newly diagnosed, stage III/IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid, carcinosarcoma, mixed Mullerian with high grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer. Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant setting with planned interval debulking surgery. Participant that is a candidate for neoadjuvant chemotherapy has a CA-125 (kilounits/L) : carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25 [Vergote, I., et al 2010]. Note: if the serum CA-125/CEA ratio is less than 25, then a workup should be negative for the presence of a non-ovarian cancer to determine eligibility (e.g., breast or gastrointestinal cancers [including CRC]). 5. Participant is female and at least 18 years of age on the day of signing informed consent. 6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to enrollment. 7. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow contraceptive guidance during the Treatment Period and for at least 120 days following the last dose of pembrolizumab and olaparib and at least 210 days following the last dose of chemotherapy 8. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research; however, the participant may participate in the main study without participating in future biomedical research. 9. Participant has adequate organ function as follows; all screening laboratory tests should be performed within 7 days of enrollment: Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Hemoglobin ≥8.0 g/dL or ≥5.6 mmol/L Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥51 mL/min for participant with creatinine levels >1.5 × institutional ULN Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) International normalized ratio (INR) OR prothrombin time (PT); Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Participant has mucinous, germ cell, or borderline tumor of the ovary. Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis. Participant either has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML. Participant has a known additional malignancy that is progressing or has required active treatment in the last 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded. Additionally, participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than I-A; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions. Participant has known active central nervous system metastases and/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to enrollment. Stable brain metastases should be established prior to the first dose of study medication. Note: Participants with known untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm) may participate but will require regular imaging of the brain as a site of disease. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg dailyof prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Participant has a known history of active tuberculosis (TB; Bacillus Tuberculosis). Participant has an active infection requiring systemic therapy. Participant is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Participant has had surgery to treat borderline tumors, early stage EOC, or fallopian tube cancer <6 months prior to screening. Participant has a known psychiatric or substance abuse disorder that would interfere with the ability to cooperate with the requirements of the study. Participant has a known history of human immunodeficiency virus (HIV) infection. Participant has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsag] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Participant has received prior treatment for advanced or metastatic OC, including radiation or systemic anti-cancer therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, investigational therapy). Participant has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, carboplatin, or paclitaxel, and/or any of their excipients. Participant has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation>500 ms, electrolyte disturbances, etc.), or participant has congenital long QT syndrome. Participant has had an allogenic tissue/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation. Participant has received prior therapy with olaparib or with any other PARP inhibitor. Participant has a known hypersensitivity to the components or excipients in olaparib. Participant is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 2 weeks. Participant is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents. Note: a current list of strong/moderate inducers of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers Participant has received a whole blood transfusion in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable if not performed within 28 days of the first dose of study intervention. Participant received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study intervention. Participant is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption). Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent. Participant has uncontrolled hypertension, defined as defined as systolic >140 mm Hg or diastolic >90 mm Hg documented by 2 blood pressure readings taken at least 1 hour apart. Note: This applies to participants who will receive bevacizumab. Use of antihypertensive medications to control blood pressure is allowed. Participant has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or gastrointestinal perforation, related to underlying EOC. Note: This applies to participants who will receive bevacizumab. Participant has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding within 6 months prior to enrollment Note: This applies only to participants who will receive bevacizumab. Participant is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of the first dose of study treatment. Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.

Sites / Locations

  • O'Neal Comprehensive Cancer Center at UAB

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carbo/taxol/pembro followed by maintenance of olaparib/pembro post-surgery

Arm Description

neoadjuvant carbo/taxol/pembro followed by maintenance olaparib/pembro post- surgery

Outcomes

Primary Outcome Measures

Progression free survival
Progression free survival at 36 month according to Response Evaluation Criteria in Solid tumors RECIST 1.1

Secondary Outcome Measures

Progression free survival at 12 months
To assess progression free survival at 12 months according to RECIST v1.1
Progression free survival at 24 months
To assess progression free survival at 24 months according to RECIST v1.1
pathological complete response (pCR)
To assess pathological complete response (pCR) at the time of interval debulking surgery after 3 cycles of therapy
overall survival (OS)
To assess overall survival (OS) at 36 months
Adverse events (CTCAE v5.0)
To assess safety and tolerability according to Common Terminology Criteria for adverse events (CTCAE v5.0) at 36 months

Full Information

First Posted
May 12, 2023
Last Updated
October 19, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05952453
Brief Title
Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/Taxol/Pembro,Mainrtenance Olaparib/Pembro
Official Title
A Phase II Study in Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer Evaluating Carbo/Taxol/Pembro in Patients Receiving Neoadjuvant Chemotherapy (NACT) Followed by Olaparib/Pembro Maintenance
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.
Detailed Description
This is a single-arm, phase II trial for patients with primary Stage III/IV advanced epithelial ovarian cancer who will receive neoadjuvant chemotherapy. All patients will receive a one-cycle lead-in of carboplatin (with or without) paclitaxel followed by three cycles of carboplatin, paclitaxel, and pembrolizumab prior to interval debulking surgery (IDS), and three cycles after IDS, followed by olaparib and pembrolizumab maintenance. Patients will receive a pre-treatment biopsy. The study will be done at 1 site and fresh tissue will be required pre-treatment as well as at the time of IDS. This tissue will be used for flow cytometry (to determine populations of cells - ie. Tregs, TILs, NK cells, MDSCs, DCs and other APCs), RNAseq (specifically looking at "hot" and "cold" signatures), proteomics (PD-L1 status and other protein expression), and immune score staining (based on the quantification of CD3 and CD8 both at the tumor center and the margins). The benefit of this study compared to other on-going upfront studies in ovarian cancer is that all patients will receive PARP inhibitor and pembrolizumab maintenance. Bevacizumab will be allowed after interval debulking surgery with the last 2 cycles of chemotherapy and can be continued as maintenance in these patients. Additionally, if a patient does not have a CR at the conclusion of their chemotherapy, bevacizumab can be added during the maintenance period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
newly diagnosed, stage III/IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
single- arm phase II trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carbo/taxol/pembro followed by maintenance of olaparib/pembro post-surgery
Arm Type
Experimental
Arm Description
neoadjuvant carbo/taxol/pembro followed by maintenance olaparib/pembro post- surgery
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
pembrolizimab, taxol
Intervention Description
neoadjuvant treatment , followed by surgery, then maintenance chemotherapy
Intervention Type
Drug
Intervention Name(s)
olaparibp, embro
Intervention Description
maintenance chemotherapy : olaparib, pembro
Primary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival at 36 month according to Response Evaluation Criteria in Solid tumors RECIST 1.1
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Progression free survival at 12 months
Description
To assess progression free survival at 12 months according to RECIST v1.1
Time Frame
12 months
Title
Progression free survival at 24 months
Description
To assess progression free survival at 24 months according to RECIST v1.1
Time Frame
24 months
Title
pathological complete response (pCR)
Description
To assess pathological complete response (pCR) at the time of interval debulking surgery after 3 cycles of therapy
Time Frame
12-20 weeks
Title
overall survival (OS)
Description
To assess overall survival (OS) at 36 months
Time Frame
36 months
Title
Adverse events (CTCAE v5.0)
Description
To assess safety and tolerability according to Common Terminology Criteria for adverse events (CTCAE v5.0) at 36 months
Time Frame
36 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid, carcinosarcoma, mixed Mullerian with high grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer. Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant setting with planned interval debulking surgery. Participant that is a candidate for neoadjuvant chemotherapy has a CA-125 (kilounits/L) : carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25 [Vergote, I., et al 2010]. Note: if the serum CA-125/CEA ratio is less than 25, then a workup should be negative for the presence of a non-ovarian cancer to determine eligibility (e.g., breast or gastrointestinal cancers [including CRC]). 5. Participant is female and at least 18 years of age on the day of signing informed consent. 6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to enrollment. 7. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow contraceptive guidance during the Treatment Period and for at least 120 days following the last dose of pembrolizumab and olaparib and at least 210 days following the last dose of chemotherapy 8. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research; however, the participant may participate in the main study without participating in future biomedical research. 9. Participant has adequate organ function as follows; all screening laboratory tests should be performed within 7 days of enrollment: Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Hemoglobin ≥8.0 g/dL or ≥5.6 mmol/L Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥51 mL/min for participant with creatinine levels >1.5 × institutional ULN Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) International normalized ratio (INR) OR prothrombin time (PT); Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Participant has mucinous, germ cell, or borderline tumor of the ovary. Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis. Participant either has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML. Participant has a known additional malignancy that is progressing or has required active treatment in the last 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded. Additionally, participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than I-A; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions. Participant has known active central nervous system metastases and/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to enrollment. Stable brain metastases should be established prior to the first dose of study medication. Note: Participants with known untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm) may participate but will require regular imaging of the brain as a site of disease. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg dailyof prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Participant has a known history of active tuberculosis (TB; Bacillus Tuberculosis). Participant has an active infection requiring systemic therapy. Participant is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Participant has had surgery to treat borderline tumors, early stage EOC, or fallopian tube cancer <6 months prior to screening. Participant has a known psychiatric or substance abuse disorder that would interfere with the ability to cooperate with the requirements of the study. Participant has a known history of human immunodeficiency virus (HIV) infection. Participant has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsag] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Participant has received prior treatment for advanced or metastatic OC, including radiation or systemic anti-cancer therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, investigational therapy). Participant has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, carboplatin, or paclitaxel, and/or any of their excipients. Participant has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation>500 ms, electrolyte disturbances, etc.), or participant has congenital long QT syndrome. Participant has had an allogenic tissue/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation. Participant has received prior therapy with olaparib or with any other PARP inhibitor. Participant has a known hypersensitivity to the components or excipients in olaparib. Participant is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 2 weeks. Participant is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents. Note: a current list of strong/moderate inducers of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers Participant has received a whole blood transfusion in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable if not performed within 28 days of the first dose of study intervention. Participant received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study intervention. Participant is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption). Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent. Participant has uncontrolled hypertension, defined as defined as systolic >140 mm Hg or diastolic >90 mm Hg documented by 2 blood pressure readings taken at least 1 hour apart. Note: This applies to participants who will receive bevacizumab. Use of antihypertensive medications to control blood pressure is allowed. Participant has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or gastrointestinal perforation, related to underlying EOC. Note: This applies to participants who will receive bevacizumab. Participant has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding within 6 months prior to enrollment Note: This applies only to participants who will receive bevacizumab. Participant is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of the first dose of study treatment. Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Hyde
Phone
(205) 934-1704
Email
jspratlin@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela M Hardwick
Phone
2059755387
Email
pamdixon@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Arend
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
O'Neal Comprehensive Cancer Center at UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Hardwick, RN
Phone
205-975-5387
Email
pamdixon@uab.edu
First Name & Middle Initial & Last Name & Degree
Rebecca Arend, MD, MSPH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/Taxol/Pembro,Mainrtenance Olaparib/Pembro

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