West Cancer Center

MELANOMA: Neoadjuvant; Injectable disease; "20110266"

A phase 2, multicenter, randomized, open-label trial assessing the efficacy and safety of talimogene laherparepvec neoadjuvant treatment plus surgery versus surgery alone for resectable, stage IIB to IVM1a melanoma

Title

Amgen 20110266

Study Title

Site Link

study/NCT02211131

Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 4

Disease Setting

Neoadjuvant

Line Of Therapy

N/A

Investigational Agent

Talimogene laherparepvec (T-VEC)

Drug Class

Oncolytic virus

Martin Fleming, MD

Sponsor

Amgen

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

https://clinicaltrials.gov/ct2/show/study/NCT02211131

Key Eligibility Criteria Details

-Histologically confirmed diagnosis of stage IIB, IIIC, or IVM1a melanoma elgible for complete surgical resection

- Measurable disease

- Injectable disease (cutaneous, subcutanous, or nodal lesions) measuring in aggregate > 10mm in diameter

- ECOG PS 0-1

- No ocular or mucosal melanoma

- No history of autoimmune disease

- No known HBV/HCV/HIV

Objective

Primary- Recurrence Free Survival, Secondary- R0 surgical margin; PathCR; OS; ORR; Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Cutaneous melanoma

Dosing Frequency

Control Agents

Surgery alone

Study Protocol

Randomized

Yes