Clinical trial · Interventional
Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer
A Randomized Phase II Study of Chemoradiation and Pembrolizumab for Locally Advanced Cancer
NCT02635360CI-TRIAL-00091735completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Following chemoradiation
- description
- Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
- interventionNames
- Drug: Pembrolizumab
- Radiation: Brachytherapy
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Concurrent to chemoradiation
- description
- Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
- interventionNames
- Drug: Pembrolizumab
- Radiation: Brachytherapy
- Drug: Cisplatin
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLin AJ, Dehdashti F, Massad LS, Thaker PH, Powell MA, Mutch DG, Schwarz JK, Markovina S, Siegel BA, Grigsby PW. Long-Term Outcomes of Cervical Cancer Patients Treated With Definitive Chemoradiation Following a Complete Metabolic Response. Clin Oncol (R Coll Radiol). 2021 May;33(5):300-306. doi: 10.1016/j.clon.2021.01.010. Epub 2021 Feb 11. PMID 33581976