Nivolumab infusion every 3 weeks prior to lymphodepletion chemotherapy with cyclophosphamide/fludarabine, TIL infusion and interleukin-2. Then nivolumab infusion every 4 weeks up to 12 months.
Tumor harvest for TIL growth in the lab: A sample of the participant’s tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.
Other Name: TIL
Drug: Nivolumab
Nivolumab (Opdivo®), 360 mg, IV infusion every 3 weeks prior to TIL infusion, and then after TIL infusion 480 mg ever 4 weeks for up to 12 months.
Other Name: Opdivo
Drug: Cyclophosphamide
Cyclophosphamide will be administered on days -7 and -6.
Other Name: Cytoxan
Drug: Fludarabine
Fludarabine will then be infused per institutional standard on Days -7 to -3.
Other Name: Fludara
Other: Tumor-infiltrating Lymphocyte Therapy
On day 0, all patients will receive a dose infusion TIL cells.
Other Name: TIL
Drug: Interleukin-2 (IL2)
Participants will receive IL-2 for up to 6 doses, based on participants tolerance and investigator judgement. This will be given after the infusion of the T-cells.
Other Name: IL2
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
