Clinical Trials Directory
For this type of cancer, standard treatment includes radiation therapy along with chemotherapy medicines such as carboplatin and paclitaxel. In this study, people will also receive extra chemotherapy for up to six months after the standard treatment is finished. This extra treatment is called consolidation chemotherapy. It uses common cancer medicines such as fluorouracil, leucovorin, oxaliplatin, and docetaxel. Some people may also receive a medicine called durvalumab, which helps the immune system fight cancer.
We are doing this study to find out if an experimental drug called TORL-1-23 (the study drug) is a safe and effective option for women who have advanced ovarian cancer, primary peritoneal, or fallopian tube cancer.
People in this study may get up to 8 treatment cycles. Each cycle lasts 21 days. Usually, there are 3 to 4 cycles before surgery and 2 to 4 cycles after surgery, depending on how the cancer responds and what the doctor decides. The whole treatment takes about 8 months, and doctors will check on patients for up to 15 more months. This means the study lasts about 24 months in total. Doctors will place patients into one of three groups (A, B, or C). This is not random. All groups will get a medicine called TORL 123. Group A: TORL 123 plus paclitaxel Group B: TORL 123 plus carboplatin Group C: TORL 123 plus both paclitaxel and carboplatin Medicine is given through an IV on Day 1 of each cycle. There will also be extra visits and blood tests during the cycle.
This study includes one virtual information session, some online questionnaires, five in person visits, and a twelve week exercise program that is supervised from home. All in person visits will happen at the Duke Center for Living in Durham. The exercise program includes both aerobic exercise and strength training. Each week there will be Zoom exercise classes led by a study staff member, along with workouts you complete on your own using materials the study provides.
In this study, you will have three devices used on the outside of your body to measure how your heart is working, your blood pressure, and the pressure inside your heart. During your procedure, a thin tube will also be placed into a vein in your heart called the coronary sinus. It will be gently moved into the lower part of your heart to take measurements. Your heart will then be paced, and the measurements will be taken again. These extra steps will add about twenty minutes to your procedure.
This study has two parts. In the first part, people will take a new study medicine called TRI 611 by itself every day in treatment cycles that last 28 days. Researchers will test different dose levels to find the safest and best amount of the medicine. The dose may change during the study based on safety results and how people respond. In the second part, more people will receive dose levels that were already tested in the first part. Participants will be placed into different study groups and continue taking TRI 611 so researchers can learn more about its safety and how well it works. During the study, doctors will closely monitor participants and check how their cancer responds to the treatment.
In this study, people will first have tests to see if they can join. If they qualify, they will be placed by chance into one of two groups. One group will receive a medicine called JNJ 79635322, and the other group will receive a medicine called teclistamab. Both medicines are given as shots under the skin. At the start, people will receive smaller doses that slowly increase, followed by regular treatment given in cycles that last 28 days. During the study, participants will have clinic visits for checkups, blood tests, urine tests, scans, and sometimes bone marrow tests. After the first doses, people may need to stay near the clinic for a short time and have someone with them to help. The study may last for several years, including time for treatment and follow up visits to check health.