Anal cancer recurrent Trials in Disease

Study of Retifanlimab, Carboplatin, and Paclitaxel for Patients with Inoperable or Metastatic Anal Canal Squamous Cell Carcinoma Not Treated with Chemotherapy

This clinical trial is investigating a new treatment approach for patients with squamous cell carcinoma of the anal canal that cannot be removed by surgery or has spread to other parts of the body. The study combines two standard chemotherapy drugs with an investigational immunotherapy medication called Retifanlimab (also known as INCMGA00012).

Main focus: The trial aims to compare the effectiveness of adding Retifanlimab to standard chemotherapy (carboplatin and paclitaxel) versus chemotherapy alone in treating inoperable or metastatic anal canal cancer. This is a double-blind study, meaning neither the participants nor the researchers will know who receives the investigational drug versus a placebo. All medications are given directly into a vein through an intravenous infusion.

Who can participate:

• Adults aged 18 years or older with confirmed inoperable or metastatic squamous cell carcinoma of the anal canal
• Patients who have not received prior systemic chemotherapy for their condition (previous chemotherapy given with radiation therapy is allowed if completed at least 6 months before joining)
• Those with measurable disease that can be tracked through medical imaging
• Patients who are able to carry out light daily activities, assessed through an ECOG performance status score of 0 to 1
• HIV-positive patients may participate if they are stable with controlled viral load and receiving appropriate therapy
• Women and men must agree to use effective contraception during the study and for a period after treatment ends

Who cannot participate:

• Patients who have already received systemic chemotherapy for their anal cancer
• Those with other types of cancer that are not squamous cell carcinoma of the anal canal
• Patients with a history of severe allergic reactions to the study drugs
• Those with serious heart problems, such as recent heart attack or severe heart failure
• Patients with uncontrolled infections or other serious medical conditions
• Pregnant or breastfeeding women
• Those unable to follow study procedures or attend required visits

Investigational drugs:

• Retifanlimab (INCMGA00012): An investigational immunotherapy medication that helps the immune system recognize and attack cancer cells by targeting specific proteins on their surface
• Carboplatin: A well-established chemotherapy drug that works by interfering with cancer cell DNA, preventing them from growing and dividing
• Paclitaxel: Another standard chemotherapy medication that stops cancer cells from dividing by stabilizing their internal structure

Throughout the trial, participants will undergo regular monitoring and assessments including physical examinations, blood tests, and imaging studies to track disease progression and evaluate treatment effectiveness. After completing the treatment phase, follow-up visits will continue to monitor long-term health and any potential side effects.