Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Meta… (NCT04493060) | Clinical Trial Compass
CompletedPhase 2
Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer
United States22 participantsStarted 2020-12-28
Plain-language summary
This phase II trial studies how well niraparib and dostarlimab work in treating patients with germline or somatic BRCA1/2 and PALB2 mutated pancreatic cancer that has spread to other places in the body (metastatic). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as dostarlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and dostarlimab may kill more tumor cells.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Presence of either a germline deleterious mutation or somatic deleterious mutation in any one of the genes in our proposed gene-panel as determined by any of the commercially available or institutional testing platforms. Note: The somatic mutation could be either on a tissue-based test or the circulating tumor DNA (ctDNA)-based assay. The 6 genes that would determine eligibility would be: BRCA1/2, PALB2, BARD1, RAD51c, RAD51d
* Provide written informed consent
* Histological/cytological confirmation of diagnosis of metastatic pancreatic ductal adenocarcinoma
* At least one but no more than two prior lines of systemic therapy for metastatic disease (maintenance therapy is not considered a line of treatment)
* Note: Patients who have not had any prior chemotherapy can refuse chemotherapy and be considered eligible. This refusal and their reason for refusal would have to be documented
* Received a platinum agent as part of first or second line treatment (unless contraindicated)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Serum creatinine =\< 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) \>= 60 mL/min using the Cockcroft-Gault Equation (=\< 14 days prior to registration)
* Hemoglobin \>= 9.0 g/dL (=\< 14 days prior to registration)
* Absolute neutrophil count \>= 1500/uL (=\< 14 days prior to registration:)
* Platelets \>= 100 x 10\^9/L (=\< 14 days prior to registration)
* Total bilirubin…