Study of Tislelizumab, Pamiparib, and Ociperlimab in Patients with Advanced Solid Tumors and Blood Cancers

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What is this study about?

This clinical trial is focused on studying treatments for patients with advanced malignancies, which include both solid tumors and hematological malignancies (cancers that affect the blood, bone marrow, and lymph nodes). The study involves the use of several investigational drugs, including Tislelizumab, Pamiparib, and Ociperlimab. Tislelizumab is administered as a concentrate for solution for infusion, meaning it is given through a vein. Pamiparib is taken orally in capsule form, and Ociperlimab is provided as a solution for infusion.

The purpose of this study is to evaluate the long-term safety of these investigational drugs in patients with advanced cancers. Participants in this study are those who are already part of a related study and continue to benefit from the treatment. The study will monitor the safety of the treatments by observing any side effects, especially those that are serious or affect vital organs like the heart, liver, or brain. The study will also look at overall survival, which is the time from the start of treatment until death from any cause.

During the study, participants will receive the investigational drugs over a period, with the maximum treatment period for some drugs being up to 178 days. The study aims to ensure that the treatments are safe for long-term use and to gather more information on their effects. Participants will be closely monitored throughout the study to ensure their safety and well-being.

1 joining the study

Participation begins after joining a BeiGene-sponsored parent study. Eligibility is confirmed based on the criteria of the parent study.

A signed informed consent form is required before starting the study treatment.

2 initial treatment phase

The first dose of study treatment is administered within the allowed treatment interruption period from the parent study.

The treatment involves the use of investigational drugs such as tislelizumab and pamiparib.

3 medication administration

Tislelizumab is given as an intravenous infusion. The frequency and dosage are determined by the study protocol.

Pamiparib is administered orally in capsule form. The frequency and dosage are specified in the study protocol.

4 monitoring and assessments

Regular monitoring is conducted to assess the safety of the investigational drugs. This includes checking for any adverse effects.

Assessments focus on the incidence of adverse events, especially those affecting vital organs or leading to changes in medication.

5 long-term safety evaluation

The main objective is to evaluate the long-term safety of the investigational drugs in patients with advanced malignancies.

Safety is assessed by tracking adverse events and overall survival from the start of treatment in the parent study.

6 study completion

The study is estimated to end by August 31, 2024.

Completion involves a final assessment of the patient’s condition and any long-term effects of the treatment.

Who Can Join the Study?

Currently participating in a BeiGene-sponsored eligible parent study.
Meets the treatment criteria specified in the parent study protocol.
The study doctor believes the patient will continue to benefit from and tolerate any of the treatments from the parent study.
The first dose of study treatment in this study will be received within the allowed break period from the parent study.
Female patients who can have children and female partners of non-sterile males must use highly effective birth control methods before starting the study treatment, during the study, and after the last dose of study treatment.
Male patients are eligible if they are abstinent, have had a vasectomy, or agree to use contraception during the study and after the last dose of study treatment. Non-sterile males receiving investigational drugs or other treatments that can affect genes must avoid donating sperm during the study and after the last dose of study treatment.
A signed informed consent form must be obtained before enrolling in this study and receiving study treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied, which are solid tumors (a mass of tissue that is not liquid) and hematological malignancies (cancers that start in blood-forming tissue).
Patients who are not within the specified age range for the study.
Patients who are not part of the specific group being studied.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hopital Beaujon	Clichy	France
Hopital Prive Jean Mermoz	Lyon	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Iwumoeyd Rklglaxg Dg Calslg Dc Mphfvrbsfff	Montpellier	France
Sqxbyunr Pahlkmxbn Sru z oglh	Gdynia	Poland
Npoblbbk Ibyhqeap Obtcofpzl Ilk Myvsg Svvfgrehtfpjsydozjdqacrintrv Ihghjpai Bbqulitx	Cracow	Poland
Abwnbeq Uzurg Swyavyfge Lyhxsv Dl Bayquii	Bologna	Italy

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.04.2021
Italy	Not recruiting	08.04.2021
Poland	Not recruiting	08.04.2021

Trial locations

Investigated drugs:

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

Pamiparib is another medication involved in the trial, which is used to treat cancer by interfering with the cancer cells’ ability to repair their DNA. This can lead to the death of cancer cells and help slow down or stop the growth of tumors.

Other Investigational Agents are also part of the trial. These are new drugs that are being tested to see how well they work in treating advanced cancers. The specific details of these agents are not provided, but they are being studied to understand their potential benefits and safety in cancer treatment.

Investigated diseases:

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, such as the breast, lung, prostate, or colon. These tumors grow as a result of uncontrolled cell division and can invade nearby tissues. Over time, they may spread to other parts of the body through the bloodstream or lymphatic system. The progression of solid tumors can vary greatly depending on the type and location of the tumor. They are typically classified based on the type of cells they originate from, such as carcinomas or sarcomas.

Hematological Malignancies – Hematological malignancies are cancers that begin in the blood-forming tissue, such as the bone marrow, or in the cells of the immune system. These include leukemia, lymphoma, and myeloma, which affect the production and function of blood cells. The disease often leads to the overproduction of abnormal blood cells, which can crowd out normal cells and impair the body’s ability to fight infections, carry oxygen, or control bleeding. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression and symptoms can vary widely depending on the specific type of hematological malignancy. They are often characterized by symptoms such as fatigue, fever, and frequent infections.

Trial ID:

2023-508883-31-00

Protocol code:

BGB-A317-290-LTE1

NCT ID:

NCT04164199

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Tislelizumab, Pamiparib, and Ociperlimab in Patients with Advanced Solid Tumors and Blood Cancers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?