1126P - Phase II study of ipilimumab plus temozolomide in patients with metastatic melanoma

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anticancer agents
Skin cancers
Biological therapy
Presenter Sapna Patel
Authors S. Patel1, R. Bassett2, W. Hwu1, K. Kim1, N. Papadopoulos1, P. Hwu1, A. Bedikian1
  • 1Melanoma Medical Oncology, MD Anderson Cancer Center, 77030-4009 - Houston/US
  • 2Biostatistics, MD Anderson Cancer Center, 77030 - Houston/US



Ipilimumab (Ipi) alters the immune system balance by inhibiting the suppression of T-cell function. In two Phase III trials, Ipi has shown an overall survival benefit alone and in combination with dacarbazine in previously treated and treatment-naïve patients (pts) with metastatic melanoma (MM), respectively. We performed a single-institution, Phase II clinical trial of Ipi plus temozolomide (Tem) in pts with MM.


Pts between the ages of 18 and 75 with previously untreated unresectable Stage III or Stage IV MM and an ECOG Performance Status (PS) of 0 to 1 were enrolled in a Phase II trial of Ipi plus Tem. Induction phase consisted of Ipi 10mg/kg intravenous on Day 1 and oral Tem 200 mg/m2 on Days 1 – 4 every 3 weeks for 4 doses. Maintenance consisted of Ipi 10 mg/kg intravenous on Day 1 starting week 12 and repeated every 12 weeks and oral Tem 200 mg/m2 on Days 1 – 5 starting week 12 and repeated every 4 weeks until disease progression or unacceptable toxicity occurred. The primary endpoint was progression-free survival (PFS) rate at 6 months. Responses were evaluated using immune-related response criteria.


Sixty-four pts were enrolled and received at least one dose of study drug. All pts were included in the analysis. With a median follow-up of 51 weeks, the PFS rate at 6 months was 45%, exceeding the proposed rate of 30%, and the median PFS was 22 weeks. There were 10 (15.6%) confirmed complete responses and 10 (15.6%) confirmed partial responses. To date, median overall survival has not been reached. Among many variables including age, gender, ECOG PS, and stage, there was a statistically significant difference in PFS in the group of patients with bone metastasis and those without bone metastasis.


At a median follow-up of 51 weeks, the overall response rate in this study is 31%. Ipi at 10 mg/kg in combination with Tem given in an induction followed by maintenance fashion is safe, well-tolerated, and efficacious in MM. The primary endpoint of 6-month PFS has been reached and exceeded.

Factors Associated with PFS

No. of Pts Median PFS (weeks) Univariate P-Value Hazard Ratio 95% CI
Bone Mets
No 57 24 1.00
Yes 7 12 0.01 2.73 1.20 – 6.20


S. Patel: Research funding from Bristol-Myers Squibb.

W. Hwu: Research funding from Merck Research funding from Bristol-Myers Squibb.

K. Kim: Research funding from Bristol-Myers Squibb Advisory board, honoraria from Bristol-Myers Squibb.

All other authors have declared no conflicts of interest.