Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.

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Detailed Description

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Conditions

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Neoplasms by Site

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558

Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years

Group Type EXPERIMENTAL

Denenicokin

Intervention Type BIOLOGICAL

Nivolumab

Intervention Type BIOLOGICAL

Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558

Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years

Group Type EXPERIMENTAL

Denenicokin

Intervention Type BIOLOGICAL

Nivolumab

Intervention Type BIOLOGICAL

Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558

Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years

Group Type EXPERIMENTAL

Denenicokin

Intervention Type BIOLOGICAL

Nivolumab

Intervention Type BIOLOGICAL

Interventions

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Denenicokin

Intervention Type BIOLOGICAL

Nivolumab

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-982470 rIL-21(recombinant interleukin 21) BMS-936558 Anti-PD-1 (Anti-Programmed-Death-1) MDX-1106

Eligibility Criteria

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Inclusion Criteria

* All subjects will have locally advanced or metastatic solid tumors
* For Part 2 (Cohort Expansion):

* Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma
* At least 1 lesion with measurable disease
* Only subjects with tumor samples that are PD-L1 positive or negative are eligible