A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
PRIMARY OBJECTIVE:
I. To determine investigator assessed progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (non-inferiority) for one versus (vs.) two years of maintenance olaparib.
SECONDARY OBJECTIVES:
I. To evaluate overall survival (OS360) in the modified intent to treat (ITT) population, with time at risk for progression/death starting 360 days after randomization.
II. To evaluate progression-free survival (PFS), PFS2 and overall survival (OS) in the ITT population.
III. To evaluate PFS, PFS2, and OS in the as-treated population. IV. To evaluate toxicity, including rates of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and other secondary malignancies, in the safety population.
EXPLORATORY OBJECTIVE:
I. To evaluate the moderating effect of physician-choice bevacizumab (as stratified) on randomized treatment effect estimates.
TRANSLATIONAL OBJECTIVES:
I. To assess BRCA reversion mutations in circulating tumor deoxyribonucleic acid (ctDNA) as a predictor of poor response in the BRCA mutated (BRCAm) population.
II. To correlate a combined assay assessing quantitative BRCA1 and RAD51C promoter methylation and pathogenic variants in core homologous recombination repair (HRR) genes with clinical homologous recombination deficiency (HRD) testing and outcomes in the BRCA wildtype (BRCAwt) population.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (REFERENCE): Patients receive olaparib orally (PO) twice daily (BID) on days 1-21 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study.
ARM II (EXPERIMENTAL): Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years.
Inclusion Criteria:
Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:
Patients must have:
Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)
BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©)
Patient must have undergone cytoreductive surgery (primary or interval)
Patients must have completed first line platinum-based therapy prior to registration:
Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated
Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle
Patients must not have received an investigational agent during their first line course of chemotherapy
Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression and patients are neurologically stable off steroid therapy
Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent)
No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Not pregnant and not nursing
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
Platelets ≥ 100,000 cells/mm^3
Hemoglobin ≥ 9 g/dl
Creatinine clearance (CrCL) of > 30 mL/min by the Cockcroft-Gault formula
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
No active infection requiring parental antibiotic(s)
No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
No current inability to swallow orally administered medication
No history of myelodysplastic syndrome and/or acute myeloid leukemia
No history of allogeneic bone marrow transplant
No concomitant use of strong or moderate CYP3A inducers
No known hypersensitivity to olaparib or any of the excipients of the product
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CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
218-365-7900
CancerTrials@EssentiaHealth.org218-786-3308
218-786-3308
218-283-9431
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1572
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
OncRegulatory@avera.org605-322-3095
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
612-624-2620
mmcorc@healthpartners.com952-993-1517
218-485-4481
mmcorc@healthpartners.com952-993-1517
CancerTrials@EssentiaHealth.org218-786-3308
218-568-4416
218-587-4416
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
855-776-0015
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
CancerTrials@EssentiaHealth.org218-786-3308
mmcorc@healthpartners.com952-993-1517
218-894-7870
mmcorc@healthpartners.com952-993-1517
CancerTrials@EssentiaHealth.org218-786-3308
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
888-446-3729
aroland@kccop.org913-948-5588
417-269-4520
888-446-3729
sfmc@sfmc.net573-334-2230
573-882-7440
314-996-5569
LJCrockett@freemanhealth.com417-347-4030
esmeralda.carrillo@mercy.net417-556-3074
clinicaltrials@lakeregional.com573-302-2768
573-458-6379
research@phelpshealth.org573-458-7504
Trisha.England2@mymlc.com816-271-7937
314-996-5569
417-269-4520
417-269-4520
888-446-3729
info@siteman.wustl.edu800-600-3606
Danielle.Werle@mercy.net314-525-6042
314-996-5569
314-251-7066
314-996-5569
636-390-1600
mccinfo@mtcancer.org406-969-6060
research@billingsclinic.org800-996-2663
mccinfo@mtcancer.org406-969-6060
800-648-6274
406-238-6685
mccinfo@mtcancer.org406-969-6060
406-723-2621
mccinfo@mtcancer.org406-969-6060
mccinfo@mtcancer.org406-969-6060
Roster@nrgoncology.org412-339-5294
mccinfo@mtcancer.org406-969-6060
mccinfo@mtcancer.org406-969-6060
amy.hanneman@providence.org406-327-3118
mccinfo@mtcancer.org406-969-6060
unmcrsa@unmc.edu402-559-6941
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
unmcrsa@unmc.edu402-559-6941
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
402-334-4773
402-354-5144
402-559-5600
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
unmcrsa@unmc.edu402-559-6941
702-851-4672
212-639-7592
Roster@nrgoncology.org412-339-5294
856-325-6757
mmackenzie@summithealth.com
609-631-6946
Roster@nrgoncology.org412-339-5294
973-322-5200
212-639-7592
212-639-7592
732-235-7356
ONCTrialNow@jefferson.edu215-600-9151
Siby.Varughese@rwjbh.org908-685-2481
HSC-ClinicalTrialInfo@salud.unm.edu505-925-0348
david.wallach@nyulangone.org646-754-4624
212-639-7592
212-639-7592
cancertrials@nyulangone.org212-263-4432
CCTO@mssm.edu212-824-7309
david.wallach@nyulangone.org646-754-4624
CancerTrials@nyulangone.org
CCTO@mssm.edu212-824-7309
CCTO@mssm.edu212-824-7309
212-639-7592
585-275-5830
315-464-5476
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WCICTOresearch@urmc.rochester.edu
cancerclinicaltrials@med.unc.edu877-668-0683
888-275-3853
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CancerTrials@EssentiaHealth.org218-786-3308
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CancerTrials@EssentiaHealth.org218-786-3308
Jennifer.Sexton@ohiohealth.com614-788-3860
CTUReferral@UHhospitals.org800-641-2422
CTUReferral@UHhospitals.org800-641-2422
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
CTUReferral@UHhospitals.org800-641-2422
TaussigResearch@ccf.org866-223-8100
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Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
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Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
Jennifer.Sexton@ohiohealth.com614-788-3860
TaussigResearch@ccf.org866-223-8100
CTUReferral@UHhospitals.org800-641-2422
CTUReferral@UHhospitals.org800-641-2422
Jennifer.Sexton@ohiohealth.com614-788-3860
PCIOncResearch@promedica.org419-824-1842
PCIOncResearch@promedica.org419-824-1842
Jennifer.Sexton@ohiohealth.com610-788-3860
CTUReferral@UHhospitals.org800-641-2422
ou-clinical-trials@ouhsc.edu405-271-8777
405-752-3402
mccinfo@mtcancer.org406-969-6060
nosall@stcharleshealthcare.org541-706-2909
CanRsrchStudies@providence.org503-215-2614
cherie.cox@bayareahospital.org541-269-8392
canrsrchstudies@provdience.org503-215-1979
CanRsrchStudies@providence.org503-215-2614
mccinfo@mtcancer.org406-969-6060
CanRsrchStudies@providence.org503-215-2614
cancer@lhs.org800-220-4937
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
trials@ohsu.edu503-494-1080
541-706-2909
503-413-1742
Morgan_M.Horton@lvhn.org610-402-9543
610-776-4714
484-503-4151
Morgan_M.Horton@lvhn.org610-402-9543
lbarone@christianacare.org302-623-4450
Roster@nrgoncology.org412-339-5294
Morgan_M.Horton@lvhn.org610-402-9543
Roster@nrgoncology.org412-339-5294
717-721-4840
877-441-7957
717-632-1559
Morgan_M.Horton@lvhn.org610-402-9543
CTO@hmc.psu.edu717-531-3779
doxenberg@wellspan.org717-741-8303
PMCancerResearch@pennmedicine.upenn.edu215-349-8245
PMCancerResearch@pennmedicine.upenn.edu215-349-8245
ONCTrialNow@jefferson.edu215-600-9151
ONCTrialNow@jefferson.edu215-600-9151
610-776-4714
Roster@nrgoncology.org412-339-5294
PMCancerResearch@pennmedicine.upenn.edu215-349-8245
ONCTrialNow@jefferson.edu215-600-9151
877-441-7957
877-441-7957
401-274-1122
kmertz-rivera@gibbscc.org864-560-6104
kmertz-rivera@gibbscc.org864-560-6104
kmertz-rivera@gibbscc.org864-560-6104
kmertz-rivera@gibbscc.org864-560-6104
oncregulatory@avera.org605-622-8700
OncRegulatory@avera.org605-322-3096
OncRegulatory@avera.org605-322-3095
OncologyClinicTrialsSF@sanfordhealth.org605-312-3320
OncRegulatory@avera.org605-322-3095
OncologyClinicalTrialsSF@SanfordHealth.org605-312-3320
OncRegulatory@avera.org605-655-1800
800-811-8480
800-811-8480
800-811-8480
800-811-8480
canceranswerline@UTSouthwestern.edu214-590-5582
canceranswerline@UTSouthwestern.edu214-648-7097
canceranswerline@UTSouthwestern.edu214-648-7097
713-790-2700
713-792-3245
Roster@nrgoncology.org412-339-5294
832-522-2873
Roster@nrgoncology.org412-339-5294
Suzanne.cole@utsouthwestern.edu972-669-7044
hmthewoodlands@houstonmethodist.org713-790-2700
cancerinfo@hci.utah.edu888-424-2100
cancerinfo@hci.utah.edu888-424-2100
cancerinfo@hci.utah.edu888-424-2100
uvacancertrials@hscmail.mcc.virginia.edu434-243-6303
CTOclinops@vcu.edu804-628-6430
deidre.dillon@providence.org360-412-8958
achapman1@peacehealth.org360-788-8223
deidre.dillon@providence.org360-412-8958
PCRC-NCORP@Swedish.org206-215-2343
marilyn.birchman@providence.org425-261-3529
PCRC-NCORP@Swedish.org206-215-2343
research@kadlecmed.org509-783-4637
deidre.dillon@providence.org360-412-8958
kmakin-bond@peacehealth.org360-514-2016
rcccclinicalresearch@skagitvalleyhospital.org360-814-2182
PCRC-NCORP@Swedish.org206-215-3086
800-804-8824
PCRC-NCORP@Swedish.org206-215-3086
PCRC-NCORP@Swedish.org206-215-2343
800-804-8824
800-804-8824
achapman1@peacehealth.org360-788-8239
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
research@ccnw.net509-228-1680
research@ccnw.net509-228-1680
research@ccnw.net509-228-1680
503-413-2150
Cheryl.Dodd@providence.org509-897-5993
cancertrialsinfo@hsc.wvu.edu304-293-7374
cancertrialsinfo@hsc.wvu.edu304-293-7374
cancertrialsinfo@hsc.wvu.edu304-293-7374
cancertrialsinfo@hsc.wvu.edu304-293-7374
304-487-7515
304-243-6442
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
WI_research_admin@hshs.org920-433-8889
wi_research_admin@hshs.org920-433-8889
ncorp@aurora.org414-302-2304
CancerTrials@EssentiaHealth.org218-786-3308
218-568-4416
ncorp@aurora.org414-302-2304
cancerctr@gundersenhealth.org608-775-2385
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
414-805-3666
ncorp@aurora.org414-302-2304
research.institute@phci.org
mmcorc@healthpartners.com952-993-1517
262-928-7878
WI_research_admin@hshs.org920-433-8889
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
wi_research_admin@hshs.org920-433-8889
wi_research_admin@hshs.org920-433-8889
ncorp@aurora.org414-302-2304
CancerTrials@EssentiaHealth.org218-786-3308
wi_research_admin@hshs.org920-433-8889
701-364-6272
ncorp@aurora.org414-302-2304
262-928-7632
Chanda.miller@phci.org262-928-5539
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
Roster@nrgoncology.org412-339-5294
research@billingsclinic.org800-996-2663
med-som@bureau.tohoku.ac.jp
(081) 089-964-5111
(0823) 22-3111
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011 81 099 224 2101
Roster@nrgoncology.org412-339-5294
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Roster@nrgoncology.org412-339-5294
info@PRoncology.com787-919-7919
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