Study of INCB099280 and Ipilimumab for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment combination for people with certain types of solid tumors, which are abnormal masses of tissue that can occur in various parts of the body. The study involves two treatments: a medication with the code name INCB099280, which is taken as a film-coated tablet, and Ipilimumab, known by the brand name YERVOY, which is given as an infusion directly into the bloodstream. The purpose of the study is to determine how safe and tolerable this combination is for patients with advanced solid tumors.

Participants in the study will receive the treatment combination over a period of time, with INCB099280 being taken orally and Ipilimumab administered through an intravenous infusion. The study will monitor the participants for any side effects or reactions to the treatment. The goal is to find the right dose that is both safe and effective for patients. The study will also compare the effects of the treatment combination to a placebo to better understand its impact.

Throughout the study, participants will have regular check-ups and tests to assess their health and the progress of their treatment. These tests will help researchers understand how the treatment affects the body and whether it helps control the growth of the tumors. The study is expected to continue for several years, allowing researchers to gather comprehensive data on the treatment’s safety and effectiveness.

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 blood test is performed to ensure all health parameters are within acceptable ranges. A pregnancy test is conducted for women of childbearing potential.

2 treatment initiation

The treatment phase begins with the administration of INCB099280 and ipilimumab. INCB099280 is taken orally in the form of a film-coated tablet.

Ipilimumab is administered through an intravenous infusion. The dosage and frequency are determined by the study protocol and adjusted based on individual tolerance.

3 monitoring and follow-up

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

Participants are observed for any side effects or adverse reactions. Adjustments to the treatment may be made based on these observations.

4 completion of treatment

The treatment phase concludes as per the study timeline or upon reaching the desired outcomes.

A final assessment is conducted to evaluate the overall response to the treatment and to document any lasting effects.

5 post-treatment follow-up

Participants may be required to attend follow-up visits to monitor long-term health outcomes.

These visits help in understanding the prolonged effects of the treatment and ensuring the well-being of the participants.

Who Can Join the Study?

Must be able to understand and willing to sign a written consent form for the study.
Must be 18 years or older at the time of signing the consent form.
Must have had previous treatments, diagnoses, and disease settings as specified in the study protocol.
Must be willing and able to follow all study requirements, including attending all scheduled visits, following study procedures, and being able to swallow pills.
Must have an ECOG performance score of 0 or 1. This score is a way to measure how well a person can perform daily activities.
Must have a life expectancy of more than 3 months, according to the study doctor.
Must have a confirmed diagnosis of solid tumors that can be measured according to specific guidelines (RECIST v1.1).
Must agree to avoid pregnancy or fathering children during the study and for a certain period after the last dose of the study treatment:

Male participants must agree to take precautions to avoid fathering children from the start of the study until 100 days after the last dose and must not donate sperm during this time.
Female participants who can become pregnant must have a negative pregnancy test before starting the study and agree to take precautions to avoid pregnancy from the start of the study until 190 days after the last dose and must not donate eggs during this time.
Female participants who cannot become pregnant are eligible.

Who Cannot Join the Study?

Participants with a type of cancer called a solid tumor are not eligible.
Individuals who are not within the specified age range for the study cannot participate.
Both males and females are eligible, but certain vulnerable populations may be excluded.
Participants who do not meet the safety and tolerability requirements for the study will be excluded.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Vestre Viken HF	Drammen	Norway
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Narodny Onkologicky Ustav	Bratislava	Slovakia
Afqdzvyf Uqhevzshur Hwriqiyb	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.12.2023
Slovakia	Not recruiting	01.12.2023
Sweden	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

INCB099280 is an investigational medication being studied for its potential to treat certain types of solid tumors. It is being tested to see how safe it is for patients and how well it can be tolerated when used in combination with another medication.

Ipilimumab is a medication that helps the immune system fight cancer. It is used in this study to see how it works together with INCB099280 to treat advanced solid tumors.

Investigated diseases:

Solid Tumor – 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, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a lump or mass. As they progress, solid tumors can invade nearby tissues and organs, potentially disrupting their normal function. They may also spread to other parts of the body through the bloodstream or lymphatic system. The growth rate and behavior of solid tumors can vary widely depending on their type and location.

Trial ID:

2023-503243-34-00

Protocol code:

INCB 99280-205

NCT ID:

NCT05909995

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of INCB099280 and Ipilimumab for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?