Summary
Cemiplimab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cervical Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cervical Cancer. ClinicalTrials.gov lists 8 registered trials linking Cemiplimab to Cervical Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 1 has completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT03669718). It plans or enrolled 194 participants. Registration activity spans 2017 to 2023. The literature layer holds 7 publications for this pair: 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2022 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Cervical Cancer ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: CIN2/3 (precancerous): spontaneous regression in 40-60% of CIN2 without treatment; CIN3: regression in ~30%; invasive cervical cancer: no spontaneous regression.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 56.0 (trials 20.0, literature 16.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 2 active / not yet recruiting, 1 completed, 4 other |
| Linked publications | 7 (5 clinical trial publications, 1 systematic review, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | CDK12 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT05878288 | Deep sequencIng in Cutaneous Squamous CEll caRciNomas 2023 | active, not recruiting | Phase 2 | 11 |
| NCT03916627 | Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients 2019 | active, not recruiting | Phase 2 | 65 |
| NCT05929664 | Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery 2023 | suspended | Phase 2 | 70 |
| NCT03669718 | A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC 2018 | status unknown | Phase 2 | 194 |
| NCT05535023 | Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma 2022 | withdrawn | Phase 2 | — |
| NCT03198130 | An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1) 2017 | completed | Phase 1 | 33 |
| NCT06052852 | Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies 2023 | terminated | Phase 1 | 17 |
| NCT04954599 | Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI 2023 | recruiting | PHASE1, PHASE2 | 126 |
Published literature
- Clinical trial publication Cemiplimab plus peltopepimut-S vaccine in recurrent cervical cancer: A phase 2 clinical trialLorusso D, Oaknin A, Borges GS et al. · Gynecologic oncology · 2025 · PMID 40154184
- Clinical trial publication Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trialOaknin A, Monk BJ, de Melo AC et al. · European journal of cancer (Oxford, England : 1990) · 2025 · PMID 39798514
- Systematic review Cost-effectiveness of chemotherapy for advanced and recurrent cervical cancer: a systematic reviewInami K · Frontiers in health services · 2025 · PMID 40792176
- Clinical trial publication Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancerHasegawa K, Takahashi S, Ushijima K et al. · Cancer medicine · 2024 · PMID 39325020
- Clinical trial publication Population pharmacokinetics modeling and exposure-response analyses of cemiplimab in patients with recurrent or metastatic cervical cancerNguyen JH, Epling D, Dolphin N et al. · CPT: pharmacometrics & systems pharmacology · 2022 · PMID 36251220
- Clinical trial publication EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancerOaknin A, Monk BJ, Vergote I et al. · European journal of cancer (Oxford, England : 1990) · 2022 · PMID 35922251
- Randomized controlled trial Survival with Cemiplimab in Recurrent Cervical CancerTewari KS, Monk BJ, Vergote I et al. · The New England journal of medicine · 2022 · PMID 35139273
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CDK12. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Cemiplimab approved for Cervical Cancer?
Cemiplimab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cervical Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cervical Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cemiplimab in clinical trials for Cervical Cancer?
ClinicalTrials.gov lists 8 registered trials linking Cemiplimab to Cervical Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 1 has completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT03669718). It plans or enrolled 194 participants. Registration activity spans 2017 to 2023.
What does the evidence show for Cemiplimab in Cervical Cancer?
Cemiplimab has both completed registered trials and synthesis-level publications linked to Cervical Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CDK12. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.