Study: NCT03728179

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib
Description: Low Dose Radiation (RT): RT will be administered as single fractions every 2 weeks (Q2W) from cycle C0 to cycle C4. RT will be delivered to a number of metastatic deposits visible by PET/CT, at the PI's discretion.~Cyclophosphamide: 200mg/m2 will be administered as intravenous infusion (IV) Q2W from cycle C0 to C4.~Nivolumab: 240 mg will be administered as IV Q2W from cycle C1 to C4.~Ipilimumab: 1mg/kg will be administered as IV every 6 weeks (Q6W) from cycle C1 to C4~Aspirin: 300mg will be administered orally daily from cycle C1 to C4. All subjects will receive mandatory gastric prophylaxis with an oral H2 antagonist.~Celecoxib: 200mg will be administered orally twice a day from cycle C1 to C4.~At the end of cycle C4, patients eligible for maintenance will be treated with nivolumab at 240mg Q2W until progression or excessive toxicity; celecoxib will be maintained if the drug is well tolerated

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib
Description: Low Dose Radiation (RT): RT will be administered as single fractions every 2 weeks (Q2W) from cycle C0 to cycle C4. RT will be delivered to a number of metastatic deposits visible by PET/CT, at the PI's discretion.~Cyclophosphamide: 200mg/m2 will be administered as intravenous infusion (IV) Q2W from cycle C0 to C4.~Nivolumab: 240 mg will be administered as IV Q2W from cycle C1 to C4.~Ipilimumab: 1mg/kg will be administered as IV every 6 weeks (Q6W) from cycle C1 to C4~Aspirin: 300mg will be administered orally daily from cycle C1 to C4. All subjects will receive mandatory gastric prophylaxis with an oral H2 antagonist.~Celecoxib: 200mg will be administered orally twice a day from cycle C1 to C4.~At the end of cycle C4, patients eligible for maintenance will be treated with nivolumab at 240mg Q2W until progression or excessive toxicity; celecoxib will be maintained if the drug is well tolerated

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib
Description: Low Dose Radiation (RT): RT will be administered as single fractions every 2 weeks (Q2W) from cycle C0 to cycle C4. RT will be delivered to a number of metastatic deposits visible by PET/CT, at the PI's discretion.~Cyclophosphamide: 200mg/m2 will be administered as intravenous infusion (IV) Q2W from cycle C0 to C4.~Nivolumab: 240 mg will be administered as IV Q2W from cycle C1 to C4.~Ipilimumab: 1mg/kg will be administered as IV every 6 weeks (Q6W) from cycle C1 to C4~Aspirin: 300mg will be administered orally daily from cycle C1 to C4. All subjects will receive mandatory gastric prophylaxis with an oral H2 antagonist.~Celecoxib: 200mg will be administered orally twice a day from cycle C1 to C4.~At the end of cycle C4, patients eligible for maintenance will be treated with nivolumab at 240mg Q2W until progression or excessive toxicity; celecoxib will be maintained if the drug is well tolerated

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib
Description: Low Dose Radiation (RT): RT will be administered as single fractions every 2 weeks (Q2W) from cycle C0 to cycle C4. RT will be delivered to a number of metastatic deposits visible by PET/CT, at the PI's discretion.~Cyclophosphamide: 200mg/m2 will be administered as intravenous infusion (IV) Q2W from cycle C0 to C4.~Nivolumab: 240 mg will be administered as IV Q2W from cycle C1 to C4.~Ipilimumab: 1mg/kg will be administered as IV every 6 weeks (Q6W) from cycle C1 to C4~Aspirin: 300mg will be administered orally daily from cycle C1 to C4. All subjects will receive mandatory gastric prophylaxis with an oral H2 antagonist.~Celecoxib: 200mg will be administered orally twice a day from cycle C1 to C4.~At the end of cycle C4, patients eligible for maintenance will be treated with nivolumab at 240mg Q2W until progression or excessive toxicity; celecoxib will be maintained if the drug is well tolerated

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib
Description: Low Dose Radiation (RT): RT will be administered as single fractions every 2 weeks (Q2W) from cycle C0 to cycle C4. RT will be delivered to a number of metastatic deposits visible by PET/CT, at the PI's discretion.~Cyclophosphamide: 200mg/m2 will be administered as intravenous infusion (IV) Q2W from cycle C0 to C4.~Nivolumab: 240 mg will be administered as IV Q2W from cycle C1 to C4.~Ipilimumab: 1mg/kg will be administered as IV every 6 weeks (Q6W) from cycle C1 to C4~Aspirin: 300mg will be administered orally daily from cycle C1 to C4. All subjects will receive mandatory gastric prophylaxis with an oral H2 antagonist.~Celecoxib: 200mg will be administered orally twice a day from cycle C1 to C4.~At the end of cycle C4, patients eligible for maintenance will be treated with nivolumab at 240mg Q2W until progression or excessive toxicity; celecoxib will be maintained if the drug is well tolerated

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib
Description: Low Dose Radiation (RT): RT will be administered as single fractions every 2 weeks (Q2W) from cycle C0 to cycle C4. RT will be delivered to a number of metastatic deposits visible by PET/CT, at the PI's discretion.~Cyclophosphamide: 200mg/m2 will be administered as intravenous infusion (IV) Q2W from cycle C0 to C4.~Nivolumab: 240 mg will be administered as IV Q2W from cycle C1 to C4.~Ipilimumab: 1mg/kg will be administered as IV every 6 weeks (Q6W) from cycle C1 to C4~Aspirin: 300mg will be administered orally daily from cycle C1 to C4. All subjects will receive mandatory gastric prophylaxis with an oral H2 antagonist.~Celecoxib: 200mg will be administered orally twice a day from cycle C1 to C4.~At the end of cycle C4, patients eligible for maintenance will be treated with nivolumab at 240mg Q2W until progression or excessive toxicity; celecoxib will be maintained if the drug is well tolerated

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib
Description: Low Dose Radiation (RT): RT will be administered as single fractions every 2 weeks (Q2W) from cycle C0 to cycle C4. RT will be delivered to a number of metastatic deposits visible by PET/CT, at the PI's discretion.~Cyclophosphamide: 200mg/m2 will be administered as intravenous infusion (IV) Q2W from cycle C0 to C4.~Nivolumab: 240 mg will be administered as IV Q2W from cycle C1 to C4.~Ipilimumab: 1mg/kg will be administered as IV every 6 weeks (Q6W) from cycle C1 to C4~Aspirin: 300mg will be administered orally daily from cycle C1 to C4. All subjects will receive mandatory gastric prophylaxis with an oral H2 antagonist.~Celecoxib: 200mg will be administered orally twice a day from cycle C1 to C4.~At the end of cycle C4, patients eligible for maintenance will be treated with nivolumab at 240mg Q2W until progression or excessive toxicity; celecoxib will be maintained if the drug is well tolerated