Safety Study of BMS-986015 (Anti-KIR) in Combination With Ipilimumab in Subjects With Selected Advanced Tumor

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: CANCER, NOS

Treatments: Drug: Ipilimumab; Drug: Lirilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01750580

CA223-002

Details and patient eligibility

About

To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and identify the maximally tolerated dose (MTD) of BMS-986015 given in combination with ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Histologic confirmation of one of the following solid tumors that is advanced (unresectable or metastatic) for dose escalation or cohort expansion:Non-Small Cell Lung Cancer (NSCLC), Castrate Resistant Prostate Cancer (CRPC), Melanoma (MEL)
• At least one measurable lesion at baseline by Computed tomography (CT) or Magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• Biopsies: Subjects in the melanoma cohort must have at least 1 tumor site that can be biopsied at acceptable clinical risk
• Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
• Estimated life expectancy of ≥ 12 weeks
• White blood cell (WBC) ≥2000/μL, Neutrophils ≥1500/μL, Platelets ≥ 100x1000/μL, Hemoglobin ≥ 8.5 g/dL, creatinine ≤ 1.5 X upper limit of normal (ULN) mL/min, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3x ULN
• Normal thyroid function or be on stable hormone supplementation

Exclusion Criteria:

• Participation in any prior clinical study with BMS-936558 or ipilimumab that has overall survival listed as a primary/co-primary endpoint
• Subjects with known or suspected brain metastasis
• Subjects with active autoimmune disease, uncontrolled or significant cardiovascular disease
• Prior therapy with anti- Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) antibody or anti- Killer cell immunoglobulin-like receptor (KIR) antibody
• Grade 2 neuropathy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

Arm 1: Lirilumab + Ipilimumab

Experimental group

Description:

Lirilumab and Ipilimumab on specific days

Treatment:

Drug: Lirilumab

Drug: Ipilimumab