Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
Active Comparator: Cohort A Control Treatment Arm

SBRT + gemcitabine + nab-paclitaxel

Drug: Nab-paclitaxel

Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

Drug: Gemcitabine

2′, 2′-difluoro 2’deoxycytidine, dFdC

Procedure: SBRT

Stereotactic Body Radiation Therapy

Experimental: Cohort A Experimental Treatment Arm 1

SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin HCl + N-803

Biological: N-803

Recombinant human super agonist interleukin-15 (IL-15) complex

Drug: Aldoxorubicin HCl

Aldoxorubicin hydrochloride

Drug: Nab-paclitaxel

Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

Drug: Gemcitabine

2′, 2′-difluoro 2’deoxycytidine, dFdC

Drug: Cyclophosphamide

2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

Procedure: SBRT

Stereotactic Body Radiation Therapy

Experimental: Cohort A Experimental Treatment Arm 2

SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK

Biological: N-803

Recombinant human super agonist interleukin-15 (IL-15) complex

Drug: Aldoxorubicin HCl

Aldoxorubicin hydrochloride

Biological: PD-L1 t-haNK

PD-L1 t-haNK suspension for infusion

Drug: Nab-paclitaxel

Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

Drug: Gemcitabine

2′, 2′-difluoro 2’deoxycytidine, dFdC

Drug: Cyclophosphamide

2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

Procedure: SBRT

Stereotactic Body Radiation Therapy

Active Comparator: Cohort B Control Treatment Arm

Irinotecan liposome + 5-FU/leucovorin

Drug: 5-Fluorouracil

5-fluoro-2,4 (1H,3H)-pyrimidinedione

Drug: Leucovorin

L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt

Drug: Irinotecan liposome

Irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3′,4′:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1′-carboxylate, monohydrochloride, trihydrate

Experimental: Cohort B Experimental Treatment Arm

SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK

Biological: N-803

Recombinant human super agonist interleukin-15 (IL-15) complex

Drug: Aldoxorubicin HCl

Aldoxorubicin hydrochloride

Biological: PD-L1 t-haNK

PD-L1 t-haNK suspension for infusion

Drug: Nab-paclitaxel

Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

Drug: Gemcitabine

2′, 2′-difluoro 2’deoxycytidine, dFdC

Drug: Cyclophosphamide

2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

Procedure: SBRT

Stereotactic Body Radiation Therapy

Experimental: Cohort C Experimental Treatment Arm

SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin + N-803 + PD-L1 t-haNK

Biological: N-803

Recombinant human super agonist interleukin-15 (IL-15) complex

Drug: Aldoxorubicin HCl

Aldoxorubicin hydrochloride

Biological: PD-L1 t-haNK

PD-L1 t-haNK suspension for infusion

Drug: Nab-paclitaxel

Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

Drug: Gemcitabine

2′, 2′-difluoro 2’deoxycytidine, dFdC

Drug: Cyclophosphamide

2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

Procedure: SBRT

Stereotactic Body Radiation Therapy

Source: View full study details on ClinicalTrials.gov

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October 29, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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