This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with epithelial ovarian cancer who have progressed on or after SoC therapy.
Treatment will be administered in two phases, an induction and a maintenance phase. Subjects will continue induction treatment for up to 1 year or until they experience progressive disease (PD) or unacceptable toxicity (not correctable with dose reduction), withdraw consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects may remain in the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both the induction and maintenance phases, is 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
Recombinant human anti-VEGF IgG1 monoclonal antibody
5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
Incidence of treatment-emergent adverse events (AEs) and serious AE (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Phase 1b primary endpoint
Time frame: 1 year
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Phase 2 primary endpoint
Time frame: 1 year
ORR by Immune-related response criteria (irRC )
Phase 2 primary endpoint
Time frame: 1 year
ORR by RECIST Version 1.1
Phase 1b secondary endpoint
Time frame: 1 year
ORR by irRC
Phase 1b secondary endpoint
Time frame: 1 year
Progression-free survival (PFS) by RECIST Version 1.1
Phase 1b and 2 secondary endpoint
Time frame: 2 years
PFS by irRC
Phase 1b and 2 secondary endpoint
Time frame: 2 years
Overall survival (OS): time from the date of first treatment to the date of death (any cause)
Phase 1b and 2 secondary endpoint
Time frame: 2 years
Duration of response (DR): time from the date of first response (partial response (PR) or complete response (CR)) to the date of disease progression or death (any cause) whichever occurs first
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2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
5-fluoro-2,4 (1H,3H)-pyrimidinedione
7-alpha-\[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl\]estra-1,3,5-(10)- triene-3,17-beta-diol
Calcium N-\[p-\[\[\[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl\]methyl\]amino\]benzoyl\]-L-glutamate (1:1)
5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
omega-3 acid ethyl esters
cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
Stereotactic Body Radiation Therapy (SBRT)
Recombinant human super agonist IL-15 complex
Ad5 \[E1-, E2b-\]-HER2 vaccine
Ad5 \[E1-, E2b-\]-Brachyury vaccine
Ad5 \[E1-, E2b-\]-MUC1 vaccine
Heat-killed S. cerevisiae yeast expressing the mutated RAS oncoproteins
Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein
NK-92 \[CD16.158V, ER IL-2\]
Phase 1b and 2 secondary endpoint
Time frame: 2 years
Disease control rate (DCR): confirmed complete response, partial response, or stable disease lasting for at least 2 months
Phase 1b and 2 secondary endpoint
Time frame: 2 years
Quality of life (QoL) by patient-reported outcome using the Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) questionnaire
Phase 1b and 2 secondary endpoint
Time frame: 2 years
Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 4.03
Phase 2 secondary endpoint
Time frame: 1 year