This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with with CD20-positive NHL who have progressed on or after rituximab therapy.
Treatment will be administered in 2 phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year or until they experience progressive disease (PD) or experience 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 on 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.
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 AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Phase 1b primary endpoint (safety)
Time frame: 1 year
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Phase 2 primary endpoint (ORR by RECIST)
Time frame: 1 year
ORR by Immune-related response criteria (irRC )
Phase 2 primary endpoint (ORR by irRC)
Time frame: 1 year
ORR by RECIST Version 1.1
Phase 1b secondary endpoint (ORR by RECIST)
Time frame: 1 year
ORR by irRC
Phase 1b secondary endpoint (ORR by irRC)
Time frame: 1 year
Progression-free survival (PFS) by RECIST Version 1.1
Phase 1b and 2 secondary endpoint (PFS by RECIST)
Time frame: 2 years
PFS by irRC
Phase 1b and 2 secondary endpoint (PFS by irRC)
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 (OS)
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
5-fluoro-2,4 (1H,3H)-pyrimidinedione
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
Chimeric murine/human anti-CD20 monoclonal IgG1 kappa antibody
(SBRT)
recombinant human super agonist interleukin-15 (IL-15) complex
Ad5 \[E1-, E2b-\]-mucin 1\[MUC1\]
NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous \[IV\] Infusion
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
Phase 1b and 2 secondary endpoint (DR)
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 (DCR)
Time frame: 2 months
Patient Reported Outcome (PRO) using the FLynnSI-18 questionnaire
Phase 1b and 2 secondary endpoint (PROs)
Time frame: 2 years
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03
Phase 2 secondary endpoint (AEs)
Time frame: 1 year