A Phase IB Study of Relacorilant and Pembrolizumab Immunotherapy for People with Adrenocortical Carcinoma that Produces Too Much Cortisol

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Full Title

A Phase 1b, Open-Label Study of Relacorilant in Combination with Pembrolizumab for Patients with Adrenocortical Carcinoma with Excess Glucocorticoid Production

Purpose

The purpose of this study is to find the highest dose of the drug relacorilant that works best in combination with pembrolizumab immunotherapy in people with inoperable or metastatic adrenocortical cancer that produces too much of the hormone cortisol (Cushing syndrome). Relacorilant may decrease the negative effects of too much cortisol. Both drugs help boost the immune response against cancer.

Relacorilant is taken orally (by mouth) and pembrolizumab is given intravenously (by vein). Their use in this study is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic adrenocortical cancer that produces too much cortisol.
  • Patients should recover from the serious side effects of prior therapies before entering the study. Previous treatment with immunotherapy is not permitted.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Nitya Raj at 646-888-4849.

Protocol

21-153

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators