Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma

Phase 3

Recruiting

Conditions: Advanced (unresectable or metastatic) melanoma
10040900

Registration Number: NL-OMON47433

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

-Adult subjects (>=18 years) with histologically confirmed unresectable Stage III or Stage IV Melanoma as per AJCC staging system.;-Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;-No prior systemic anticancer therapy for unresectable or metastatic melanoma. Prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized.;-Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) criteria;-Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. In order to be randomized, a subject must be classified as PD-L1 positive, PD-L1 negative, or PD-L1 indeterminate. If an insufficient amount of tumor tissue from an unresectable or metastatic site is available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumor tissue for performance of biomarker analyses.;-Known BRAF V600 mutation status as determined by local institutional standard or subject to consent to BRAF V600 mutation testing per local institutional standards during the Screening Period, the results of which must be reported within 3 months of randomization. All BRAF statuses (BRAF wild-type or BRAF 600 mutation positive) are eligible.

Exclusion Criteria

- Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no evidence of progression via magnetic resonance imaging (MRI, except where contraindicated in which CT scan is acceptable) for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.;-Ocular melanoma;-Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol;ADDITIONAL FOR PET TRACER SUB STUDY:
Additional exclusion criteria for PET imaging. Subjects with the following condition(s) may be considered for participation in the study but will not undergo the PD-L1 PET imaging:
- Subjects who cannot tolerate an imaging procedure.
- Subjects who have received therapeutic radiopharmaceutical within 7 days prior to participation in
this study.
- Subjects with history of IV drug use which would prevent venous access for PET tracer injection.