Phase 3 Trials
Stimuvax® is an innovative cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer, prostate cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1.
Stimuvax is being developed by Merck KGaA of Darmstadt, Germany (Merck) under a license agreement with Oncothyreon. Merck is currently conducting three Phase 3 trials of Stimuvax.
START (Stimulating Targeted Antigenic Responses To NSCLC)
START (Stimulating Targeted Antigenic Responses To NSCLC), is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study is expected to involve more than 1,300 patients in approximately 30 countries.
For more information on the START study, or to find a participating center and eligibility criteria, go to www.nsclcstudy.com or call 1-800-507-5284. The study is also listed on www.clinicaltrials.gov. If you are located outside North America, START / Stimuvax inquiries can be directed to the Merck Communication Center by telephone at +49 6151 72 5200, via the contact form on www.merck.de or via email at service@merck.de.
INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response)
INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response) is a Phase 3 trial of Stimuvax in Asian patients with advanced non-small cell lung cancer (NSCLC).
The trial is anticipated to enroll approximately 420 patients in China, Hong Kong, South Korea, Singapore and Taiwan. INSPIRE is similar in design to START and will evaluate the efficacy, safety and tolerability of Stimuvax in patients with unresectable, stage III NSCLC who have demonstrated either stable disease or an objective response following primary chemo-radiotherapy. The primary endpoint is overall patient survival.
For more information on the INSPIRE trial, please view the listing on www.clinicaltrials.gov.
STRIDE (STimulating immune Response In aDvanced brEast cancer)
STRIDE (STimulating immune Response In aDvanced brEast cancer), is a global Phase 3 trial of Stimuvax in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
The STRIDE trial is anticipated to enroll more than 900 patients at approximately 180 sites in over 30 countries - including North America, Europe, Asia and Australia. Patients with estrogen receptor-positive and/or progesterone receptor-positive, non-resectable locally advanced, recurrent or metastatic breast cancer receiving hormonal therapy will be randomized to receive either Stimuvax or a placebo in a 2:1 ratio. The primary endpoint of STRIDE is progression-free survival. Overall survival, quality of life, tumor response and safety will also be assessed in this study.
The STRIDE trial is listed on www.clinicaltrials.gov. If you are located outside North America, STRIDE / Stimuvax inquiries can be directed to the Merck Communication Center by telephone at +49 6151 72 5200, via the contact form on www.merck.de or via email at service@merck.de.
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