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Pembrolizumab + Mitotane for Adrenocortical Cancer
Phase 2
Recruiting
Led By Mouhammed Habra, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male/female participants who are at least 18 years of age with histologically confirmed diagnosis of ACC
Female participants must not be pregnant or breastfeeding and must meet contraceptive requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial will study if adding a drug called pembrolizumab to a drug called mitotane can help control ACC, and safety.
Who is the study for?
Adults with confirmed adrenocortical carcinoma (ACC) can join this trial. They must have measurable disease, be in good physical condition, and not pregnant or breastfeeding. Contraception is required for men and women. Participants should not have had certain recent treatments or vaccinations, active infections like HIV/Hepatitis B/C, severe allergies to the drugs being tested, other cancers within 2 years, or conditions that could affect study participation.Check my eligibility
What is being tested?
The trial tests if pembrolizumab combined with mitotane improves treatment for advanced ACC compared to standard care. It's a phase II study focusing on how well patients respond to the combination and its safety profile.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, allergic responses to drug components, potential lung issues like pneumonitis, fatigue from immune activation and hormone imbalances due to mitotane.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with a confirmed diagnosis of ACC.
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I am not pregnant or breastfeeding and follow the required contraceptive guidelines.
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I agree to use birth control and not donate sperm during the study.
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I can carry out all my usual activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lead-in PhaseExperimental Treatment2 Interventions
Participants will first have a Lead-in Phase in which participants receive only mitotane. This will be 4 weeks long in most participants. Participants will then begin receiving pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitotane
2022
Completed Phase 3
~420
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,311 Total Patients Enrolled
Mouhammed Habra, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable blood thinner regimen for the last 28 days.Your disease must be able to be measured using a specific set of guidelines called RECIST 1.1.I have an immune system disorder or I'm on long-term steroids.My organs are functioning well according to the test results.I have HIV and active Hepatitis B and C.I am currently on medication for an infection.I have metastatic ACC and may have tried one treatment (not immunotherapy), or started MT recently, or had metastases develop while on mitotane.I have received a transplant from another person.I am 18 or older with a confirmed diagnosis of ACC.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I agree to use birth control and not donate sperm during the study.My cancer has spread to my brain or its coverings.I have been treated for an autoimmune disease in the last 2 years.I have had cancer treatment or radiation within the set time limits.You have been diagnosed with Hepatitis B or C.I am a woman of childbearing potential and not pregnant.I have another cancer that is getting worse or was treated in the last 2 years.I have or had lung inflammation that needed steroids.I don't have any health issues that would stop me from completing the study.You have a severe allergic reaction to pembrolizumab or any of its ingredients.I have not received a live vaccine in the last 30 days.I can carry out all my usual activities without help.I have previously received treatments targeting my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Lead-in Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still taking place for this clinical trial?
"Evidently, this clinical trial is not actively recruiting patients as per the information on clinicaltrials.gov; initially posted in January of 2023 and recently updated in November 2022. Despite its lack of participation opportunity, there are still 2474 other trials that require enrolment at present."
Answered by AI
Has the Lead-in Phase received ratification from the FDA?
"Lead-in Phase has been assessed with a score of 2 on the safety scale since clinical data exists to back its relative security, yet there is no evidence for efficacy."
Answered by AI
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