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NCT04703426
Sargramostim (GM-CSF) + PD-1
Phase 2 trial testing Sargramostim (GM-CSF) in Unresectable Melanoma. Withdrawn.
10 June 2024
Quick facts
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 16 April 2021 |
| Primary completion | 10 June 2024 |
| Estimated completion | 9 June 2025 |
Drugs / interventions tested
- Sargramostim (GM-CSF) — full drug profile →
- Pembrolizumab (anti-PD-1) — full drug profile →
Conditions studied
- Unresectable Melanoma — all drugs for Unresectable Melanoma →
- Metastatic Melanoma — all drugs for Metastatic Melanoma →
- Stage III Melanoma — all drugs for Stage III Melanoma →
- Stage IV Melanoma — all drugs for Stage IV Melanoma →
Sponsor
Dana-Farber Cancer Institute
Who can join
18 and older, any sex, with Unresectable Melanoma or Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This research study is testing the combination of two drugs, sargramostim and pembrolizumab. The study is designed to see if the combination of these study drugs would improve the control of unresectable or metastatic melanoma cancer when compared to use of these drugs alone. The names of the study drugs involved in this study are: * Pembrolizumab * Sargramostim (GM-CSF)
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Harnessing the tumor microenvironment: targeted cancer therapies through modulation of epithelial-mesenchymal transition.
Glaviano A, Lau HS, Carter LM, Lee EHC, et al · · 2025 · cited 90× · PMID 39806516 · DOI 10.1186/s13045-024-01634-6 -
Potential therapies for immune-related adverse events associated with immune checkpoint inhibition: from monoclonal antibodies to kinase inhibition.
Henderson Berg MH, Del Rincón SV, Miller WH. · · 2022 · cited 36× · PMID 35086945 · DOI 10.1136/jitc-2021-003551 -
Recombinant GM-CSF for diseases of GM-CSF insufficiency: Correcting dysfunctional mononuclear phagocyte disorders.
Lazarus HM, Pitts K, Wang T, Lee E, et al · · 2022 · cited 16× · PMID 36685591 · DOI 10.3389/fimmu.2022.1069444 -
Shaping the Future of Immunotherapy Targets and Biomarkers in Melanoma and Non-Melanoma Cutaneous Cancers.
Spiliopoulou P, Vornicova O, Genta S, Spreafico A. · · 2023 · cited 10× · PMID 36674809 · DOI 10.3390/ijms24021294
Verify or expand the search:
- PubMed search for NCT04703426
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Unresectable Melanoma
Currently open trials in the same condition.
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- NCT05896839 — Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metasta · Phase 1, PHASE2 · recruiting
- NCT05727904 — Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untrea · Phase 3 · recruiting
- NCT04616248 — In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metasta · Phase 1 · active not recruiting
- NCT05136196 — BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or S · Phase 2 · recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
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- NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO) · NA · not yet recruiting
- NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults · NA · not yet recruiting
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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 NCT04703426 (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 Dana-Farber Cancer Institute
- Last refreshed: 22 May 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/NCT04703426.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing