At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pembrolizumab (drug)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- Pembrolizumab — drug: Single dose 200mg dose of Pembrolizumab given intravenously
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 20
- Started
- 2024-02-14
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for gestational trophoblastic disease
- • Phase2 - 20 participants
- • Gestational Trophoblastic Diseases (GTD) are a variety of rare, pregnancy related cell multiplication disorders of cells of the placenta which can range from pre-cancerous growths to more serious lesions that can spread to nearby tissues that can cause serious health issues
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with gestational trophoblastic disease
- • Female only
Where?
- • London - Imperial College Healthcare NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Gestational Trophoblastic Diseases (GTD) are a variety of rare, pregnancy related cell multiplication disorders of cells of the placenta which can range from pre-cancerous growths to more serious lesions that can spread to nearby tissues that can cause serious health issues. Most patients that develop GTD are diagnosed at the precancerous stage early in pregnancy and undergo surgical removal of the disease from the uterus. Around 15% of patients are not cured by surgical removal alone and need to undergo further treatment with chemotherapy or further surgery; of which roughly one-third of patients are cured with a second round of surgery alone. Anti-cancer treatment with chemotherapy carries many short- and long-term side effects that can negatively affect a person's quality of living. Finding less harmful anticancer therapies that can be paired with surgery is therefore of great benefit to patients with recurrent GTD. An alternative is to pair surgery with another class of anticancer treatments, known as immunotherapies. Immunotherapy aims to encourage the bodies natural defences to fight the cancer cells. Pembrolizumab, an immunotherapeutic agent which works by preventing cancer cells from hiding from the immune system; has been proven to be an extremely safe form of anticancer therapy and is an attractive alternative to more toxic chemotherapeutic agents. The RESOLVE study aims to determine how feasible it is to deliver pre-surgical pembrolizumab to patients and determine if this is a desirable alternative; potentially leading to a larger more definitive study. 20 patients will be recruited onto the study and will be evenly split into two arms: * 10 patients to receive second evacuation alone * 10 patients to receive single dose of Pembrolizumab followed by surgery All patients that take part in the study will be recruited from Charing Cross Hospital and will be followed up for a year after the date of their surgery.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓Written agreement to take part prior to initiation of any study procedures and willingness and ability to comply with the...
- ✓Age ≥18yrs
- ✓Postmolar GTN defined as recurrence or persistence of confirmed by a biopsy CHM after primary surgical evacuation...
- ✓hCG under 20,000 IU/L
- ✓Low risk disease as defined by the Federation of Obstetrics and Gynecology (FIGO) 2000 risk scoring criteria (score...
Who cannot take part
- ✗Patients with confirmed by a biopsy choriocarcinoma, placental site trophoblastic tumor (PSTT) or epithelioid...
- ✗Pregnant women.
- ✗Uncontrolled vaginal bleeding.
- ✗History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- ✗History of Human Immunodeficiency Virus (HIV) infection.
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust
London W6 8RF, United Kingdom
How to Get in Touch
Aaron Clarke
Sponsor contactCONTACT
Philip Badman
Sponsor contactCONTACT
