Phase II Single-arm Multi-center Study of Adjuvant Ipilimumab in Combination With Nivolumab in Subjects With High-risk Ocular Melanoma

Suthee Rapisuwon6 sites in 1 country52 target enrollmentJuly 26, 2018

ConditionsMelanoma Ocular Melanoma

InterventionsNivolumab Ipilimumab

DrugsNivolumab Ipilimumab

Overview

Phase: Phase 2
Intervention: Nivolumab
Conditions: Melanoma
Sponsor: Suthee Rapisuwon
Enrollment: 52
Locations: 6
Primary Endpoint: 3 year Relapse Free Survival (RFS)
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab

Registry

clinicaltrials.gov

Start Date

July 26, 2018

End Date

June 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suthee Rapisuwon

Responsible Party

Sponsor Investigator

Principal Investigator

Suthee Rapisuwon

Sponsor-Investigator

Hoosier Cancer Research Network

Eligibility Criteria

Inclusion Criteria

•Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
•Age ≥ 18 years at the time of consent. No dosing or adverse event data are currently available on the use of ipilimumab in combination with nivolumab in patients \< 18 years of age.
•ECOG Performance Status of 0-1 within 28 days prior to registration.
•Patients must have clinically confirmed ocular melanoma diagnosed by a retinal specialist or ocular oncologist. NOTE: Patients with cutaneous melanoma, acral melanoma, mucosal melanoma, or conjunctival melanoma are ineligible.
•Patients must have ocular melanoma that is considered high-risk for recurrence as defined by one of the following criteria:
•Gene Expression Profile using 15-gene panel (Castle Bioscience) and be classified as Class 2, or
•3-year recurrent risk of more than 50% as defined by Impact Genetics, or
•Monosomy of chromosome 3 with apical tumor height \> 8mm (53).
•The primary tumor measured at least 12mm in largest basal diameter as clinically determined by the site investigator. Size is based on clinical assessment (e.g. by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy.
•Archival tumor tissue is required for subjects that have had enucleation; subjects that have had enucleation but do not have available archival tissue are not eligible for participation. Archival tissue is required if available for subjects that have not had enucleation; if not available these patients are still eligible.

Exclusion Criteria

•Patients with evidence of distant metastases (stage IV ocular melanoma) are not eligible.
•Patients with local or orbital recurrence are not eligible.
•Patients with cutaneous, mucosal, acral or conjunctival melanoma are not eligible.
•Subjects with active, known, or suspected autoimmune disease. Subjects 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 absences of an external trigger are permitted to enroll.
•Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks of study drug administration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
•Participants with previous malignancies are excluded unless a complete remission was achieved at 12 months prior to study entry and no additional therapy is required or anticipated to be required during the study period (exceptions include but are not limited to, non-melanoma skin cancers; in situ bladder cancer, in situ gastric cancer, or in situ colon cancer; in situ cervical cancer/dysplasia; or breast carcinoma in situ).
•History of Grade ≥ 3 allergy to human monoclonal antibodies.
•Subjects who have had prior immunotherapy, including but not limited to interferon alfa-2b, PEG-IFN, anti-PD-1, anti-PD-L1, anti-CTLA4 intra-tumoral or vaccine therapies are not permitted to enroll.
•Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the participant before registration in the trial.
•Subjects who are receiving any other investigational agents.