Last reviewed · How we verify
NCT02387125
Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Phase 1 trial testing CMB305 in Sarcoma in 79 participants. Terminated before completion.
29 March 2019
Quick facts
| Lead sponsor | Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 79 |
| Start date | 28 February 2015 |
| Primary completion | 29 March 2019 |
| Estimated completion | 29 March 2019 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- CMB305 — full drug profile →
- G100 — full drug profile →
- Metronomic CPA — full drug profile →
Conditions studied
- Sarcoma — all drugs for Sarcoma →
- Melanoma — all drugs for Melanoma →
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →
Who can join
Adults 18 to 80, any sex, with Sarcoma or Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 \[a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene\] and G305 \[NY-ESO-1 recombinant protein plus GLA-SE\]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances in ovarian cancer therapy.
Cortez AJ, Tudrej P, Kujawa KA, Lisowska KM. · · 2018 · cited 417× · PMID 29249039 · DOI 10.1007/s00280-017-3501-8 -
NY-ESO-1 Based Immunotherapy of Cancer: Current Perspectives.
Thomas R, Al-Khadairi G, Roelands J, Hendrickx W, et al · · 2018 · cited 298× · PMID 29770138 · DOI 10.3389/fimmu.2018.00947 -
Recent clinical trends in Toll-like receptor targeting therapeutics.
Anwar MA, Shah M, Kim J, Choi S. · · 2019 · cited 209× · PMID 30450666 · DOI 10.1002/med.21553 -
Viral vector-based gene therapies in the clinic.
Zhao Z, Anselmo AC, Mitragotri S. · · 2022 · cited 171× · PMID 35079633 · DOI 10.1002/btm2.10258 -
Trial Watch: Toll-like receptor agonists in cancer immunotherapy.
Smith M, García-Martínez E, Pitter MR, Fucikova J, et al · · 2018 · cited 171× · PMID 30524908 · DOI 10.1080/2162402x.2018.1526250 -
Harnessing innate immune pathways for therapeutic advancement in cancer.
Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9 -
Cancer immunotherapy beyond immune checkpoint inhibitors.
Marin-Acevedo JA, Soyano AE, Dholaria B, Knutson KL, et al · · 2018 · cited 140× · PMID 29329556 · DOI 10.1186/s13045-017-0552-6 -
Trial Watch: Immunostimulation with Toll-like receptor agonists in cancer therapy.
Iribarren K, Bloy N, Buqué A, Cremer I, et al · · 2016 · cited 98× · PMID 27141345 · DOI 10.1080/2162402x.2015.1088631
Verify or expand the search:
- PubMed search for NCT02387125
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CMB305
Trials testing the same drug.
- NCT02609984 — Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma · Phase 2 · terminated
Other recruiting trials for Sarcoma
Currently open trials in the same condition.
- NCT07402577 — Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot · recruiting
- NCT07501026 — Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC) · Phase 2 · recruiting
- NCT07359911 — Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patient · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma · Phase 1 · recruiting
Other Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials
Trials by the same sponsor.
- NCT03520959 — A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metasta · Phase 3 · terminated
- NCT02501473 — Study of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Participants With Follicular Non-Hodgkin's Lymp · Phase 1, PHASE2 · terminated
- NCT02609984 — Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma · Phase 2 · terminated
- NCT02122861 — Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1 · Phase 1 · completed
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 NCT02387125 (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 Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Last refreshed: 1 July 2020
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/NCT02387125.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing