#PANCREA TABS PLUS TRIAL#

Received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.

Received radiation therapy encompassing >20% of the bone marrow within 2 weeks or any radiation therapy within 1 week prior to day 1 of protocol therapy.

Major surgery ≤ 3 weeks prior to initiating protocol therapy and/or not recovered from any surgical effects.

Received investigational therapy ≥ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.

If the participant received major surgery, then they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Participants with ≤ grade 2 neuropathy are an exception to these criteria and may qualify for the study.

Systemic anticancer or biological therapy including prior chemotherapy, immunotherapy, targeted small molecule therapy within 14 days prior to investigational agent, or those who have not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier.

Participants who meet any of the following criteria will be excluded: Any prior line of treatment is permitted, including adjuvant. Patients must have had at least one line of prior treatment.One previously unirradiated lesion amenable to radiotherapy at a dose of 8 Gy x 3 and can meet dose constraints, and another unirradiated measurable lesion > 1 cm in size outside the radiation field that can be used as measurable disease.

Patients who have been amenorrhoeic for 14 days prior to treatment start.

total bilirubin ≤ 1.5 x ULN (subjects with Gilbert Syndrome can have a total bilirubin 1 year.

creatinine clearance* ≥ 60 mL/min (if using the Cockcroft-Gault formula).

AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal(subjects with liver metastases can have an AST (SGOT) ≤ 5 x ULN.

Participants must have normal organ and marrow function as defined below:

Life expectancy of greater than 3 months.

Histologically or cytologically confirmed metastatic adenocarcinoma of pancreatic origin.

It is believed that the combination of dostarlimab, niraparib, and radiation therapy may have a greater effect on metastatic pancreatic cancer cells than when these interventions are used alone. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring. Niraparib is a type of drug called a 'PARP inhibitor', which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. The FDA has not approved niraparib for metastatic pancreatic cancer, but it has been approved for other uses. The investigators believe that dostarlimab will inhibit the PD-1 protein, thus allowing the immune cells to recognize and destroy cancer cells. This PD-1 protein controls parts of the immune system (the system in the body that fights off infections and diseases) by shutting down certain immune responses responsible for recognizing and destroying cancer cells. Dostarlimab is a type of antibody (a protein that attaches to other cells to fight off infection) that is believed to work by attaching to a protein called PD-1 on Tcells. Food and Drug Administration (FDA) has not approved dostarlimab as a treatment for any disease. 'Investigational' means that the intervention is being studied. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. This research study is a Phase II clinical trial.

It is expected participants will be on the research study for as long as the experimental interventions are safe, and their metastatic pancreatic cancer does not progress with up to 5 years of follow up after participants stop taking the experimental interventions. An initial 15 participants will be enrolled during the first stage and evaluated for treatment disease control, if none of the initial 15 participants achieve disease control the study will be terminated. It is expected that about 25 people will take part in this research study. The names of the experimental interventions involved in this study are: The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

#PANCREA TABS PLUS TRIAL#

This two-stage single arm phase II trial will evaluate the efficacy of niraparib with dostarlimab and radiation therapy in patients with metastatic pancreatic cancer Why Should I Register and Submit Results?.

Pancrea tabs plus