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UM1 10061 Pembrolizumab + Recombinant Interleukin-12 in Solid Tumors - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test the safety of the study drug called recombinant Interleukin-12 (IL-12) given before and after pembrolizumab.

What is the Condition Being Studied?

Solid tumor that is locally advanced or widespread (metastatic)

Who Can Participate in the Study?

Adult patients with a solid tumor that is locally advanced or widespread (metastatic)

Age Group
Adults

What is Involved?

There are two parts to the study: Group 1 Dosing Finding and Group 2 Dose Continuation.

If you join the study the group you are assigned to depends on when you enter the study. Your doctor will tell you to which group you are assigned.

Group 1- The first several study participants will receive the lowest dose of recombinant Interleukin-12. If the lowest dose does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for the next study participants until side effects occur that require the dose to be lowered. Then the dose finding part of study is closed to enrollment and the dose continuation study group (below) opens for enrollment.

Group 2 - Participants will receive the dose of recombinant Interleukin-12 identified to be safest

Study Details

Full Title
A Phase 1 Study of MK-3475 (Pembrolizumab) in Combination with Recombinant Interleukin-12 in Patients with Solid Tumors
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00087751
NCT:NCT03030378
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698