Actively Recruiting
A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia
Led by Imperial College London · Updated on 2024-04-17
20
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
C
Cancer Research UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility of using pembrolizumab, an immunotherapy drug, before surgery in patients with post-molar gestational trophoblastic neoplasia (GTN), a rare pregnancy-related condition involving abnormal growth of placental cells. The study focuses on patients with low-risk, recurrent GTN who have not responded fully to initial surgical treatment. By exploring pembrolizumab as a less toxic alternative to chemotherapy, the trial hopes to find safer treatment options for these patients. Participants will be randomly assigned to one of two groups: one group will receive a second surgical removal alone, while the other will receive a single intravenous dose of pembrolizumab followed by surgery. Twenty patients in total will be recruited and evenly divided between these two groups. The study will take place at a single hospital and will include follow-up monitoring for one year after surgery. During the study, participants will undergo assessments including blood tests to measure hormone levels, imaging tests such as chest X-rays to check for disease spread, and evaluations of overall health and organ function. The main goal is to determine if delivering pembrolizumab before surgery is practical and acceptable. Researchers will also monitor the safety of this approach and compare the rates of surgical cure between the two groups. Participants' health will be tracked for up to one year following treatment.
CONDITIONS
Brief Title
A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and agree to follow the study schedule.
- Be 18 years of age or older.
- Have postmolar gestational trophoblastic neoplasia confirmed by tissue examination after primary surgery with no other treatment in between.
- Have plateaued or rising human chorionic gonadotropin (hCG) levels as defined by study criteria.
- Have hCG levels under 20,000 IU/L.
- Have low risk disease with a FIGO score of 6 or less.
- Have no metastatic disease visible on chest X-ray.
- Have an ECOG performance status of 0 or 1.
- Have disease located within the uterine cavity and not within 5mm of the uterine outer surface.
- Have adequate bone marrow and organ function based on blood counts and lab tests.
- Agree to use a highly effective contraception method or complete abstinence for 1 year following second surgery.
You will not qualify if you...
- Have invasive cancers other than non-melanoma skin cancer within the last 2 years or treatments that prevent study therapy.
- Have choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor confirmed at first curettage.
- Be currently pregnant.
- Have uncontrolled vaginal bleeding.
- Have received live vaccines within 30 days before the study drug.
- Have a history of immunodeficiency or recent immunosuppressive therapy.
- Have active autoimmune disease requiring systemic treatment in past 2 years.
- Have history or current pneumonitis needing steroids.
- Have HIV infection.
- Have known active Hepatitis B or C infection.
- Have history of active tuberculosis.
- Have any condition or therapy that may interfere with study participation or results.
- Have history of allogenic tissue or solid organ transplant.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short-term treatment period before second evacuation
Participants receive either a single intravenous dose of Pembrolizumab prior to a second evacuation procedure or second evacuation alone according to randomization.
2 visits (1 for Pembrolizumab administration and 1 for second evacuation)
Duration - Up to 1 year
Participants are monitored to assess surgical cure rates and safety outcomes after treatment.
Visits scheduled during the 12 weeks post-treatment and additional assessments up to 1 year
Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Actively Recruiting
Research Team
A
Aaron Clarke
P
Philip Badman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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