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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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 49 most recent of 165 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor Study sites: 338 to 339
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  3. Minor Site details revised at 2 of 337 sites
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  1. Minor Changed Trial sites expanded: 327 → 332 locations
  2. Minor Site details revised at 2 of 327 sitesv157
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  15. Minor Site details revised at 4 of 311 sitesv144
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  21. Minor Site details revised at 1 of 296 sitesv138
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    • Trial sites expanded: 261 → 266 locations
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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.
Trial Details
NCT Number NCT07061977
Lead Sponsor National Cancer Institute (NCI)
Conditions 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
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov