IRB #

IRB00012008

Title

CPDR001X2101: Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients with Advanced Malignancies

Principal Investigator

Matthew Taylor

Study Purpose

To determine the safety and efficacy of PDR001 (the study drug) in adult patients with solid tumors.

Medical Condition(s)

Phase 1: Advanced solid tumors
Phase 2: Patients with advanced melanoma, non-small cell lung cancer (NSCLC), or triple negative breast cancer (TNBC)

Eligibility Criteria

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.

Age Range

18 - 100

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Novartis

Recruitment End

12/31/2030

Compensation Provided

No


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