Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma (CheckMate 066)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Biological: BMS-936558 (Nivolumab); Drug: Placebo matching Dacarbazine; Biological: Placebo matching BMS-936558 (Nivolumab); Drug: Dacarbazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01721772

2012-003718-16 (EudraCT Number)

CA209-066

Details and patient eligibility

About

The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

Enrollment: 418 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:

• Men and women ≥18 years of age
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
• Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
• Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
• Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize

Exclusion Criteria:

• Active brain metastases or leptomeningeal metastases
• Ocular melanoma
• Any active, known, or suspected autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

418 participants in 2 patient groups

Nivolumab, 3 mg/kg

Experimental group

Description:

Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

Treatment:

Biological: BMS-936558 (Nivolumab)

Drug: Placebo matching Dacarbazine

Dacarbazine, 1000 mg/m^2

Active Comparator group

Description:

Participants received dacarbazine, 1000 mg/m\^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

Treatment:

Drug: Dacarbazine

Biological: Placebo matching BMS-936558 (Nivolumab)