Immunicum ends patient enrolment for Phase II trial of Ilixadencel

9th January 2018 (Last Updated January 9th, 2018 00:00)

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). 

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.

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.

"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."

“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.”

MERECA 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.