Study of Atezolizumab and Tiragolumab with Chemoradiotherapy for Patients with Localized Anal Canal Squamous Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called squamous cell carcinoma of the anal canal. The study is testing a combination of treatments to see if they can help patients achieve complete remission, which means the cancer is no longer detectable. The treatments being tested include two medications, Atezolizumab and Tiragolumab, which are given alongside standard treatments like chemotherapy and radiation therapy. Atezolizumab and Tiragolumab are both types of immunotherapy, which means they help the body’s immune system fight cancer.

The purpose of the study is to determine if this combination of treatments is effective in treating patients with localized squamous cell carcinoma of the anal canal. The study will involve patients receiving these treatments over a period of time, and their progress will be monitored to see if the cancer goes into remission. The study will also look at other outcomes, such as how long patients remain free of cancer, their overall survival, and any side effects they may experience.

Participants in the study will receive the treatments as a solution for infusion, which means the medication is given directly into the bloodstream through a vein. The study will last for several months, and patients will have regular check-ups to monitor their health and the effectiveness of the treatment. The goal is to see if this new combination of treatments can improve outcomes for patients with this type of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and cancer diagnosis.

A written informed consent is required before any trial activities begin.

2 initial assessment

An initial assessment is conducted to evaluate health status and confirm the presence of squamous cell carcinoma of the anal canal.

A tumor biopsy is required for further analysis.

3 treatment phase

The treatment involves a combination of atezolizumab and tiragolumab, administered as a concentrate for solution for infusion.

Chemoradiotherapy is also part of the treatment plan, targeting the cancer cells in the anal canal.

4 treatment schedule

The medications are administered according to a specific schedule, which is determined by the healthcare team.

The duration of the treatment phase is planned to ensure the best possible outcome.

5 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and manage any side effects.

Follow-up visits are scheduled to evaluate the effectiveness of the treatment and ensure the absence of residual disease.

6 end of treatment evaluation

At the end of the treatment phase, a comprehensive evaluation is performed to determine if complete remission has been achieved.

This includes clinical assessments and possibly additional biopsies to confirm the absence of cancer.

Who Can Join the Study?

Must be a male or female who is 18 years old or older.
Must have normal organ and bone marrow function, which will be checked before starting the study. This includes:
- Hemoglobin (a protein in red blood cells) level of at least 9.0 g/dL. Blood transfusions can be used to meet this requirement.
- Absolute neutrophil count (a type of white blood cell) of at least 1500 per mm³.
- Platelet count (cells that help with blood clotting) of at least 100,000 per mm³.
- Serum total bilirubin (a substance made by the liver) level of 1.5 times the normal limit or less. Exceptions apply for certain conditions like Gilbert’s syndrome.
- Serum transaminases (liver enzymes) levels of 2.5 times the normal limit or less.
- Serum albumin (a protein in the blood) level of at least 25 g/L.
- Creatinine (a waste product in the blood) level of 1.5 mg/dL or less, or a creatinine clearance rate of more than 60 mL/min.
No active infection that requires antibiotics.
Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for a certain period after the study ends.
Both male and female participants must agree to use effective birth control methods during the study and for a certain period after the study ends.
Must be willing and able to follow the study rules, including attending scheduled visits and treatments.
Must provide written consent to participate in the study.
Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
Must have a confirmed diagnosis of squamous cell carcinoma of the anal canal, including certain subtypes.
Must have cancer that is located in the anal canal and has not spread to distant parts of the body, specifically stages II, IIIA, and IIIB.
Must provide a tumor biopsy sample for research purposes. If not available, a new biopsy may be needed.
Must have at least one lesion that can be evaluated.
Must be eligible for radical chemoradiotherapy according to international guidelines.
Must have a normal life expectancy, not considering the cancer risk.

Who Cannot Join the Study?

Patients who have a different type of cancer than squamous cell carcinoma of the anal canal cannot participate. This is a specific type of cancer that affects the anal canal.
Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, are not eligible to participate.
Patients who do not meet the specific health criteria required for the study cannot participate. This includes having other health conditions that might interfere with the study.
Patients who are not able to follow the study procedures or attend all required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario De Leon	Leon	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital General Universitario De Ciudad Real	Ciudad Real	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Ibdyepfh Cqpbja Djygsqvkfhoexrmwy	L'hospitalet De Llobregat	Spain
Cfftbrvn Sksgkujy Ipoleesn	L'hospitalet De Llobregat	Spain
Pwxn Tcnii Hwnkrjcd Uavjfgtchatp	Sabadell	Spain
Hyfurmfi Dr Lw Sjpxl Czos I Smvr Psf	Barcelona	Spain
Hdeunslu Vyke dlpypgwf	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	29.03.2023

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a medication used in this trial to help the immune system attack cancer cells. It works by blocking a protein that prevents the immune system from effectively targeting and destroying cancer cells. In this study, it is used in combination with other treatments to see if it can help achieve complete remission in patients with anal canal cancer.

Tiragolumab is another medication being tested in this trial. It is designed to enhance the immune response against cancer cells. By working together with atezolizumab, it aims to improve the body’s ability to fight the cancer more effectively.

Chemoradiotherapy is a standard treatment that combines chemotherapy and radiation therapy. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while radiation therapy uses high-energy rays to target and destroy cancer cells. In this trial, chemoradiotherapy is used alongside atezolizumab and tiragolumab to evaluate if the combination can lead to better outcomes for patients with anal canal cancer.

Squamous Cell Carcinoma of the Anal Canal – This is a type of cancer that begins in the squamous cells lining the anal canal. It typically develops slowly and may initially present as a small growth or sore in the anal area. As the disease progresses, it can cause symptoms such as pain, bleeding, or changes in bowel habits. The cancer may spread to nearby tissues or lymph nodes if not addressed. It is often associated with certain risk factors, including human papillomavirus (HPV) infection. Early detection and monitoring are crucial for managing its progression.

Trial ID:

2023-509485-38-00

Protocol code:

GEMCAD – 2103//MO4

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Atezolizumab and Tiragolumab with Chemoradiotherapy for Patients with Localized Anal Canal Squamous Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?