Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05635344

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

128 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

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.

CONDITIONS

Official Title

A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent and ability to follow study schedule
  • Age 18 years or older
  • Postmolar GTN confirmed by histology after initial surgical evacuation with no treatment in between
  • Plateau or rising hCG levels as defined by study criteria
  • hCG levels under 20,000 IU/L
  • Low risk disease with FIGO score of 6 or less
  • No metastatic disease on chest X-ray
  • ECOG performance status of 0 or 1
  • Disease present in uterine cavity, not within 5mm of serosal surface
  • Adequate bone marrow and organ function as defined by specified lab values
  • Agree to highly effective contraception or complete abstinence for 1 year after second surgery
Not Eligible

You will not qualify if you...

  • Other invasive cancers within last 2 years except non-melanoma skin cancer
  • Histologically confirmed choriocarcinoma, PSTT, or ETT on first curettage
  • Pregnancy
  • Uncontrolled vaginal bleeding
  • Live vaccine administration within 30 days prior to study drug
  • History of immunodeficiency or recent immunosuppressive therapy
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History or current pneumonitis requiring steroids
  • HIV infection
  • Known active Hepatitis B or C infections
  • History of active tuberculosis
  • Conditions or therapies interfering with study participation or results
  • History of allogenic tissue or organ transplant

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Trial Site Locations

Total: 1 location

1

Imperial College Healthcare NHS Trust

London, United Kingdom, W6 8RF

Actively Recruiting

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Research Team

A

Aaron Clarke

CONTACT

P

Philip Badman

CONTACT

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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