RACIN in Patients With Advanced TIL-negative Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 16, 2019

Primary Completion Date

October 27, 2023

Study Completion Date

October 27, 2023

Conditions
Solid Tumor, Adult
Interventions
COMBINATION_PRODUCT

Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib

"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"

Trial Locations (1)

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

All Listed Sponsors
lead

Centre Hospitalier Universitaire Vaudois

OTHER

NCT03728179 - RACIN in Patients With Advanced TIL-negative Solid Tumors | Biotech Hunter | Biotech Hunter