Pembrolizumab and Chemotherapy for High-Risk Cervical Cancer

Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer

Recruiting Phase 3 Interventional Study
Locally Advanced Cervical Adenocarcinoma Locally Advanced Cervical Adenosquamous Carcinoma Locally Advanced Cervical Squamous Cell Carcinoma Stage IIIA Cervical Cancer FIGO 2018 Stage IIIB Cervical Cancer FIGO 2018 Stage IIIC1 Cervical Cancer FIGO 2018 Stage IIIC2 Cervical Cancer FIGO 2018 Stage IVA Cervical Cancer FIGO 2018
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
336 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for individuals with advanced cervical cancer who have not received prior treatment. Participants will receive a combination of chemotherapy and an immunotherapy drug to see if it helps improve their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with cervical cancer.
  • I have locally advanced cervical cancer.
  • I am at least 18 years old.
  • I have not received prior treatment for cervical cancer.
  • I have adequate blood counts and liver function.
  • I have no current infections.
  • I am not pregnant or nursing.

You may not be able to join if

  • I have had pelvic radiation before.
  • I have a history of heart disease.
  • I have received other immunotherapy treatments.
  • I have an active autoimmune disease.
  • I have had a severe allergic reaction to similar medications.
  • I am currently taking chronic immunosuppressive therapy.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-co…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma * Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymp…
Contacts

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