Nivolumab + Ipilimumab + Radiation in MSS Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This research is being done to study the effects of the combination of ipilimumab, nivolumab, and radiation therapy in people with microsatellite stable pancreatic cancer. The names of the study interventions involved in this study are: * Ipilimumab * Nivolumab * Radiation Therapy

Detailed description public domain (ClinicalTrials.gov)

This research study is a Phase II clinical trial study testing the safety and effectiveness of the combination of ipilimumab, nivolumab, and radiation therapy. The research study procedures include screening for eligibility, and study treatment including evaluations and follow up visits. Participants will be in this research study for as long as the study interventions are safe and beneficial. Participants will then be followed for up to 5 years. The names of the study interventions involved in this study are: * Ipilimumab * Nivolumab * Radiation Therapy It is expected that about 30 people will take part in this research study. Ipilimumab and Nivolumab are both antibodies. An antibody is a protein that attaches to other cells to fight off infection. The antibodies in ipilimumab work by not allowing cancer cell growth. The antibodies in nivolumab work by causing programmed cell death of the cancer cells. Radiation therapy may increase the likelihood of response to interventions like ipilimumab and nivolumab. The U.S. Food and Drug Administration (FDA) has not approved ipilimumab and nivolumab for microsatellite stable pancreatic cancer. but they have been approved for other uses.

Intervention public domain (ClinicalTrials.gov)

Drug: Nivolumab. Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer

Intervention public domain (ClinicalTrials.gov)

Drug: Ipilimumab. Ipilimumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Ipilimumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer

Intervention public domain (ClinicalTrials.gov)

Radiation: Radiation. 3D Conformal Radiotherapy to shrink or kill tumors

Arm public domain (ClinicalTrials.gov)

Nivolumab + Ipilimumab + Radiation (experimental): The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, (Study cycles are 6 weeks.) * Nivolumab via iv, at predetermined dose every 2 weeks for duration of study. * Ipilimumab via iv at a predetermined dose on day 1 of 4 study cycles. * Radiation treatments will be administered every other weekday or 2 days during week 1 of cycle 1.

Primary outcome public domain (ClinicalTrials.gov)

Overall response rate (ORR). Overall response rate (ORR) will be evaluated by RECIST. Nivolumab and ipilimumab combined with radiation will be considered to have promising activity in metastatic MSS pancreatic cancer if at least 3 of 30 patients were to achieve CR or PR. Time frame: 6 weeks.

Secondary outcome public domain (ClinicalTrials.gov)

Disease control rate (DCR). Time frame: Up to 5 yrs.

Secondary outcome public domain (ClinicalTrials.gov)

Number of Participants with Treatment Related Adverse Events as Assessed NCI CTCAE 5.0 guidelines. Time frame: Up to 5 years.

Secondary outcome public domain (ClinicalTrials.gov)

Progression-free survival (PFS). Time frame: Up to 5 years.

Secondary outcome public domain (ClinicalTrials.gov)

Overall survival (OS) in patients. Time frame: Up to 5 years.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * Participants must have histologically or cytologically confirmed metastatic MSS adenocarcinoma of pancreatic origin * Age \>18 years. * ECOG performance status \<2 * Life expectancy of greater than 3 months * Participants must have normal organ and marrow function as defined in Table 1, all screening labs should be performed within 14 days of protocol registration. * Hematological * Absolute neutrophil count(ANC) ≥1000 /mcL * White blood count (WBC) ≥2000 /mcL * Platelets ≥75,000 / mcL * Hemoglobin ≥7.5 g/dL * Renal * Serum creatinine: ≤ Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) OR * Measured or calculated Creatinine clearance should be calculated per institutional standard: ≥ 40 mL/min (if using the Cockcroft-Gault formula below): * (GFR can also be used in place of creatinine or CrCl) * Female CrCl = (140 - age in years) x weight in kg x 0.85/ 72 x serum creatinine in mg/dL * Male CrCl = (140 - age in years) x weight in kg x 1.00/ 72 x serum creatinine in mg/dL * Hepatic * Serum total bilirubin ≤ 1.5 X ULN (subjects with Gilbert Syndrome can have a total bilirubin \<3 mg/dL * AST (SGOT) and ALT (SGPT) ≤ 3 X ULN OR ≤ 5 X ULN for subjects with liver metastases * Coagulation * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants * Activated Partial Thromboplastin Time (aPTT) ≤2.5 X ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants * Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) * Women must not be breastfeeding * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential, ie, who are postmenopausal or surgically sterile as well as azoospermic men do …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 30 participants (estimated).