Study of Spartalizumab and Drug Combination for Patients with Metastatic Anal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called metastatic squamous cell anal carcinoma. This is a cancer that starts in the cells lining the anus and has spread to other parts of the body. The study is testing a combination of treatments to see how well they work together. The treatments being studied include a medication called Spartalizumab (also known by its code name PDR001), and a combination of chemotherapy drugs known as mDCF, which includes Docetaxel, Cisplatin, and Fluorouracil. Additionally, the study involves the use of radiotherapy, which is a treatment that uses high doses of radiation to kill cancer cells.

The purpose of this study is to evaluate how effective these treatments are in preventing the cancer from getting worse over a period of one year. Participants in the study will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several months, and participants will be monitored regularly to assess their response to the treatment and to check for any side effects.

Throughout the study, participants will undergo various tests and scans, such as a CT scan or MRI, to help doctors see how the cancer is responding to the treatment. The goal is to find out if this combination of treatments can help control the cancer and improve the quality of life for patients with this type of cancer. The study will also help researchers understand more about the safety and effectiveness of these treatments when used together.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A CT scan and PET scan are performed within 30 days prior to inclusion to evaluate the presence of lesions.

2 treatment initiation

The treatment phase begins with the administration of medications. The regimen includes docetaxel, cisplatin, and fluorouracil, which are given as a solution for infusion.

Docetaxel is administered intravenously. Cisplatin and fluorouracil are also given as solutions for infusion. The specific dosages and frequency are determined by the study protocol.

3 spartalizumab administration

Spartalizumab is administered intravenously. This medication is part of the treatment regimen and is given according to the study schedule.

4 radiotherapy

Radiotherapy is included in the treatment plan. The schedule and dosage are determined by the study protocol and are designed to work in conjunction with the medication regimen.

5 monitoring and follow-up

Throughout the study, regular monitoring is conducted to assess the response to treatment and to check for any side effects. This includes physical examinations and imaging tests.

The primary goal is to evaluate the Progression-Free Survival rate at 1 year, which means assessing how long patients live without the disease getting worse.

6 completion of study

The study is estimated to conclude by June 2026. At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Must be a male or female who is at least 18 years old.
Must have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale, which is a way to measure how well a person can perform daily activities.
Must have a confirmed diagnosis of metastatic or locally advanced recurrent squamous cell carcinoma of the anus, which means the cancer has spread or come back in the anus area.
Must have a lesion that can be evaluated using a CT scan or MRI, assessed by specific criteria called RECIST v1.1.
Must be eligible for a specific treatment regimen called mDCF.
Must not have had any previous systemic treatments like immunotherapy or chemotherapy.
Must have had a CT scan within 30 days before joining the study.
Must have had a PET scan within 30 days before joining the study.
Must have a life expectancy of at least 12 months.
Must have adequate organ and bone marrow function, which means the body is working well enough to handle the study treatment. This is checked by specific blood tests and other criteria.
Must have signed and dated an informed consent form, showing they understand the study and agree to participate.
Must be affiliated with or a beneficiary of the French social security system.
Must be able to follow the study protocol, as judged by the study doctor.

Who Cannot Join the Study?

Patients who have a different type of cancer than metastatic squamous cell anal carcinoma cannot participate. This type of cancer has spread from the anal area to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who belong to a specific clinical trial group that is not included in this study cannot participate.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population, such as those who may not be able to give informed consent, are not excluded from this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
IHFB Cognacq Jay	Levallois-Perret	France
Centre Hospitalier Regional Universitaire	Besançon	France
Hopital Nord Franche-Comte	Belfort	France
Cekflm Lktw Btsaml	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	09.06.2022

Trial locations

Investigated drugs:

Spartalizumab is an investigational medication being studied for its potential to help the immune system fight cancer. It is a type of therapy known as an immune checkpoint inhibitor, which may help the body recognize and attack cancer cells more effectively.

Docetaxel is a chemotherapy drug used to treat various types of cancer. It works by interfering with the growth and spread of cancer cells in the body.

Cisplatin is another chemotherapy medication that helps to kill cancer cells by damaging their DNA, which prevents them from dividing and growing.

5-Fluorouracil is a chemotherapy drug that targets cancer cells by inhibiting their ability to synthesize DNA, thereby slowing or stopping their growth.

Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. It works by damaging the DNA inside the cancer cells, which prevents them from growing and dividing.

Investigated diseases:

Anal squamous cell carcinoma

Metastatic Squamous Cell Anal Carcinoma – This is a type of cancer that begins in the squamous cells lining the anal canal and has spread to other parts of the body. It typically starts as a small growth or lesion in the anal area and can progress to involve nearby tissues and lymph nodes. As the disease advances, cancer cells can travel through the bloodstream or lymphatic system to distant organs, forming new tumors. Symptoms may include changes in bowel habits, bleeding, or discomfort in the anal region. The progression of the disease can vary, with some individuals experiencing rapid spread while others may have a slower course. The focus of studies often includes understanding how the disease spreads and identifying factors that influence its progression.

Trial ID:

2024-516005-23-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Spartalizumab and Drug Combination for Patients with Metastatic Anal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?