Study on the Safety and Effectiveness of Atezolizumab with Thiopurine Therapy for Patients with Advanced or Metastatic Solid Tumors

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What is this study about?

This clinical trial is focused on studying advanced and/or metastatic solid tumors, which are types of cancer that have spread to other parts of the body. The study is investigating the effects of a treatment combination that includes Atezolizumab, a medication that helps the immune system fight cancer, and two chemotherapy drugs, Mercaptopurine and Thioguanine. These medications are being tested together to see if they can work more effectively against these types of cancers.

The purpose of the study is to determine the safety, tolerability, and effectiveness of this combination treatment. Participants will receive the medications either by infusion, which is a method of delivering drugs directly into the bloodstream, or orally, which means taking the medication by mouth. The study will monitor how well the treatment works in shrinking tumors and how long it can keep the cancer from getting worse.

Throughout the study, researchers will also look at how the treatment affects the immune system and the genetic makeup of the tumors. This includes examining changes in the tumor’s DNA and how these changes might predict the treatment’s success. The study aims to provide valuable information that could lead to better treatment options for patients with advanced solid tumors.

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.

Blood tests and imaging studies are performed to evaluate the current state of the disease.

2 treatment initiation

The treatment phase begins with the administration of atezolizumab, a medication given through an infusion. This is combined with oral medications mercaptopurine and tioguanine.

The infusion of atezolizumab is typically administered every three weeks, while mercaptopurine and tioguanine are taken orally on a daily basis.

3 monitoring and evaluation

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes blood tests, imaging studies, and physical examinations.

The response to treatment is evaluated using specific criteria to measure changes in the size of the tumor.

4 biopsy and genetic analysis

Biopsies may be performed to obtain tissue samples for genetic analysis. This helps in understanding the tumor’s characteristics and response to treatment.

Blood samples are also collected to analyze circulating tumor DNA and immune cell profiles.

5 follow-up and conclusion

After completing the treatment phase, follow-up visits are scheduled to monitor long-term outcomes and any potential side effects.

The study aims to conclude by January 2026, with ongoing assessments to determine the overall effectiveness and safety of the treatment.

Who Can Join the Study?

Signed written informed consent: You must agree in writing to participate in the study.
Ability to take oral medications: You must be able to swallow pills or tablets.
Women of childbearing potential must have a negative pregnancy test within 5 days before starting the study medication.
Men and women who can have children must agree to use a highly effective method of birth control during the study and for 5 months after stopping the study medication. Women should not donate eggs, and men should not donate sperm during this time.
Age 18 years or older.
Performance status (WHO) of 0-1: This means you should be fully active or have some symptoms but still be able to carry out light work.
Histologically confirmed advanced and/or metastatic solid tumors: You must have a type of cancer that has been confirmed by a tissue sample and is advanced or has spread to other parts of the body, with no standard cure available.
Radiologically measurable disease according to RECIST v1.1: Your cancer must be visible and measurable on scans according to specific guidelines.
Life expectancy estimated by the Investigator to be 12 weeks or more.
Metastatic Lesion(s) or primary tumor accessible for biopsy: The cancer must be in a location that can be safely sampled for testing.
Intermediate tumor mutational burden of 5-10 mutations/mb: Your cancer should have a moderate number of genetic changes.
Adequate organ function as shown by specific blood test results:
- Absolute lymphocyte count of at least 0.5 x 10⁹/L
- Neutrophils of at least 1.5 x 10⁹/L
- Platelets of at least 100 x 10⁹/L (or 65 x 10⁹/L for certain liver cancer patients)
- Hemoglobin of at least 90 g/L (5.6 mmol/L) and at least 4 weeks since last blood transfusion
- Serum creatinine of 1.5 times the upper limit of normal or better, or a creatinine clearance of at least 50 mL/min
- AST (a liver enzyme) of 3 times the upper limit of normal or less, or 5 times if there is liver involvement
- Bilirubin of 1.5 times the upper limit of normal or less, except for patients with Gilbert’s syndrome, who must have total bilirubin less than 3.0 mg/dL

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have medical conditions that could interfere with the study treatment.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are recovering from one.
Patients who have an active infection that requires treatment.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to the study drugs.
Patients who have a condition that affects their immune system, making them more vulnerable to infections.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.02.2022

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this trial to help the body’s immune system fight cancer. It works by blocking a protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

Thiopurine Therapy involves the use of medications that can suppress the immune system. In this trial, thiopurine therapy is combined with Atezolizumab to see if it can enhance the effectiveness of the immune response against cancer cells.

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, or pancreas. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body. The progression of these tumors can lead to a range of symptoms depending on their location and size. They are often characterized by their ability to resist standard treatments and may require more aggressive therapeutic approaches.

Trial ID:

2024-517307-37-00

NCT ID:

NCT05276284

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effectiveness of Atezolizumab with Thiopurine Therapy for Patients with Advanced or Metastatic Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?