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Clinical Trials

Date: 2016-07-06

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Pfizer (USA - NY) Merck KGaA (Germany)

Product: avelumab (MSB0010718C)

Action mechanism:

monoclonal antibody/immune checkpoint inhibitor. MSB0010718C (avelumab) is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses and inhibits tumor growth.

Pfizer and Merck KGaA are jointly developing avelumab (MSB0010718C), an investigational anti-PD-L1 antibody currently in development by Merck KGaA as a potential treatment for multiple types of cancer.

Disease: ovarian cancer

Therapeutic area: Cancer - Oncology

Country: Canada, Japan, USA

Trial details:

JAVELIN Ovarian 100 is an open-label, international, multi-center, randomized (1:1:1) Phase III trial in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). This study is designed to evaluate
the potential superiority of two first-line therapies with avelumab and platinum based chemotherapy versus platinum-based chemotherapy alone, as assessed by progression-free survival.  The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients. (NCT02718417)

Latest news:

* On July 6, 2016, Merck KGaA and Pfizer announced the initiation of a Phase III study, JAVELIN Ovarian 100, to
evaluate the efficacy and safety of avelumab* in combination with, and/or as maintenance treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage III or Stage IV) with previously untreated epithelial ovarian cancer. JAVELIN Ovarian 100 is the first Phase III study evaluating the addition of an immune checkpoint inhibitor to standard-of-care in first-line treatment for this disease. The study will enroll approximately 950 patients, who will receive concurrent avelumab and chemotherapy, avelumab following chemotherapy, or chemotherapy alone.
In December 2015, Merck KGaA and Pfizer announced the initiation of an international Phase III study of avelumab as a treatment for platinum-resistant/refractory ovarian cancer. As of May 2016, the complete JAVELIN clinical development program for avelumab includes approximately 2,200 patients enrolled, being treated across more than 15 tumor types.

Is general: Yes