UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade
Status:
Active, not recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
This is a phase I/II study that will evaluate the safety and toxicity of this combinatorial
approach. Eligible patients >18 years of age with histologically proven metastatic NSCLC,
melanoma, RCC, or HNSCC who have failed PD-1 / PD-L1 checkpoint blockade therapy will be
enrolled. Patients must have a candidate treatment lesion (subcutaneous, nodal, or visceral)
accessible and safe for radiotherapy and serial intralesional injections as specified by the
protocol. They must also have at least one target lesion (distinct from treatment lesion and
outside of treatment lesion radiation field) evaluable for response by RECIST.
This study will consist of a phase I dose escalation using a standard 3+3 design to determine
safety and MTD of intralesional IL-2 which will be dose escalated in conjunction with
standard fixed doses of RT and Pembrolizumab. At the MTD there will be a phase II dose
expansion which will incorporate a simon-two stage design to assess efficacy and safety.
Patients will receive pembrolizumab and intralesional IL-2 in combination with
hypofractionated radiotherapy.