Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT03295227

Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer

Led by M.D. Anderson Cancer Center · Updated on 2026-01-30

37

Participants Needed

1

Research Sites

525 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase I trial studies the sides effects and best dose of pembrolizumab in treating participants with thymoma or thymic cancer that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

CONDITIONS

Official Title

Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of unresectable thymoma or thymic carcinoma
  • Any prior cancer treatment allowed
  • Willing and able to give written informed consent
  • Measurable disease based on RECIST 1.1 criteria
  • Willing to provide a recent tumor biopsy sample or archived specimen
  • Performance status of 0 or 1 on ECOG scale
  • No history of significant autoimmune diseases such as myasthenia gravis, Lambert-Eaton syndrome, systemic lupus, or rheumatoid arthritis
  • No active hepatitis or HIV infection
  • No prior malignancy within the last 2 years except certain skin cancers or treated cervical cancer
  • Adequate blood counts, kidney, and liver function within specified limits
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 120 days after
  • Male participants of childbearing potential must agree to use contraception during the study and for 120 days after
Not Eligible

You will not qualify if you...

  • Participation in another investigational study or use of investigational therapy within 4 weeks prior to treatment
  • Current use of systemic steroids or immunosuppressive therapy within 7 days before treatment
  • Known active tuberculosis infection
  • Allergy to pembrolizumab or its components
  • Recent use of anti-cancer monoclonal antibodies within 4 weeks or unresolved side effects from prior therapies
  • Recent chemotherapy, targeted therapy, or radiation within 2 weeks or unresolved side effects, except mild neuropathy
  • Known additional active cancer requiring treatment, except certain treated skin or cervical cancers
  • Active brain metastases or carcinomatous meningitis
  • Active autoimmune disease requiring systemic treatment in the past 2 years
  • History or current pneumonitis requiring steroids
  • Active infection needing systemic therapy
  • Conditions or treatments that could interfere with trial participation or safety
  • Psychiatric or substance abuse disorders affecting cooperation
  • Pregnant or breastfeeding women or those planning pregnancy during the study period
  • Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
  • Known HIV infection
  • Active hepatitis B or C infection
  • Receipt of live vaccines within 30 days before starting study treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Anne S. Tsao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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