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

Phase 3

Completed

• Conditions: disseminated melanoma; Stage 3; stage 4 melanoma; 10040900

• Registration Number: NL-OMON31643
• Lead Sponsor: Vical Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the overall response rate at *24 weeks after randomization in the<br /><br>Allovectin-7® arm versus the control (DTIC/TMZ) arm.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>First, to investigate the effect of Allovectin-7® in comparison to DTIC/ TMZ on<br /><br>overall survival. Second: To investigate the safety/tolerability of<br /><br>Allovectin-7® in comparison to DTIC/TMZ.</p><br>