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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Peter
Hoskin
+44 (0)1614 468279
peterhoskin@nhs.net
Prof
Peter
Hoskin
+44 (0)1614 468279
peterhoskin@nhs.net
Mrs
Marina
Lee
+44 (0)2381 205154
crain@soton.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Adenocarcinoma or squamous cell carcinoma of the cervix
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
Cervical cancer affects over 3,000 women a year in the UK. Half of these women are below the age of 45 years. With current treatment, 1 in 3 women will die within 5 years. Current treatment for advanced cervical cancer combines external radiotherapy and chemotherapy (chemoradiation) followed by internal radiotherapy (brachytherapy). The chemotherapy agent used is cisplatin. The drug to be tested, tolinapant, works by blocking the activity of certain proteins that help cancer cells to survive. These proteins can cause cancer cells to die (known as apoptosis). The purpose of this study is to find the best dose of tolinapant to use with radiotherapy. This trial will also look at the side effects of this drug and ensure that the combination is worthwhile.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38849715/ (added 11/06/2024)
You can take part if:
You may not be able to take part if:
1. Previous pelvic radiotherapy2. Liver cirrhosis, or chronic liver disease Child-Pugh Class B or C3. Pregnancy or breastfeeding (Women of child bearing potential (WOCBP) must have a negative serum pregnancy test at screening)4. Patients of child-bearing potential who are not able to use a highly effective method of contraception5. Any investigational medicinal product (IMP) within 30 days prior to consent6. Major surgery within 30 days prior to enrolment7. Hypersensitivity to tolinapant, excipients of the drug product, or other components of the study treatment regimen8. Patients with known HIV infection9. Patients with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody and the absence of HBsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA10. Coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable arrhythmias, unstable angina, left bundle branch block, third-degree heart block, pacemakers or congestive cardiac failure (New York Heart Association ≥ grade 2) within 6 months prior to enrolment11. Any patient who has received a live vaccine within 4 weeks of initiation of their treatment (COVID-19 vaccination is allowed)12. Conditions requiring systemic treatment with either corticosteroid (≥ 20 mg daily prednisolone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. 13. Prior anticancer treatments or therapies within the indicated time window prior to the first dose of study treatment (tolinapant), as follows:13.1.Cytotoxic chemotherapy or radiotherapy within 3 weeks prior and any encountered treatment-related toxicities (excepting alopecia) not resolved to Grade 1 or less.13.2. Skin-directed treatments, including topicals and radiation within 2 weeks prior13.3. Monoclonal antibodies within 4 weeks prior and any encountered treatment-related toxicities not resolved to Grade 1 or less13.4. Small molecules or biologics (investigational or approved) within the longer of 2 weeks or 5 half-lives prior to study treatment and any encountered treatment-related toxicities not resolved to Grade 1 or less13.5. At least 6 weeks must have elapsed since CAR-T infusion and subjects must have experienced disease progression, and not have residual circulating CAR-T cells in peripheral blood (based on a local assessment). Any encountered treatment-related toxicities must have resolved to Grade ≤1.14. Patients taking a QT-prolonging agent15. Use of a concomitant medication which is a strong CYP3A4 inhibitor16. Abnormal left ventricular ejection fraction (LVEF) of <50% on echocardiogram (ECHO)17. History of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy18. Screening 12-lead electrocardiogram (ECG) with measurable QTc interval of ≥470 msec (according to either Fridericia’s or Bazett’s correction)19. Any other active malignancy
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Peter
Hoskin
+44 (0)1614 468279
peterhoskin@nhs.net
Mrs
Marina
Lee
+44 (0)2381 205154
crain@soton.ac.uk
Prof
Peter
Hoskin
+44 (0)1614 468279
peterhoskin@nhs.net
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Southampton and funded by Cancer Research UK.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 51584
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
