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Clinical Trial Summary

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. We aim to recruit 20 patients to the study that 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05635344
Study type Interventional
Source Imperial College London
Contact Aaron Clarke
Phone 02033117740
Email aeclarke@ic.ac.uk
Status Not yet recruiting
Phase Phase 2
Start date January 31, 2024
Completion date October 1, 2025

See also
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Recruiting NCT06028672 - Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6 N/A
Not yet recruiting NCT06169644 - The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment
Terminated NCT02664961 - Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN) Phase 2
Withdrawn NCT05405192 - Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia Phase 2
Recruiting NCT03703271 - Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia Phase 3
Not yet recruiting NCT04303884 - Phase 2 Trial for Chemo-Resistant Gestational Trophoblastic Neoplasias With Pembrolizumab (CR-GTP) Phase 2
Recruiting NCT05139095 - Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia Phase 2
Recruiting NCT04756713 - Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia Phase 3
Recruiting NCT03785574 - Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule N/A
Active, not recruiting NCT01823315 - Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia Phase 3
Recruiting NCT04812002 - Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy Phase 2