Summary
Alpelisib 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registered trials linking Alpelisib to Cervical Cancer: 3 are currently recruiting; 4 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT06145308). The largest enrolment is 880 participants (NCT05768139). Registration activity spans 2014 to 2025. No published literature item is linked to Alpelisib and Cervical Cancer in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
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 | 42.5 (trials 22.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 3 recruiting, 0 active / not yet recruiting, 4 completed, 1 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | BRAF |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT06145308 | Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing 2023 | recruiting | Phase 2 | 39 |
| NCT03601507 | Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer 2019 | terminated | Phase 2 | 9 |
| NCT02537223 | Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer 2015 | completed | Phase 1 | 9 |
| NCT02282371 | Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC) 2014 | completed | Phase 1 | 16 |
| NCT04997902 | Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) 2021 | completed | PHASE1, PHASE2 | 45 |
| NCT03138070 | A Window of Opportunity Study to Assess the Modulation of Biomarkers in Head and Neck Squamous Cell Cancer (HNSCC) By Preoperative Treatment With BYL719 2017 | completed | Not applicable | 15 |
| NCT05768139 | First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors 2023 | recruiting | PHASE1, PHASE2 | 880 |
| NCT06993844 | Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors 2025 | recruiting | PHASE1, PHASE2 | 233 |
Published literature
No publication is linked to this pair yet.
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 BRAF. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Alpelisib approved for Cervical Cancer?
Alpelisib 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 Alpelisib in clinical trials for Cervical Cancer?
ClinicalTrials.gov lists 8 registered trials linking Alpelisib to Cervical Cancer: 3 are currently recruiting; 4 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT06145308). The largest enrolment is 880 participants (NCT05768139). Registration activity spans 2014 to 2025.
What does the evidence show for Alpelisib in Cervical Cancer?
Alpelisib has 4 completed registered trials for Cervical Cancer but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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 BRAF. 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.