Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Melanoma

Treatments: Drug: AntiCD137; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803374

CA186-007

Details and patient eligibility

About

The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed malignant melanoma
• Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
• Willing to undergo up to 3 biopsies of an accessible lesion

Exclusion criteria

• Active/symptomatic brain metastases
• Primary ocular melanoma or primary tumor of unknown origin
• Concurrent autoimmune disease
• Previous treatment with a CD137 agonist or CTLA-4 inhibitor

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 5 patient groups

0.1 mg/kg

Experimental group

Treatment:

Drug: AntiCD137

Drug: Ipilimumab

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

0.3 mg/kg

Experimental group

Treatment:

Drug: AntiCD137

Drug: Ipilimumab

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

1.0 mg/kg

Experimental group

Treatment:

Drug: AntiCD137

Drug: Ipilimumab

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

3.0 mg/kg

Experimental group

Treatment:

Drug: AntiCD137

Drug: Ipilimumab

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

10 mg/kg

Experimental group

Treatment:

Drug: AntiCD137

Drug: Ipilimumab

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137

Drug: AntiCD137