9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Ad… (NCT05239182) | Clinical Trial Compass
TerminatedPhase 2
9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma
Stopped: Backbone chemo regimen of gemzar/abraxane no longer most favorable treatment for pancreatic cancer patients.
United States7 participantsStarted 2022-01-26
Plain-language summary
This trial examines how Pancreatic Adenocarcinoma reacts to the addition of 9-ING-41 and retifanlimab to the standard of care chemotherapy treatment, to see if using this combination will help and is able to effect disease progression.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Voluntarily written informed consent and willingness/ability to comply with the protocol requirements
* Has pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer AND is previously untreated with systemic agents in the advanced/metastatic setting.
* Must have at least 1 measurable lesion per RECIST v1.1. Lesions that are radiated should not count as target lesions unless there is evidence of growth post radiation on a subsequent scan prior to trial enrollment.
* Must have available archived tumor tissue at study entry (metastatic tissue preferred to primary tissue)
* Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1000/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 100,000/mL.
* Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 2.5 x ULN (≤ 5 X the upper limit of normal (ULN) in the setting of liver metastasis or infiltration with malignant cells); bilirubin ≤ 1.5 x ULN.
* Adequate renal function: creatinine clearance CrCl \> 60 mL/min measured or calculated by Cockcroft- Gault (C-G) equation (estimated glomerular filtration rate \[eGFR\] can also be used in place of CrCl).
* Serum amylase and lipase ≤ 1.5 x ULN
* Eastern Co-operative Oncology Group (ECOG) performance status (PS) 0 - 1
* Has received the final dose of any of the following treatments/ procedures within the specified minimum intervals before first dose of study drug: Focal radia…
What they're measuring
1
Disease Control Rate (DCR)
Timeframe: Up to approximately 11 months from baseline