Immunicum has completed enrolling patients for its ongoing Phase II Metastatic REnal Cell Carcinoma (MERECA) clinical trial of Ilixadencel for the treatment of renal cell cancer (RCC).
A total of 88 patients have been randomised in the trial to meet requirements of the study design and validity of the protocol.
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The international, randomised, controlled and open trial targeted to enrol up to 90 patients.
Immunicum CEO Carlos de Sousa said: “Enrolment completion means we will be able to communicate the key final results in the third quarter of 2019 as planned.
“With the recently secured funding of Skr200m ($24m), we are on track to complete MERECA and reach the first decision point in the multi-indication checkpoint inhibitor combination study.
“As defined by our clinical development plan, these trials will provide further validation of ilixadencel as a safe and unique immune primer with broad potential in combination cancer therapy of solid tumours.”
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By GlobalDataMERECA trial’s primary objective is to provide a proof-of-concept for ilixadencel by achieving multiple endpoints indicative of meaningful clinical impact and safety assessed over an 18-month period.
The trial also intends to examine the safety, tumour-specific immune activation and potential for clinical efficacy of two intratumoral doses of ilixadencel before surgical removal of the tumour-affected kidney and subsequent treatment with the standard of care-drug, sunitinib.
In the control arm of the study, patients are treated with sunitinib only, post-surgical removal of the tumour-affected kidney.
The study also aims to provide data on the median overall survival rate for all patients enrolled.
