NCT05297565 - A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection | Crick

Overview

The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

14

Conditions

Melanoma

Interventions

Nivolumab/rHuPH20BIOLOGICAL

Specified dose on specified days

NivolumabBIOLOGICAL

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins * Complete resection performed within 12 weeks prior to randomization or treatment assignment * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Exclusion Criteria: * History of uveal or mucosal melanoma * Untreated/unresected CNS metastases or leptomeningeal metastases * Active, known or suspected autoimmune disease * Serious or uncontrolled medical disorder 4 weeks prior to screening * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible * Prior immunotherapy treatments for any prior malignancies are not permitted Other protocol-defined inclusion/exclusion criteria apply

Locations (16)

Local Institution - 0004

Fort Wayne, Indiana, United States

Local Institution - 0044

Knoxville, Tennessee, United States

Local Institution - 0038

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)

Number of Participants With Serious Adverse Events

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization.

Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)

Number of Participants With Treatment Related Adverse Events

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.

Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)

Number of Participants With Treatment Related Serious Adverse Events

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization.