Clinical Trial 19754

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03635983

Phase: Phase III
Principal Investigator: Khushalani, Nikhil

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Overview

Study Title

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma

Summary

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Objective

To compare the objective response rate (ORR) using RECIST 1.1 of NKTR-214 combined with nivolumab and that of nivolumab monotherapy in participants with previously untreated unresectable or metastatic melanoma

Treatments

Therapies

Immunotherapy

Medications

BMS-936558 (Nivolumab); NKTR-214 (Bempegaldesleukin); Nivolumab (Opdivo)

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)

Histologically confirmed stage III (unresectable) or stage IV melanoma

Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant treatment and/or nedoadjuvant treatment for melona with approved agents.(eg, BRAF/MEK inhibitors, ipilimumab, nivolumab,pembrolizumab or interferon). Participants who have had recurrence within the 6 months of completing adjuvant and/or neoadjuvant treatment are not eligible

Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment.

Measurable disease by CT or MRI per RECIST 1.1 criteria

All participants must have tissue submitted during screening.

Exclusion Criteria

Active brain metastases or leptomeningeal metastases

Uveal melanoma

Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator, would preclude the participant from adhering to the protocol or would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results

Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

HIstory or organ transplant or tissue that requires systemic use of immune suppressive agents

Active infection requiring systemic therapy within 14 days prior to randomization.

Need for more than 2 antihypertensive medications for management of hypertension (including diuretics).

Known cardiac history

Known history of positive test for HIV or known AIDS.

History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to randomization

Other protocol defined inclusion/exclusion criteria apply

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