Contract research organisation (CRO) Pivotal is set to support two Phase II clinical trials of a new immunotherapy drug in metastatic melanoma (MM) and non-small cell lung cancer (NSCLC) patients.
The investigational drug is designed to induce the patient’s own innate and adaptive immune systems to fight cancer.
Pivotal noted that modulation of the patient immune system to stimulate therapeutic anti-tumour immunity is being used as a key mechanism for a variety of solid tumours.
The new immunotherapy will be evaluated as a monotherapy, as well as in combination with an anti-PD1 in two different Phase II studies.
While one trial will assess monotherapy in MM patients, the second one will involve combination therapy for second line MM and NSCLC patients.
Pivotal will provide support for the implementation of this programme across the US and EU.
The company will offer resources and operational services such as start-up, regulatory and clinical operations, medical monitoring, data management, and biostatistics.
Enrolment into the Phase II trials has already been initiated.
Pivotal Regulatory and Clinical Operations vice-president Dr Lourdes Huarte said: “The power of partnerships, such as the one we are embarking on here brings together the best minds and capabilities to accelerate this dynamic area of research and bring therapies to patients with high unmet needs.
“We are delighted to have started enrolment of patients in these two crucial trials and to have been able to deploy our capabilities to accelerate the development of medicines in such a difficult-to-treat area.”
The Phase II trials, which will enrol up to 200 subjects across 25 sites in the US and EU, are intended to measure overall response rate and survival benefit as a primary objective.