Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Ocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Aldesleukin

Immunomodulating Agents

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Cycle 1:

(600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient.

Days 1-5 and Days 15-19 (all patients)

Aldesleukin: All Patients

Cycle 1: 6 Week Duration Nivolumab 240 mg IV

Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29

Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15

Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study

Nivolumab: Cohort 1 (Cutaneous)

Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29

OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:

Nivolumab 1 mg/kg IV on Day 29

Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29

Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29.

Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study

Nivolumab: Cohort 2 (Ocular)

Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29

OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:

Ipilimumab 3 mg/kg IV on Day 29

Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29

Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29

Ipilimumab: Cohort 2 (Ocular)

Evidio Domingo-Musibay, MD

This is a Phase 2 study designed to evaluate the combination of checkpoint blockade and aldesleukin (IL-2) therapy after a course of standard of care palliative radiation in the management of unresectable metastatic melanoma. To be eligible, a patient must have a minimum of 3 (preferably \>5) radiographically distinct, measurable (\>1.5 cm) lesions based on RECIST 1.1. Metastatic cutaneous melanoma must be refractory to standard immunotherapy drugs, molecular targeted agents and/or chemotherapy. Patients with ocular melanoma subtypes may enroll in this study without prior therapy, as there is no standard front-line therapy for this subset of patients.

Radiation and Combination Immunotherapy for Melanoma

A Phase 2 Study of Palliative Radiation and Combination Sequential Immunotherapy for Metastatic Cutaneous Melanoma and Ocular Melanoma

Determine the objective response rate (ORR). The ORR will be presented as the proportion of patients who achieved complete response (CR) or partial response (PR). In general, categorical data measurements will be summarized as counts and percentages (or proportions). The disease control rate (DCR) will be presented as the proportion of patients with CR, PR, or stable disease. The best overall response (BOR) will be measured as the maximum change from baseline in the sum of the longest diameter for each of the target lesions over the full 2 year follow-up period.

This will be achieved by the number of adverse event (AE) reports. AEs, SAEs, deaths, and abnormal laboratory values will be summarized by the proportion of patients who experience them. Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All on-study AEs, Grade 3-4 AEs, treatment-related AEs, Grade 3-4 treatment-related AEs, SAEs, treatment-related SAEs, and AEs leading to discontinuation will be tabulated using the worst grade per NCI CTCAE v 5.0 criteria by system organ class.

This will be measured by the number of participants who are suspended from the trial as noted by a stopping rule event. These events are determined after serious adverse events are graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The following events count toward an early stopping rule event: 1) Any Grade 2 or greater drug-related uveitis, eye pain, or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within 7 days of checkpoint inhibitor OR requires systemic treatment with corticosteroids, 2) Any Grade 3 or greater non-skin, drug-related adverse event lasting \> 7 days, including uveitis, pneumonitis, bronchospasm, diarrhea, colitis, neurologic toxicity, hypersensitivity reactions, and infusion reactions. In addition, the trial would be stopped and re-evaluated if there is ≥ 1 treatment-related mortality event.

Masonic Cancer Center, University of Minnesota

Aldesleukin: All Patients: Cycle 1:

(600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient.

Days 1-5 and Days 15-19 (all patients)

Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV

Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29

Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15

Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study

Cohort 1: Nivolumab

Aldesleukin: All Patients: Cycle 1:

(600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient.

Days 1-5 and Days 15-19 (all patients)

Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29

OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:

Nivolumab 1 mg/kg IV on Day 29

Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29

Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29.

Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study

Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29

OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:

Ipilimumab 3 mg/kg IV on Day 29

Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29

Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29

Cohort 2: Nivolumab & Ipilimumab

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Objective Response Rate (ORR)

Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Adverse Events)

Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events)

Overall Study

Spots Global Cancer Trial Database for Radiation and Combination Immunotherapy for Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial