Switch Maintenance in Pancreatic (NCT05419479) | Clinical Trial Compass
SuspendedPhase 1/2
Switch Maintenance in Pancreatic
Stopped: Efficacy concerns.
United States46 participantsStarted 2022-11-30
Plain-language summary
This study is being done to test the safety and effectiveness of combining domvanalimab (AB154), zimberelimab (AB122), and APX005M with pancreatic cancer that has spread to other parts of body.
This research study involves immunotherapy. Immunotherapy triggers the body's immune system to fight cancer cells.
The names of the study drugs involved in this study are:
* Domvanalimab (also known as AB154)
* Zimberelimab (also known as AB122)
* APX005M
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically confirmed pancreatic cancer (adenocarcinoma, squamous, or adenosquamous histologies) that is metastatic and for which standard curative or palliative measures do not exist or are no longer effective. Locally advanced patients are not eligible.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
* Participants must have received 8-12 cycles (4-6 months) of first-line FOLFIRINOX or modified FOLFIRINOX with stable disease or better.
* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of domvanalimab + zimberelimab + APX005M in participants \<18 years of age, children are excluded from this study.
* ECOG performance status ≤1
* Participants must have adequate organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,500/mcL
* platelets ≥100,000/mcL
* total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except in patients with documented Gilbert's syndrome, who must have a total bilirubin ≤ 3 x ULN
* AST(SGOT)/ALT(SGPT) ≤ 2.5 x institution's upper limit of normal (ULN) for patients with no concurrent liver metastases, OR ≤ 5.0 x institution's ULN f…