RESOLVE
Research type
Research Study
Full title
A feasibility window study of pembrolizumab prior to second evacuation for post-molar gestational trophoblastic neoplasia.
IRAS ID
1006984
Contact name
Philip Badman
Contact email
Sponsor organisation
Imperial College London
Eudract number
2022-002986-14
ISRCTN Number
ISRCTN86152317
Clinicaltrials.gov Identifier
Research summary
Gestational Trophoblastic Diseases (GTD) are a group of rare, pregnancy related diseases of the placenta which can range from pre-cancerous growths to cancers that can be fatal if left untreated.
Most patients with GTD are diagnosed at the precancerous stage early in pregnancy and undergo surgical removal of the disease from the womb. Around 15% of patients are not cured by surgical removal alone and need further treatment with chemotherapy or second surgery. Roughly one-third of patients are cured with a second surgery.
Anticancer treatment with chemotherapy carries many short- and long-term side effects that can negatively affect a person’s quality of life. Finding less harmful therapies that can be paired with surgery could therefore be of great benefit to patients with recurrent GTD.
One alternative is to pair surgery with another class of anticancer treatment, known as immunotherapy. Immunotherapy drugs such as pembrolizumab work by activating the body’s natural immune defences to fight the cancer.
Pembrolizumab is an extremely effective and safe treatment for patients with more advanced GTD and an attractive alternative to more toxic chemotherapies.
The RESOLVE study aims to determine how feasible it is to give pembrolizumab prior to second surgery. The study will determine if we are able to recruit patients and if treatment can be safely delivered. On the study, patients will be closely monitored. We will collect tissues that will help us understand better how cancers escape the immune system and how immunotherapy works.
We aim to recruit 20 patients to the study and will evenly split participants into two arms:
• 10 patients to receive second surgery alone
• 10 patients to receive single dose of Pembrolizumab followed by surgery
All patients will be recruited from Charing Cross Hospital and will be followed up for a year after the date of their surgery.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0260
Date of REC Opinion
25 Jul 2023
REC opinion
Further Information Favourable Opinion