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A Phase Ib Study of MDX-1106 in Patients with Selected Advanced or Recurrent Malignancies
[Protocol 09-012]
- Full Title :
- A PHASE IB, OPEN-LABEL, MULTICENTER, MULTIDOSE, DOSE-ESCALATION STUDY OF MDX-1106 IN SUBJECTS WITH SELECTED ADVANCED OR RECURRENT MALIGNANCIES
- Purpose :
The purpose of this study is to find the highest dose of an investigational drug called MDX-1106 that can be given safely in patients with advanced or recurrent melanoma, kidney, prostate, or lung cancers.
MDX-1106 is an antibody that binds to PD-1, a molecule present on white blood cells called T cells. It is believed that PD-1 controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through using this shut-down method. MDX-1106 may stop PD-1 from turning off the immune system and allow an immune reaction against the cancer to continue.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of advanced or recurrent hormone-refractory prostate cancer, melanoma, renal cell carcinoma, or non-small cell lung cancer that can no longer be treated with standard therapies.
- Patients must have had at least one but no more than five standard therapies for advanced cancer.
- At least 4 weeks must have passed since completion of prior therapies and entry into the study, and patients must have recovered from any side effects.
- Patients may not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Jedd Wolchok at 646-888-2395.
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