Phase 2
Completed N=94
Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer
Source: ClinicalTrials.gov NCT02635360 ↗Enrolled (actual)
94
Serious AEs
71.3%
Results posted
Jul 2025
Primary outcomePrimary: Change in Immunologic Markers Following Combination of Study Drug With Chemoradiation — 31.31; 140.33 ratio of cells per mm^2", "CD8+: FoxP3+
Summary
The purpose of this study is to evaluate the safety and effectiveness of immunotherapy in combination with chemotherapy and radiation (chemoradiation) for the treatment of advanced cervical cancer. Pembrolizumab, a type of immunotherapy called a checkpoint inhibitor, will be administered after or during chemoradiation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Immunologic Markers Following Combination of Study Drug With Chemoradiation |
31.31; 140.33 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities |
0; 4 | — |
| SECONDARY Metabolic Response Rate on PET/CT Imaging |
2; 7 | — |
| SECONDARY Incidence of Distant Metastases |
6; 6 | — |
| SECONDARY Progression Free Survival |
41; 38 | — |
| SECONDARY Overall Survival |
42; 41 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed cervical cancer.
- Must have adequate organ function.
Exclusion Criteria
- Subject is pregnant.
- Recurrent cervical cancer.
- Distant metastases.
- Malignancy within the last 5 years; basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy is permissable.
- Subject has had prior radiation, chemotherapy, targeted therapy, or investigational therapy for cervical cancer.
- Subject has a immunodeficiency.
- Known history of HIV, Hepatitis B, Hepatitis C, TB, or inflammatory bowel disease.
- Hypersensitivity to pembrolizumab or similar drugs.
- Subject has an active autoimmune disease in the past 2 years.
- Known history of non-infectious pneumonitis.
- Subject has an active infection.
- Subject has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases are permissible. Talk to Study Contact for specifics.
Data sourced from ClinicalTrials.gov (NCT02635360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.