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Comparator: 18-F-FDG PET/CT and Volumetric CT

Phase 1

Ovarian Cancer | Unknown | Oncology |Merck & Company, Inc.|Last Updated: Jan 22, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00959582Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)PHASE1 COMPLETED 42Sep 1, 2009Oct 1, 2011Jan 22, 2015 -
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Study Endpoints
Primary Endpoints
Proportion of patients with metabolic non-response assessed by FDG-PET standardized uptake value (SUV) 3 weeks and 6 weeks after starting platinum-based therapy
Baseline, Week 3, Week 6
Progression free proportion
40 Weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL18-F-FDG PET/CT imaging
Interventions
NameTypeDescription
Comparator: 18-F-FDG PET/CT and Volumetric CTPROCEDUREPatients will receive standard-of-care therapy (carboplatin or cisplatin monotherapy, or a two-drug combination where one is platinum). FDG-PET/CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, and if patients are progression-free at the end of Cycle 6. Volumetric CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, after Cycle 3 of chemotherapy (optional), and if patients are progression-free at the end of Cycle 6 and at 40 weeks after Cycle 1 dosing.
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Eligibility Criteria
Age Range35 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Patient has ovarian, primary peritoneal, or fallopian tube cancer * Patient has first or subsequent relapse * Patient has had at least on prior platinum-based treatment for ovarian cancer * Patient is scheduled to receive treatment with carboplatin or cisplatin monotherapy or ...

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Competitive Landscape -Ovarian Cancer 180 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel, Sacituzumab tirumotecan
AstraZeneca PLCAZN19PHASE3Olaparib, Bevacizumab, Durvalumab, Carboplatin+Paclitaxel, AZD5335
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab, Mirvetuximab soravtansine, Carboplatin, Mirvetuximab Soravtansine
GSK plc Sponsored ADRGSK4PHASE3Niraparib, Dostarlimab, Mocertatug rezetecan, Paclitaxel, Pegylated liposomal doxorubicin
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab, BMS-986340, BMS-936558-01, Docetaxel
Pfizer Inc.PFE5PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel /m^2, Relacorilant once daily, Bevacizumab /kg
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib, azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib, KFA115, pembrolizumab, Tulmimetostat
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib, BG-68501, Fulvestrant, BGB-43395
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Exelixis, Inc.EXEL2PHASE2Cabozantinib, cabozantinib, atezolizumab
Xencor, Inc.XNCR3PHASE2vudalimab, XmAb541, XmAb808
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