CPDR001X2101: Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients with Advanced Malignancies
To determine the safety and efficacy of PDR001 (the study drug) in adult patients with solid tumors.
Phase 1: Advanced solid tumors
Phase 2: Patients with advanced melanoma, non-small cell lung cancer (NSCLC), or triple negative breast cancer (TNBC)
1. Male or female aged 18 or older
2a. Phase 1: Advanced solid tumor who has progressed despite standard therapy and have no other standard therapy options.
2b. Phase 2: Advanced melanoma, NSCLC, or TNBC that has progressed despite standard therapy
3. Cannot have received prior PD-1 or PD-L1 directed therapy.
4. Cannot require chronic treatment with systemic steroid therapy or any immunosuppressive medication.
Other eligibility criteria apply.
18 - 100
Healthy Volunteers Needed
Duration of Participation
Patients will receive the study drug until their disease gets worse or they develop intolerable side effects. After that subjects will be contacted by phone every 3 months.
Knight Clinical Trials Information Line