Publication date: Jun 03, 2019
The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy. Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an injection of IP-001. IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to thermally liberated tumor antigens. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn ‘cold’ tumors into ‘hot’ tumors, inducing a systemic immune response and resulting in shrinkage of the treated tumor including long-term response mediated by the patient’s immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) even those that are outside or distant from the treated area. This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors (‘all comers’, Part 1 – safety run in). Further information on safety and tolerability and as well preliminary antitumor activity will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1) and addition, in melanoma patients the anti-tumor activity will be defined as a primary objective (Part 2, Cohort 2). The trial treatment consists of an Ablation + IP-001 in 4-week intervals for up to six scheduled treatments. Thermal ablation will be performed according to the instruction of the medical device and IMP IP-001 will be administered in different dose levels according to the trial design. A follow up of all patients until progression of disease or until start of a subsequent treatment is part of the trial.
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