Intratumoral injection of ipilimumab and interleukin-2, patients might as well sleep in the doctor's office for the 26 shots in 8 weeks.
A single lesion (0.5-2.0 cm) in each patient was treated with IL-2 (3 mIU) IT TIW x 2 weeks, then BIW x 6 weeks, with escalating doses of Ipi IT weekly x 8 wks. A minimum of 3 patients were enrolled at each dose level. Endpoints included safety, tumor responses, and changes in systemic T cells. Results: 12 patients were treated at 3 Ipi dose levels (0.5, 1, 2 mg). Treatments were well tolerated. The only grade 3 toxicity observed was injection/tumor site ulceration/necrosis, not a DLT per protocol. Other toxicities were grade 1 in nature. An abscopal effect (response in at least 1 non-injected lesion) was seen in 9/12 patients (75%). 10 patients were evaluable for response by immune-related response criteria: 4 PR (40%) and 6 PD. 1 PD was later found to be a CR by resection. The 2 nonevaluable patients had regression of multiple skin lesions.
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