Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)

Part of paid clinical trials in Stanford, California.

Sponsor
Corcept Therapeutics
Study ID
NCT04373265
Phase
PHASE1
Status
Completed

Conditions

  • Adrenocortical Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relacorilant — DRUG
    Relacorilant, 100 mg soft gel capsules orally once daily
  • Pembrolizumab — DRUG
    Pembrolizumab 400 mg infusion every 6 weeks

Study Details

This study will investigate the safety and efficacy of Relacorilant in combination with Pembrolizumab for Patients with Adrenocortical Carcinoma which Produces Too Much Stress Hormone (Cortisol).

Key Dates

First listed
May 4, 2020
Start date
Sep 30, 2020
Status verified
Feb 2024
Primary completion
Oct 17, 2023
Completion
Jan 12, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Relacorilant in Combination with Pembrolizumab
    Participants will be treated on Day -3 to Day 1 (Cohort 1 under fasting conditions) or Day -6 to Day 1 (Cohort 2 under fed conditions) for Cycle 1 only. During the lead-in period, 300 mg relacorilant will be administered daily for 4 -7 days. Patients will receive their first pembrolizumab infusion on Cycle 1 Day 1. The participants will then receive combined treatment from Cycle 1 Day 1 until confirmed PD or unacceptable toxicity. Pembrolizumab will be administered every 6 weeks (on Day 1 of each 42-day cycle) and relacorilant will be administered daily. Optional Cohort 3 will lead-in with 400 mg relacorilant once daily for 7 days and combined treatment of relacorilant and pembrolizumab, depending on PD and toxicity.

Primary Outcome Measure

Dose-limiting Toxicity (DLT) [ Time Frame: Up to 12 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Site #150, Stanford Cancer CenterStanfordCalifornia94305-
Site #007, Moffitt Cancer CenterTampaFlorida33612-
Site #074, University of Michigan Medical SchoolAnn ArborMichigan48109-
Site #030 Mayo ClinicRochesterMinnesota55905-
Site #051, Memorial HospitalNew YorkNew York10022-
Site #183, The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Stanford, CA

By research site
Site #150, Stanford Cancer Center· Stanford, CASite #007, Moffitt Cancer Center· Tampa, FLSite #074, University of Michigan Medical School· Ann Arbor, MISite #030 Mayo Clinic· Rochester, MNSite #051, Memorial Hospital· New York, NYSite #183, The University of Texas M.D. Anderson Cancer Center· Houston, TX

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