Pilot Study on the Safety and Effectiveness of Avelumab for Thymoma and Thymic Carcinoma After Platinum-Based Chemotherapy

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03076554

Provider View

This study is testing if the drug Avelumab is safe and effective for treating thymoma and thymic carcinoma that have returned or worsened after standard chemotherapy. Avelumab may help the immune system fight these cancers.

Patient Parameters

Program Overview

Thymoma and thymic carcinoma are cancers that start in the thymus gland. The usual treatment is chemotherapy with platinum-based drugs, but sometimes the cancer comes back or continues to grow. This study is exploring whether Avelumab, a drug that could boost the immune system, is safe and can help treat these cancers when they return or don't respond to initial treatment.

Description

This study is for people with thymoma or thymic carcinoma that has come back or gotten worse after treatment with platinum-based chemotherapy. Avelumab is a drug that may help the immune system fight cancer. The study will test if Avelumab is safe and effective for these patients.

Participants will be screened with tests like blood and urine tests, heart tests, scans, physical exams, and possibly a biopsy to check the cancer. Treatment will be given in 2-week cycles, with Avelumab administered through an IV. Participants will also receive medications like Benadryl and Tylenol to reduce the chance of a reaction to Avelumab. Regular tests and scans will monitor the cancer's response to treatment.

If participants respond well to treatment or their cancer remains stable for at least 12 months, they may continue treatment with a lower dose. The study will also check for any side effects and how well the cancer responds to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed thymoma or thymic carcinoma.
  • Cancer must have returned or worsened after at least one round of platinum-based chemotherapy.
  • Must be 18 years or older.
  • Must have measurable disease according to specific medical criteria.
  • Must have normal organ and blood function.
  • Must agree to use effective contraception if there is a risk of pregnancy.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot be on other cancer treatments or have had major surgery recently.
  • Cannot have had another cancer in the last 2 years, except for certain types like skin cancer.
  • Cannot have active autoimmune diseases that could worsen with treatment.
  • Cannot have untreated brain metastases.
  • Cannot have active infections like hepatitis or HIV.
  • Cannot have had an organ transplant.
  • Cannot have severe allergies to the study drug.
  • Cannot be pregnant or breastfeeding.
  • Cannot have significant heart disease or other serious health conditions.
  • Cannot have a history of drug or alcohol abuse.
  • Cannot have received certain vaccines recently.

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