A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

Investigating the Effectiveness of Investigational Medication Following Combined Modality Therapy in High Risk Anal Cancer

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer.

Detailed description of study

The purpose of this study is to evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: anal cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have histologically proven stage II (T3N0 only), IIIA, or IIIB invasive anal (anal margin) squamous cell carcinoma; this may include tumors of non-keratinizing histology such as basaloid, transitional cell, or cloacogenic histology
  • Patients will be excluded if they have a T1, T2N0 or M1 cancer

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1807487019 (EA2165)

This study investigates the effectiveness of an investigational medication following combined modality therapy in treating patients with high risk stage II-IIIB anal cancer. Anal cancer is a disease where malignant cells form in the tissues of the anus. The investigational medication is being studied to see if it can improve disease-free survival, which means the length of time after treatment during which no cancer is found, compared to just observing the patient without further treatment.

Participants in this study will receive combined modality therapy, which is a treatment that combines more than one method, such as chemotherapy and radiation. Afterward, they will receive either the investigational medication or be placed under observation to compare outcomes. The investigational medication is not yet approved for this use and is being tested to see how well it works.

  • Who can participate: Adults with stage II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma can participate. Tumors may include non-keratinizing histology such as basaloid, transitional cell, or cloacogenic types. Patients with T1, T2N0, or M1 cancer are not eligible.
  • Study details: Participants will undergo combined modality therapy, which includes treatments like chemotherapy and radiation. After this, they will either receive an investigational medication or be observed to compare the outcomes. The use of a placebo is not mentioned in the study details.

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