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Clinical Trials/NL-OMON31643
NL-OMON31643
Completed
Phase 3

A Phase 3 Clinical Trial to evaluate the safety and efficacy of treatment with 2 mg intralesional Allovectin-7® compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in subjects with recurrent metastatic melanoma - Allovectin-7® immunotherapy for metastatic melanoma (A.I.M.M.)

Vical Incorporated0 sites15 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Vical Incorporated
Enrollment
15
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Vical Incorporated

Eligibility Criteria

Inclusion Criteria

  • •\* Histologically confirmed recurrent metastatic melanoma, which may have received primary surgical resection, adjuvant therapy, and/or biotherapy
  • •\* At least one injectable lesion (cutaneous, subcutaneous, or nodal lesion) \*1 cm2 and \* 25 cm2
  • •\* Normal LDH
  • •\* ECOG performance status of 0 or 1

Exclusion Criteria

  • •\* Surgery is deemed a curative option
  • •\* Prior cytotoxic chemotherapy
  • •\* Any lesion \*100 cm2
  • •\* History of visceral metastasis, M1c, other than lung (M1b not excluded)

Outcomes

Primary Outcomes

Not specified

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