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A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs. Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer - Clinical Trial

Jeremy G. Price, MD, PhD

Study Summary

This is a randomized, phase 3, multicenter trial designed to determine if induction weekly chemotherapy, when added to standard concurrent chemoradiotherapy and immunotherapy, for locally advanced cervical cancers can improve disease control and cure rate. The outcome for this study will be assessed over the first 2-3 years following completion of the therapy to which the patient is randomized. 

ClinicalTrials.gov ID: NCT07061977

Protocol: 26-2002

Phase: III

Investigator: Jeremy G. Price, MD, PhD

Disease(s): Cervical Cancer

Full description:

Visit ClinicalTrials.gov for a full clinical trial description

Location(s): Fox Chase Cancer Center at Cottman Ave

Inclusion/Exclusion Criteria:  

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About This Trial:

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515 or fill out this form.

  • 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 lymph node involvement:
    • IIIA (T3aN0M0)
    • IIIB (T3bN0M0)
    • IIIC1(T3aN1M0, T3bN1M0)
    • IIIC2 (T3aN2M0, T3bN2M0)
    • IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.
      • NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.
  • No paraaortic lymph node (PALN) metastases above the T12/L1 interspace.

Concurrent chemoradiation therapy (CCRT) is the standard of care for locally advanced cervical cancer (LACC); however, outcomes remain suboptimal in patients with high-risk disease. Recent studies suggest that integration of immunotherapy (IO) with definitive chemoradiation, or induction chemotherapy prior to CCRT improves outcomes. Whether treatment intensification with induction systemic therapy and IO prior to CCRT and IO further improves disease control remains unknown. Induction chemotherapy may reduce tumor burden, eradicate micrometastatic disease, and improve tumor immunogenicity prior to definitive CCRT. Preclinical and clinical data support synergy between systemic therapy or radiotherapy and immune checkpoint blockade, providing the rationale for evaluating an induction strategy incorporating chemotherapy and immunotherapy before standard CCRT with immunotherapy, followed by maintenance immunotherapy. Optional tumor tissue and blood samples will be collected for exploratory correlative analyses, including immune and molecular biomarkers associated with response, resistance, and patterns of failure.

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515.