Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Aggressive Pituitary Tumors
1 other identifier
interventional
9
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2019
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2019
CompletedStudy Start
First participant enrolled
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
August 8, 2025
August 1, 2025
6.9 years
July 31, 2019
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic response rate
Radiographic response rate will be assessed by RANO/iRANO
36 weeks from baseline
Secondary Outcomes (1)
Safety as assessed by CTCAE 5.0
36 weeks from baseline
Study Arms (1)
Pituitary Cancer
EXPERIMENTALParticipants will have a pituitary adenoma/carcinoma of any histology
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Neutrophils \>/= 1500/uL
- Platelets \>/= 100 x 10\^3/uL
- Hemoglobin \> 9.0 g/dL
- AST/ALT \</=3 x ULN
- Total Bilirubin \</= 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \<3.0 mg/dL)
- +5 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10021, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Publications (1)
Dai C, Liang S, Sun B, Kang J. The Progress of Immunotherapy in Refractory Pituitary Adenomas and Pituitary Carcinomas. Front Endocrinol (Lausanne). 2020 Dec 11;11:608422. doi: 10.3389/fendo.2020.608422. eCollection 2020.
PMID: 33362722DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Lin, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2019
First Posted
August 2, 2019
Study Start
July 31, 2019
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.