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Monoclonal Antibodies

Pembrolizumab for Adrenocortical Cancer

Phase 2
Waitlist Available
Led By Diane Reidy-Lagunes, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have histologically- or cytologically- confirmed unresectable or metastatic ACC that is considered incurable by local therapies
Have measurable disease based on RECIST v1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment called pembrolizumab. Researchers want to learn what effects, both good and bad, this immunotherapy has on patients and their cancer.

Who is the study for?
This trial is for adults over 18 with advanced adrenocortical carcinoma (ACC) that can't be removed or cured with surgery. Participants must have measurable disease, provide tissue for testing, and have good organ function. Women of childbearing age must test negative for pregnancy and agree to contraception; men also need to use birth control.Check my eligibility
What is being tested?
The trial is testing the effects of Pembrolizumab, an immunotherapy drug, on patients with ACC. The study aims to understand both the positive outcomes and any potential adverse effects this treatment may have on participants' cancer.See study design
What are the potential side effects?
Pembrolizumab can cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), and it could potentially worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with advanced ACC that cannot be removed with surgery or treated effectively with local therapies.
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You have a disease that can be measured using specific guidelines.
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You have given a sample of tissue for testing the PD-L1 biomarker.
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You should be able to perform daily activities without any major limitations or only have slight limitations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,927 Previous Clinical Trials
591,368 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,860 Previous Clinical Trials
5,047,815 Total Patients Enrolled
Diane Reidy-Lagunes, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
238 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02673333 — Phase 2
Adrenocortical Cancer Research Study Groups: Pembrolizumab
Adrenocortical Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02673333 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02673333 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical conditions is Pembrolizumab most often prescribed?

"Pembrolizumab is an immunotherapy medication used to treat cancer. It can also help patients with conditions like microsatellite instability high and unresectable melanoma who have seen disease progression after chemotherapy."

Answered by AI

Are there any available spots for people in this clinical trial?

"This study has closed recruitment. The clinical trial was first posted on February 1st, 2016 and was last edited on March 3rd, 2022. However, there are presently 2551 trials actively recruiting patients with adrenocortical carcinoma and 1000 studies for Pembrolizumab admitting patients."

Answered by AI

What are the risks associated with Pembrolizumab?

"Pembrolizumab's safety is supported by phase 2 data, but since there is a lack of efficacy data, it received a score of 2."

Answered by AI

What other treatments has Pembrolizumab been tested against in scientific trials?

"Pembrolizumab is being trialed in 1000 active studies, with 122 of those being Phase 3 trials. The majority of these are based in Houston, Texas; however, there are 36053 locations running Pembrolizumab trials globally."

Answered by AI

How many individuals are being given the opportunity to participate in this research project?

"This particular clinical trial is not currently looking for new participants. However, there are 2551 other trials related to adrenocortical carcinoma and 1000 trials related to Pembrolizumab that are actively recruiting patients."

Answered by AI
~4 spots leftby Mar 2025