Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Aggressive Pituitary Tumors

Memorial Sloan Kettering Cancer Center8 sites in 1 country9 target enrollmentJuly 31, 2019

ConditionsPituitary Pituitary Tumor Pituitary Carcinoma Pituitary Cancer

InterventionsIpilimumab Nivolumab

Overview

Phase: Phase 2
Intervention: Ipilimumab
Conditions: Pituitary
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 9
Locations: 8
Primary Endpoint: Radiographic response rate
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if nivolumab and ipilimumab are effective treatment for people with pituitary tumors have gotten worse after surgery and radiation.

Registry

clinicaltrials.gov

Start Date

July 31, 2019

End Date

July 1, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age greater than or equal to 18
•A pituitary adenoma/carcinoma of any histology
•° Patients with unresectable tumors that are radiographically (and/or biochemically) consistent with a pituitary adenoma may be considered for enrollment without pathologic confirmation with approval from the principal investigator.
•Progression on imaging following radiotherapy
•° Patients with pituitary carcinomas in whom there is not felt to be a palliative benefit to treatment with radiotherapy are eligible for enrollment without prior radiotherapy.
•Measurable disease by RANO criteria
•At least 4 weeks have elapsed since the patient last received temozolomide and the patient must have recovered hematologically from other chemotherapeutics
•Karnofsky Performance Status (KPS) greater than or equal to 70
•Screening laboratory values must meet the following criteria:
•WBC \>/= 2000/uL

Exclusion Criteria

•A corticosteroid requirement of greater than 4mg per day of dexamethasone (or an equivalent dose). NOTE: Patients requiring a physiologic replacement dose of corticosteroids, who may require stress dose corticosteroids, due to adrenal insufficiency are permitted onto this trial
•Active, known, or suspected autoimmune disease within the past 2 years. NOTE: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
•Patients should be excluded if they have had prior systemic treatment with a CTLA-4 antibody. Prior treatment with PD1 or PD-L1 antibodies are permitted as long as the patient did not experience serious toxicities requiring treatment discontinuation related to prior PD-1 or PD-L1 therapy
•Patients should be excluded if they have a known history of testing positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV antibody) indicating acute or chronic infection
•Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
•History of allergy to study drug components
•History of severe hypersensitivity reaction to any monoclonal antibody
•Women who are pregnant or breast-feeding
•Inability to undergo radiographic surveillance