Who is sponsoring NCT05539365?

NCT05539365 is sponsored by Roswell Park Cancer Institute.

What drugs are being tested in NCT05539365?

Interventions in NCT05539365: Alpha-type-1 Polarized Dendritic Cells, Biopsy, Computed Tomography, Leukapheresis, Pembrolizumab, Quality-of-Life Assessment.

What condition does NCT05539365 study?

NCT05539365 studies Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma.

Is NCT05539365 still recruiting?

NCT05539365 is currently withdrawn. Last updated 29 January 2025.

Last reviewed 2025-01-29 · How we verify

NCT05539365

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer

Withdrawn Phase 2 Last updated 29 January 2025

What this trial tests

Phase 2 trial testing Alpha-type-1 Polarized Dendritic Cells in Anatomic Stage III Breast Cancer AJCC v8. Withdrawn.

Timeline

1 February 2025

Primary endpoint
1 February 2027

1 February 2027

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 February 2025
Primary completion	1 February 2027
Estimated completion	1 February 2027
Sites	1 location across United States

Drugs / interventions tested

Alpha-type-1 Polarized Dendritic Cells — full drug profile →
Biopsy — full drug profile →
Computed Tomography
Leukapheresis — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →
Quality-of-Life Assessment

Conditions studied

Anatomic Stage III Breast Cancer AJCC v8 — all drugs for Anatomic Stage III Breast Cancer AJCC v8 →
Anatomic Stage IV Breast Cancer AJCC v8 — all drugs for Anatomic Stage IV Breast Cancer AJCC v8 →
Metastatic Triple-Negative Breast Carcinoma — all drugs for Metastatic Triple-Negative Breast Carcinoma →
Unresectable Triple-Negative Breast Carcinoma — all drugs for Unresectable Triple-Negative Breast Carcinoma →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, any sex, with Anatomic Stage III Breast Cancer AJCC v8 or Anatomic Stage IV Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial tests the safety, side effects, and whether dendritic cell-based treatment and pembrolizumab work in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). The term triple-negative breast cancer refers to the fact that the cancer cells don't have estrogen or progesterone receptors (ER or PR) and also don't make any or too much of the protein called HER2 (the cells test "negative" on all 3 tests). Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. Pembrolizumab, is an immune checkpoint inhibitor drug, that works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Giving dendritic cell-based therapy and pembrolizumab may decrease symptoms and improve quality of life in patients with triple negative breast cancer.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Trial watch: anticancer vaccination with dendritic cells.
Borges F, Laureano RS, Vanmeerbeek I, Sprooten J, et al · · 2024 · cited 18× · PMID 39398476 · DOI 10.1080/2162402x.2024.2412876
Improving efficacy of TNBC immunotherapy: based on analysis and subtyping of immune microenvironment.
Yang Y, Li H, Yang W, Shi Y. · · 2024 · cited 11× · PMID 39430759 · DOI 10.3389/fimmu.2024.1441667
Contracting triple-negative breast cancer with immunotherapeutic armamentarium: recent advances and clinical prospects.
Khadela A, Soni S, Megha K, Shah AC, et al · · 2022 · cited 6× · PMID 36520261 · DOI 10.1007/s12032-022-01922-6
Targeting the pericyte antigen DLK1 with an alpha type-1 polarized dendritic cell vaccine results in tumor vascular modulation and protection against colon cancer progression.
McCormick AL, Anderson TS, Daugherity EA, Okpalanwaka IF, et al · · 2023 · cited 5× · PMID 37849752 · DOI 10.3389/fimmu.2023.1241949
Application of dendritic cell extracellular vesicles as a valid nanoparticle platform for cancer therapies: a narrative review.
Nezamdoust FV, Nezhad-Mokhtari P, Mirzaahmadi B, Mazloumi Z, et al · · 2026 · PMID 42010708 · DOI 10.1186/s13287-026-05011-7

Verify or expand the search:

Other trials of Alpha-type-1 Polarized Dendritic Cells

Trials testing the same drug.

NCT04093323 — Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HL · Phase 2 · terminated
NCT03735589 — Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage · Phase 1, PHASE2 · withdrawn

Other recruiting trials for Anatomic Stage III Breast Cancer AJCC v8

Currently open trials in the same condition.

NCT07137416 — Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for H · Phase 1 · recruiting
NCT07443943 — A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive · Phase 2 · recruiting
NCT06434064 — Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advan · Phase 2 · recruiting
NCT07158021 — Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial · Phase 2 · recruiting
NCT06324240 — Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Canc · Phase 1 · recruiting

Other Roswell Park Cancer Institute trials

Trials by the same sponsor.

NCT07489287 — GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer · Phase 1 · not yet recruiting
NCT06943664 — Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-I · Phase 2 · not yet recruiting
NCT06827054 — Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids · Phase 2 · not yet recruiting
NCT06334016 — Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream · EARLY_PHASE1 · not yet recruiting
NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05539365 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Roswell Park Cancer Institute
Last refreshed: 29 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05539365.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing