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Checkpoint Inhibitor

Pembrolizumab for Thymic Cancer

Q: What is the aggregate count of participants in this clinical trial?

Affirmative. Clinicaltrials.gov reveals that this research is currently looking for participants, with the initial posting on December 6th 2017 and the most recent edit occurring November 11th 2022. Enrollment requires 37 individuals at two sites.

Q: Are participants still being welcomed into this investigation?

Affirmative, the clinical trial data hosted on clinicaltrials.gov is indicative of this study actively seeking participants. Initial posting was made December 6th 2017 and most recent updates were recorded November 11th 2022. 37 patients are needed from 2 sites for this experiment.

Q: Can you elucidate the most essential aims of this investigation?

The primary objective of this 3 year trial is to measure Dose Limiting Toxicity (DLT) of Pembrolizumab in Unresectable Thymoma and <a href="https://www.withpower.com/clinical-trials/thymic-carcinoma">Thymic carcinoma</a>. Secondary objectives include assessing Progression-free survival with the help of immune related Response Criterion (irRC), iRECIST, Kaplan-Meier estimates, Brookmeyer-Crowley method for median confidence intervals, Greenwood formula for standard errors at landmark time points; response rate assessed by site investigators according to RECIST v1.1.; and overall survival estimated using iRECIST along with Kaplan-Meier estimates

Q: Has the FDA sanctioned pembrolizumab for medicinal use?

As this is only a Phase 1 trial, our team at Power has designated pembrolizumab with a score of 1. This implies that there is limited proof concerning the drug's safety and efficacy.

Q: What clinical indications is treatment with pembrolizumab most often prescribed for?

Pembrolizumab is typically taken to combat malignant neoplasms, yet it can also be utilized therapeutically for advanced cases of <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, microsatellite instability high syndrome, and other conditions that have progressed past chemotherapy.

Q: What precedent has been established regarding pembrolizumab in terms of research and clinical trials?

Currently, there are 963 clinical trials researching the efficacy of pembrolizumab. Of those studies, 122 are in Phase 3 and they're located mainly around Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>. Across <a href="https://www.withpower.com/clinical-trials/all">all</a> 35772 sites that conduct such research, multiple investigations into this medication have been launched.

Phase 1

Recruiting

Led By Anne S. Tsao, 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

No active hepatitis or diagnosis of human immunodeficiency virus (HIV) disease

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases (within 10 days of treatment initiation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This triallooks at the effects of an immunotherapy drug to treat thymoma or thymic cancer. It may help the body's immune system attack the cancer.

Who is the study for?

This trial is for people with thymoma or thymic cancer that can't be surgically removed. Participants must not have significant autoimmune diseases, active hepatitis, HIV, or a history of certain treatments within specific time frames. They should have normal organ function tests and agree to use contraception if applicable.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dosage of pembrolizumab, an immunotherapy drug designed to help the immune system fight cancer by blocking tumor growth. It's given to patients who meet strict health criteria and are willing to provide tissue samples for research.See study design

What are the potential side effects?

Pembrolizumab may cause side effects related to immune response such as inflammation in various organs, potential infusion reactions (like fever or chills), fatigue, skin rashes, hormone gland problems (like thyroid disorders), and could worsen pre-existing autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have active hepatitis or HIV.

Select...

My liver function tests are within the required range.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My thymoma or thymic carcinoma cannot be removed with surgery.

Select...

My hemoglobin level is at least 9 g/dL without needing transfusions or EPO recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Incidence of adverse events

Secondary outcome measures

Overall response rate

Overall survival assessed by iRECIST

Progression-free survival

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention

Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,899 Previous Clinical Trials

5,062,825 Total Patients Enrolled

1 Trials studying Thymic Carcinoma

45 Patients Enrolled for Thymic Carcinoma

National Cancer Institute (NCI)NIH

13,704 Previous Clinical Trials

40,931,411 Total Patients Enrolled

10 Trials studying Thymic Carcinoma

999 Patients Enrolled for Thymic Carcinoma

M.D. Anderson Cancer CenterLead Sponsor

2,985 Previous Clinical Trials

1,789,080 Total Patients Enrolled

1 Trials studying Thymic Carcinoma

18 Patients Enrolled for Thymic Carcinoma

Frequently Asked Questions

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

What is the aggregate count of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this research is currently looking for participants, with the initial posting on December 6th 2017 and the most recent edit occurring November 11th 2022. Enrollment requires 37 individuals at two sites."

Answered by AI

Are participants still being welcomed into this investigation?

"Affirmative, the clinical trial data hosted on clinicaltrials.gov is indicative of this study actively seeking participants. Initial posting was made December 6th 2017 and most recent updates were recorded November 11th 2022. 37 patients are needed from 2 sites for this experiment."

Answered by AI

Can you elucidate the most essential aims of this investigation?

"The primary objective of this 3 year trial is to measure Dose Limiting Toxicity (DLT) of Pembrolizumab in Unresectable Thymoma and Thymic carcinoma. Secondary objectives include assessing Progression-free survival with the help of immune related Response Criterion (irRC), iRECIST, Kaplan-Meier estimates, Brookmeyer-Crowley method for median confidence intervals, Greenwood formula for standard errors at landmark time points; response rate assessed by site investigators according to RECIST v1.1.; and overall survival estimated using iRECIST along with Kaplan-Meier estimates"

Answered by AI

Has the FDA sanctioned pembrolizumab for medicinal use?

"As this is only a Phase 1 trial, our team at Power has designated pembrolizumab with a score of 1. This implies that there is limited proof concerning the drug's safety and efficacy."

Answered by AI

What clinical indications is treatment with pembrolizumab most often prescribed for?

"Pembrolizumab is typically taken to combat malignant neoplasms, yet it can also be utilized therapeutically for advanced cases of melanoma, microsatellite instability high syndrome, and other conditions that have progressed past chemotherapy."

Answered by AI

What precedent has been established regarding pembrolizumab in terms of research and clinical trials?

"Currently, there are 963 clinical trials researching the efficacy of pembrolizumab. Of those studies, 122 are in Phase 3 and they're located mainly around Houston, Texas. Across all 35772 sites that conduct such research, multiple investigations into this medication have been launched."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer

2017. "Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03295227.

All > Thymoma > Thymic Carcinoma