Study on Anti-CTLA4-NF mAb, Nivolumab, and Targeted Radiation Therapy for Treating Metastatic Solid Tumors
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT04785287
This clinical trial is exploring the safety and effects of combining two immunotherapy drugs, anti-CTLA4-NF mAb and nivolumab, with targeted radiation therapy to treat solid tumors that have spread to other parts of the body.
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Program Overview
The study aims to find out if using a combination of two immunotherapy drugs, anti-CTLA4-NF mAb and nivolumab, along with precise radiation therapy, can safely and effectively treat metastatic solid tumors. These treatments may help the immune system attack cancer cells and prevent them from growing and spreading. The radiation therapy targets tumors with high precision, potentially reducing the number of treatments needed and minimizing damage to healthy tissue.
Description
The main goal of this study is to evaluate the safety of using the drug anti-CTLA4-NF mAb, either alone or with nivolumab, in combination with targeted radiation therapy for patients with metastatic cancers. Researchers will also look at how well this treatment works in shrinking tumors that are not directly targeted by radiation.
Patients will be divided into two groups. In the first group, patients will receive the anti-CTLA4-NF mAb drug through an IV every 28 days for up to four cycles, along with targeted radiation therapy. In the second group, patients will receive the same treatment as the first group, but will also receive nivolumab starting in the second cycle. This treatment will continue every 28 days for up to two years, as long as the cancer does not progress and side effects are manageable.
After completing the treatment, patients will have follow-up visits at 30 and 60 days, and then at 6 and 12 months to monitor their health and the effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of metastatic solid cancer with at least one tumor in the bone, adrenal gland, liver, or lung.
- Must have completed previous cancer treatments and waited a specified time before joining the study.
- Must have at least one tumor that can be treated with radiation therapy.
- Must be 18 years or older.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during and after the study.
- Men must agree to use condoms and avoid donating sperm during and after the study.
- Must have a good performance status and normal organ function based on specific medical tests.
- Must be willing to provide written consent and follow study procedures.
- Patients with stable brain metastases may participate if they meet certain conditions.
Exclusion Criteria
- Have active or suspected autoimmune disorders or conditions that could worsen with treatment.
- Have certain medical conditions like active infections, heart problems, or psychiatric issues that could interfere with the study.
- Have a positive test for HIV or hepatitis B, or an active hepatitis C infection.
- Have received certain vaccines or treatments that could affect the immune system recently.
- Have a history of severe reactions to similar treatments or have received similar drugs before without success.
- Have a very low lymphocyte count.
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