Sipuleucel-T

Summary

Sipuleucel-T (CHEMBL1237024) is an approved cell (ATC L03AX17); indicated across 5 conditions including neoplasm and metastatic prostate carcinoma.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Cell
• ATC class: L03AX17
• Indications: 5 conditions
• Clinical trials: 33

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1237024
Name	Sipuleucel-T
Type	Cell
Max phase	4
ATC	L03AX17

Also known as: APC-8015, APC8015, Sipuleucel-t, SIPULEUCEL-T

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
neoplasm	4	MONDO:0005070	EFO:0000616

3 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
metastatic prostate carcinoma	3	MONDO:0004956	EFO:0000196
prostate adenocarcinoma	3	MONDO:0005082	EFO:0000673
prostate carcinoma	3	MONDO:0005159	EFO:0001663

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 33.

Phase distribution

Phase	Trials
PHASE2	20
PHASE3	5
PHASE1	5
Not specified	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00005947	PHASE3	COMPLETED	Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
NCT00065442	PHASE3	COMPLETED	Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
NCT00779402	PHASE3	COMPLETED	PROvenge Treatment and Early Cancer Treatment
NCT01133704	PHASE3	COMPLETED	Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
NCT03686683	PHASE3	COMPLETED	Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
NCT05751941	PHASE2	RECRUITING	Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
NCT06100705	PHASE2	RECRUITING	Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
NCT06134232	PHASE2	RECRUITING	Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
NCT00027599	PHASE2	COMPLETED	APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
NCT00715078	PHASE2	COMPLETED	To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
NCT00901342	PHASE2	COMPLETED	Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
NCT01338012	PHASE2	TERMINATED	Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
NCT01420965	PHASE2	TERMINATED	Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
NCT01431391	PHASE2	COMPLETED	Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
NCT01477749	PHASE2	COMPLETED	Sipuleucel-T Manufacturing Demonstration Study
NCT01487863	PHASE2	COMPLETED	Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
NCT01560923	PHASE2	COMPLETED	Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
NCT01706458	PHASE2	COMPLETED	Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer
NCT01807065	PHASE2	COMPLETED	Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
NCT01818986	PHASE2	COMPLETED	Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
NCT01981122	PHASE2	COMPLETED	A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
NCT02159950	PHASE2	COMPLETED	Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
NCT02463799	PHASE2	COMPLETED	Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC
NCT02793219	PHASE2	WITHDRAWN	Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer
NCT02793765	PHASE2	WITHDRAWN	Docetaxel Followed by Provenge in Metastatic Prostate Cancer
NCT05806814	PHASE1	ACTIVE_NOT_RECRUITING	Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
NCT07219147	PHASE1	RECRUITING	177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
NCT01832870	PHASE1	COMPLETED	Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer
NCT02036918	PHASE1	COMPLETED	Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer
NCT03024216	PHASE1	COMPLETED	Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer
NCT01306890	Not specified	COMPLETED	A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
NCT01727154	Not specified	TERMINATED	Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
NCT02353715	Not specified	COMPLETED	Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).