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NCT03132675: Keynote-695

Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment

Status unknown Phase 2 Last updated 27 March 2023
What this trial tests

Phase 2 trial testing tavokinogene telseplasmid in Stage III/IV Melanoma in 143 participants. Status unknown.

Timeline
3 October 2017
Primary endpoint
31 March 2023
31 July 2024

Quick facts

Lead sponsorOncoSec Medical Incorporated
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment143
Start date3 October 2017
Primary completion31 March 2023
Estimated completion31 July 2024
Sites33 locations across Italy, Canada, Switzerland, Australia, United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. IL-12 Family Cytokines in Cancer and Immunotherapy.
    Mirlekar B, Pylayeva-Gupta Y. · · 2021 · cited 212× · PMID 33418929 · DOI 10.3390/cancers13020167
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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

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