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NCT03132675: Keynote-695
Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment
Phase 2 trial testing tavokinogene telseplasmid in Stage III/IV Melanoma in 143 participants. Status unknown.
31 March 2023
Quick facts
| Lead sponsor | OncoSec Medical Incorporated |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 143 |
| Start date | 3 October 2017 |
| Primary completion | 31 March 2023 |
| Estimated completion | 31 July 2024 |
| Sites | 33 locations across Italy, Canada, Switzerland, Australia, United States |
Drugs / interventions tested
- tavokinogene telseplasmid — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
- ImmunoPulse
Conditions studied
- Stage III/IV Melanoma — all drugs for Stage III/IV Melanoma →
Sponsor
OncoSec Medical Incorporated — full company profile →
Who can join
18 and older, any sex, with Stage III/IV Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Keynote 695 is Phase 2 study of intratumoral tavokinogene telseplasmid (tavo; pIL-12) Electroporation (EP) plus IV Pembrolizumab. Eligible patients will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on either pembrolizumab or nivolumab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cytokines in clinical cancer immunotherapy.
Berraondo P, Sanmamed MF, Ochoa MC, Etxeberria I, et al · · 2019 · cited 834× · PMID 30413827 · DOI 10.1038/s41416-018-0328-y -
Interleukins in cancer: from biology to therapy.
Briukhovetska D, Dörr J, Endres S, Libby P, et al · · 2021 · cited 587× · PMID 34083781 · DOI 10.1038/s41568-021-00363-z -
IL-12 Family Cytokines in Cancer and Immunotherapy.
Mirlekar B, Pylayeva-Gupta Y. · · 2021 · cited 212× · PMID 33418929 · DOI 10.3390/cancers13020167 -
Harnessing natural killer cells for cancer immunotherapy: dispatching the first responders.
Maskalenko NA, Zhigarev D, Campbell KS. · · 2022 · cited 174× · PMID 35314852 · DOI 10.1038/s41573-022-00413-7 -
Single-cell analyses identify circulating anti-tumor CD8 T cells and markers for their enrichment.
Pauken KE, Shahid O, Lagattuta KA, Mahuron KM, et al · · 2021 · cited 109× · PMID 33651880 · DOI 10.1084/jem.20200920 -
Intratumoral Delivery of Plasmid IL12 Via Electroporation Leads to Regression of Injected and Noninjected Tumors in Merkel Cell Carcinoma.
Bhatia S, Longino NV, Miller NJ, Kulikauskas R, et al · · 2020 · cited 64× · PMID 31582519 · DOI 10.1158/1078-0432.ccr-19-0972 -
Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z -
Characterization of abscopal effects of intratumoral electroporation-mediated IL-12 gene therapy.
Mukhopadhyay A, Wright J, Shirley S, Canton DA, et al · · 2019 · cited 41× · PMID 30323352 · DOI 10.1038/s41434-018-0044-5
Verify or expand the search:
- PubMed search for NCT03132675
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other OncoSec Medical Incorporated trials
Trials by the same sponsor.
- NCT02345330 — Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC) · Phase 2 · terminated
- NCT01579318 — Phase II Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma · Phase 2 · terminated
- NCT01502293 — Trial of pIL-12 Electroporation Malignant Melanoma · Phase 2 · completed
- NCT01440816 — IL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer · Phase 2 · 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 NCT03132675 (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 OncoSec Medical Incorporated
- Last refreshed: 27 March 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/NCT03132675.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing