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Adrenocortical CarcinomaPhase 1NCT04373265

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

A Phase 1 study testing Relacorilant and Pembrolizumab in people with Adrenocortical Carcinoma, run by Corcept Therapeutics at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adrenocortical Carcinoma
What is being tested?
Relacorilant and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesUnited States
Study dates
30 Sep 2020to 12 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed ACC (advanced unresectable and/or metastatic)
  • Measurable disease based upon RECIST v1.1 as determined by the Investigator.
  • Documented GC excess (too much cortisol).
  • For patients who have received mitotane within 3 months prior to screening, mitotane levels must be <4 mg/L at screening.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Adequate organ and bone marrow function (determined through blood and urine tests)
  • Negative pregnancy test for patients of childbearing potential at the Screening and every 6 weeks (+ or - 7 days) in female patients of childbearing potential.

Who cannot join

  • Major surgery within 4 weeks prior to enrollment. If the participant underwent major surgery, they must have recovered adequately prior to starting study treatment.
  • Have received and responded (complete response [CR] or partial response [PR]) to prior treatment with any prior checkpoint inhibitor or any other agents targeting T-cell stimulation pathways
  • Taking a concomitant medication that is a strong Cytochrome P450 3A (CYP3A) inducer, or that is a substrate of CYP3A with a narrow therapeutic index
  • Known untreated parenchymal brain metastasis or have uncontrolled central nervous system (CNS) metastases. Patients must not require steroids and must be neurologically stable without corticosteroids for a minimum of 3 weeks prior to the commencement of the study. Patients with neurologic symptoms must undergo a CT/MRI to rule out occult CNS metastases.
  • Requirement for chronic systemic GC treatment, such as active autoimmune disease requiring systemic treatment (corticosteroids or other immunosuppressive medication)
  • Patients requiring inhaled glucocorticoids but have no other alternative treatment option if their condition deteriorates during the study.
Show all 19Show fewer
  • Clinically relevant toxicity from prior systemic cytotoxic therapies or radiotherapy that in the opinion of the Investigator has not resolved to NCI-CTCAE v5.0 Grade 1 or less prior to the first dose of relacorilant.
  • Treated with the following prior to the first dose of relacorilant:
  • Any investigational product, systemic anticancer therapy, or radiation therapy within 21 days
  • Antibodies or anticancer vaccines within 60 days
  • Mifepristone or other GR antagonists within 5 half-lives of these medications
  • Adrenostatic medications within 5 half-lives of these medications
  • History of severe hypersensitivity to another monoclonal antibody
  • Other concurrent cancer or a history of another invasive malignancy within the last 3 years that has a likelihood of recurrence of >30% within the next 5 years. Adequately treated basal and squamous skin cancers, ductal carcinoma in situ, cervical cancer, prostate cancer, non-muscle invasive urothelial cancer or other tumors curatively treated with no evidence of disease are permissible.
  • Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus including: Chronic or active hepatitis B as diagnosed by serologic tests. In equivocal cases, hepatitis B or C polymerase chain reaction may be performed and must be negative for enrollment.
  • Clinically significant uncontrolled condition(s) or a condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's participation, including but not limited to:
  • Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 3 months before study entry.
  • Active infection that requires parenteral antibiotics.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Site #074, University of Michigan Medical School

    Ann Arbor, Michigan, 48109

  • Site #183, The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Site #051, Memorial Hospital

    New York, New York, 10022

  • Site #030 Mayo Clinic

    Rochester, Minnesota, 55905

  • Site #150, Stanford Cancer Center

    Stanford, California, 94305

  • Site #007, Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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).

Read the detailed description

Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR).

The goal of this study is to assess the safety and efficacy of relacorilant when given in combination with pembrolizumab in patients with advanced adrenocortical carcinoma (ACC) which produces too much stress hormone (cortisol). Too much stress hormone (cortisol) is also called glucocorticoid (GC) excess.

Eligible patients are those with advanced ACC that produces too much cortisol.

Patients will receive treatment until progressive disease (PD) (per RECIST v1.1) is confirmed, experience unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for documentation of disease progression, survival information (i.e., date and cause of death) and subsequent treatment.

Being tested
Relacorilant, Pembrolizumab
Keywords
Adrenocortical Carcinoma, Adrenal Carcinoma, Adrenal Autonomy, Excess Glucocorticoid, Hypertension, Hyperglycemia, Type 2 Diabetes, Impaired Glucose Tolerance, Cortisol, Cushing, Cushing syndrome, Hypercortisolemia, Cushingoid, Moon Face, Dorsocervical Fat Pad, Pembrolizumab, Glucocorticoid Receptor, Relacorilant, GR Antagonist, Adrenal Corticotropic Hormone (ACTH)
Medical subject headings
Adrenocortical Carcinoma, Adrenal Cortex Neoplasms, Hypertension, Hyperglycemia, Diabetes Mellitus, Type 2, Glucose Intolerance, Cushing Syndrome, ACTH Syndrome, Ectopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelacorilantDrug

    Also called CORT125134

    Relacorilant, 100 mg soft gel capsules orally once daily

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab 400 mg infusion every 6 weeks

Study groups in NCT04373265
Study groupRoleWhat they receive
Relacorilant in Combination with PembrolizumabExperimentalParticipants 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.
Receives: Drug: Relacorilant; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting Toxicity (DLT)

    Evaluate the percentage of patients with a dose-limiting toxicity

    Measured: Up to 12 weeks

Secondary outcomes (4)

  1. Non-Progression Rate (NPR)

    Evaluate the non-progression rate (NPR) per RECIST v1.1

    Measured: 24 weeks from enrollment

  2. Progression-Free Survival (PFS)

    Evaluate progression-free survival (PFS) per RECIST v1.1

    Measured: From date of first treatment, until the date of first documented progression or date of death from any cause, whichever came first, up to month 24

  3. Number of Participants with Adverse Events

    Adverse events (AEs) by severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)

    Measured: Up to 37 days post-treatment

  4. Plasma Concentrations of Relacorilant in Combination with Pembrolizumab in Patients with Advanced ACC and Glucocorticoid Excess

    Plasma concentrations of relacorilant in combination with pembrolizumab will be calculated in patients with advanced ACC and glucocorticoid excess

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2020
  2. Study start30 Sep 2020
  3. Primary completion17 Oct 2023
  4. Study completion12 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373265
Sponsor's protocol ID
CORT125134-551
Status last verified
Feb 2024
First submitted
30 Apr 2020
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Relacorilant and Pembrolizumab in people with Adrenocortical Carcinoma, run by Corcept Therapeutics at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting Toxicity (DLT) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04373265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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