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NCT04757662
Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma
Phase 1 trial testing Tadalafil in Grade III Astrocytoma in 18 participants. Completed in 7 June 2023.
7 June 2023
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 14 May 2021 |
| Primary completion | 7 June 2023 |
| Estimated completion | 7 June 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tadalafil (tadalafil) — full drug profile →
Conditions studied
- Grade III Astrocytoma — all drugs for Grade III Astrocytoma →
- Grade IV Astrocytoma — all drugs for Grade IV Astrocytoma →
- Astrocytoma, Grade IV — all drugs for Astrocytoma, Grade IV →
- Astrocytoma, Grade III — all drugs for Astrocytoma, Grade III →
Sponsor
Washington University School of Medicine
Who can join
18 and older, any sex, with Grade III Astrocytoma or Grade IV Astrocytoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Increasing preclinical and clinical data have shown that myeloid-derived suppressor cells (MDSCs) may represent a significant driver of immunosuppression in glioblastoma (GBM, grade IV astrocytoma) and a potential mechanism of treatment resistance to chemoradiotherapy. Tadalafil, an FDA-approved drug with inexpensive cost and excellent safety profile, has been shown to effectively reduce MDSCs and restore T-cell activation in the peripheral blood and in the tumor microenvironment. The purpose of this study is to investigate the impact of targeting MDSCs in newly diagnosed IDH-wildtype grade III-IV astrocytoma by combining tadalafil with standard of care radiation therapy (RT) and temozolomide (TMZ).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Myeloid-derived suppressor cells in cancer: therapeutic targets to overcome tumor immune evasion.
Lu J, Luo Y, Rao D, Wang T, et al · · 2024 · cited 89× · PMID 38609997 · DOI 10.1186/s40164-024-00505-7 -
Radiation-induced circulating myeloid-derived suppressor cells induce systemic lymphopenia after chemoradiotherapy in patients with glioblastoma.
Ghosh S, Huang J, Inkman M, Zhang J, et al · · 2023 · cited 72× · PMID 36696484 · DOI 10.1126/scitranslmed.abn6758 -
Tumor-Treating Fields in Glioblastomas: Past, Present, and Future.
Guo X, Yang X, Wu J, Yang H, et al · · 2022 · cited 39× · PMID 35954334 · DOI 10.3390/cancers14153669 -
Therapeutic Values of Myeloid-Derived Suppressor Cells in Hepatocellular Carcinoma: Facts and Hopes.
Wang Y, Zhang T, Sun M, Ji X, et al · · 2021 · cited 26× · PMID 34680276 · DOI 10.3390/cancers13205127 -
The multifaceted mechanisms of malignant glioblastoma progression and clinical implications.
Sun R, Kim AH. · · 2022 · cited 21× · PMID 35920986 · DOI 10.1007/s10555-022-10051-5 -
Modulation of T-cell function by myeloid-derived suppressor cells in hematological malignancies.
Bhardwaj V, Ansell SM. · · 2023 · cited 20× · PMID 37091970 · DOI 10.3389/fcell.2023.1129343 -
A pilot phase Ib study to evaluate tadalafil to overcome immunosuppression during chemoradiotherapy for IDH-wild-type glioblastoma.
Ghosh S, Johanns TM, Chheda MG, Liu E, et al · · 2023 · cited 4× · PMID 37554225 · DOI 10.1093/noajnl/vdad088
Verify or expand the search:
- PubMed search for NCT04757662
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Washington University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04757662 (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 Washington University School of Medicine
- Last refreshed: 13 June 2023
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/NCT04757662.
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