SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma
Last Update Posted : 2023-09-18
The aim of the trial
- The aim of this study is to see how effective the drug regorafenib is in combination with the drug nivolumab in treating patients with recurring osteosarcoma. There is one group in this trial.
- Country
- United States,
- Locations
- Los Angeles, Miami, Baltimore, Ann Arbor, Minneapolis, Cincinnati, Portland, Dallas,
- Trial Type
- Interventional
- Trial Phase
- Phase 2,
- Trial Status
- Active, not recruiting
- Minimum age
- 5 Years
- Maximum age
- -
- Key Contact
- ----
- Clinical Trial ID
- NCT04803877
Key Information
- As there is only one group in this study, everyone will receive some form of treatment. The dosage of regorafenib and nivolumab will vary between participants based on age.
How the treatment works
- Regorafenib is a Tyrosine kinase inhibitor (TKI). TKIs work by blocking the activation of enzymes known as tyrosine kinases. Tyrosine kinases are involved in multiple processes in the body and are also involved in cancer growth. By blocking their activity TKIs can prevent cancer cells from growing and dividing. There are many different types of TKIs. TKIs are usually given as tablets although they can also be given as an injection or a drip through a vein. Side effects include tiredness, loss of appetite, and diarrhoea. Each TKI will also have its own specific side effects that a doctor will explain before you start on one. TKIs are currently licenced for use in some cancers and are being tested in clinical trials to treat osteosarcoma.
- Nivolumab is a monoclonal antibody (MAB). Antibodies are part of the immune system and are found naturally in the body. They recognise markers on the surface of foreign cells and bind to them. MABs work in a similar way to naturally occurring antibodies however they have a more targeted approach. Antibodies are modified in the lab to target one specific cell marker. For example a marker on cancer cells. Once in the body, they will bind to cells expressing that marker and lead to its destruction. Researchers are able to identify what markers are expressed on cancer cells and modify MABs to target them. MABs are usually given as a drip directly into a vein. General side effects include tiredness, diarrhoea, and flu-like symptoms. However, each type of MAB has its own specific side effects which your doctors will discuss before you agree to treatment. MABs are approved for use in a range of different cancers. They are also being tested in clinical trials.
- Visit our drugs and interventions page to find out more about this treatment, including how it works and what it’s used for.
Who is the trial for?
- The below points are a summary of who can enter the trial.
- People must be over 5 years of age. Every effort will be made to ensure that half of the patients will be less than 21 years of age.
- People who have had a sample of tumour analysed to confirm the diagnosis of osteosarcoma. The osteosarcoma must be high grade that has not responded to treatment. People who have cancer that has spread to other parts of the body are also eligible.
- Performance Status: Lansky (≤ 16 years of age) or Karnofsky (>16 years of age) performance score of ≥ 70, or Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1. Your doctor will know this.
- People with osteosarcoma that can be measured by an imaging scan. The imaging must be performed within 21 days of the first day of receiving treatment in the trial.
- People must be able to swallow pills.
- People with adequate, kidney liver, lung, heart and bone marrow function. You will have tests to check this.
- People who do not have an irregular heartbeat (arrhythmia), stroke of heart attack within 6 months prior to the start of the trial.
- People who have had previous anti-cancer treatment must have finished the treatment before taking part in this trial. More details are available on clinicaltrial.gov.
- People of childbearing potential must provide a negative pregnancy test less than 7 days prior to Day 1 of the study. They must also follow the contraceptive guidance given during the treatment period and for at least 5 months or 8 weeks (depending on the treatment received) after the last dose of treatment in the study.
- People with brain and spinal cord disease are eligible if they have received prior radiotherapy and are without evidence of disease progression for at least 4 weeks after treatment. Your doctor will know this.
Who is the trial not for?
- The below points are a summary of who can’t enter the trial.
- People with any previous or current other cancer or medical condition that may put them at risk or affect the trial. The trial team will discuss this.
- People who are pregnant or breastfeeding.
- People who have received any major surgery or have had a significant injury within 4 weeks of the start of the trial
- People with a known sensitivity to any of the drug components.
- People with cancer that has spread to the brain or spinal cord.
- People who have previously taken an immune checkpoint inhibitor or a tyrosine kinase inhibitor targeting VEGF. Your doctor will know this.
- Patients with autoimmune disease
- People who take immunosuppressive drugs.
- People who have received any other drug in another trial within 4 weeks of the start of this trial.
- People with any uncontrolled infection.
- People with active HIV, hepatitis B or hepatitis C. People taking effective anti-retroviral therapy for HIV with undetectable viral load within 6 months are eligible for this trial.
- People who have previously received a stem cell, bone marrow or organ transplant.
- People with uncontrolled high blood pressure.
- People who required blood clotting treatment.
- People who have a non-healing wound, non-healing ulcer or fracture.
- People who have fluid in the lungs or stomach that causes breathing difficulties.
- People who have an active gastrointestinal disorder with diarrhea as a major symptom. Your doctor will know this.
- People who are taking steroids or immune suppressing drugs.
- People who have had a vaccine within 30 days of the start of the trial.
- People taking CYP3A4 inhibitors or inducers. Your doctor will know this.
- People who have had any hemorrhage or bleeding event CTCAE ≥ Grade 3 within 28 days of the start of the study. Your doctor will know this.
- People with a Body surface area (BSA) < 0.4 m2. Your doctor will know this.
Disclaimer
- ONTEX is intended to supplement, not replace, your healthcare team. Patients should always discuss a clinical trial with their healthcare team. If a patient is eligible for a trial the trial team will be able to provide more in-depth information about the trial so the patient can make an informed decision before taking part. Trial information has been sourced from www.clinicaltrials.gov. The content is then reviewed weekly by the Osteosarcoma Now team. All the trials also have a patient-friendly summary and key information section written by the team at Osteosarcoma Now. We have also included a description of the medications being used in the trial and summarised the inclusion and exclusion criteria in the ‘who is this trial (not) for’ sections. To the best of our knowledge the clinical trial database is up-to-date and accurate.However, we cannot assume any liability for the accuracy or completeness of the information.