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Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors

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ClinicalTrials.gov Identifier: NCT04042753
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Pituitary Pituitary Tumor Pituitary Carcinoma Pituitary Cancer Drug: Ipilimumab Drug: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Aggressive Pituitary Tumors
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Pituitary Cancer
Participants will have a pituitary adenoma/carcinoma of any histology
Drug: Ipilimumab
Ipilimumab 3 mg/kg every 3 weeks,

Drug: Nivolumab
Nivolumab 1 mg/kg every 3 weeks for 4 cycles

Drug: Nivolumab
Following concurrent ipilimumab and nivolumab, patients will receive single agent nivolumab at 480 mg every 4 weeks for 6 cycles (1 cycle=4 weeks) with the option of continuing until disease progression or until the end of the study, whichever occurs first
Other Name: Single agent Nivolumab




Primary Outcome Measures :
  1. Radiographic response rate [ Time Frame: 36 weeks from baseline ]
    Radiographic response rate will be assessed by RANO/iRANO


Secondary Outcome Measures :
  1. Safety as assessed by CTCAE 5.0 [ Time Frame: 36 weeks from baseline ]
    Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 will be used to assess safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18
  • A pituitary adenoma/carcinoma of any histology
  • Progression on imaging following radiotherapy
  • Measurable disease by RANO criteria
  • 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)
  • Serum creatinine </= 1.5 x ULN or creatinine clearance (CrCl) >/= 40 mL/min using the Cockcroft-Gault formula
  • Women of childbearing potential (WOCBP) must use appropriate method(s) or contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug

    • WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. Women who are not of childbearing potential are not required to use contraception
    • Women of childbearing potential must have a negative serum or urine pregnancy test upon study entry
  • Men who are sexually active with women of child bearing potential must use adequate contraception upon study entry until 31 weeks after the last dose of study treatment. Men who are surgically sterile or azoospermic do not require contraception.

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
  • At least 4 weeks have elapsed since the patient last received temozolomide and the patient must have recovered hematologically from other chemotherapeutics to enroll
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042753


Contacts
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Contact: Andrew Lin, MD 212-639-8392 lina1@mskcc.org
Contact: Eliza Geer, MD 646-888-2627 geere@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrew Lin, MD    212-639-8392      
Memoral Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Andrew Lin, MD    212-639-8392      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Andrew Lin, MD    212-639-8392      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Andrew Lin, MD    212-639-8392      
Memoral Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Andrew Lin, MD    212-639-8392      
Memorial Sloan - Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10021
Contact: Andrew Lin, MD    212-639-8392      
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Andrew Lin, MD    212-639-8392      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Andrew Lin, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04042753     History of Changes
Other Study ID Numbers: 19-216
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Pituitary tumor
Nivolumab
Ipilimumab
19-216
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents