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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04042753
Other study ID # 19-216
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 31, 2019
Est. completion date July 2024

Study information

Verified date June 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 9
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - 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 childbearing 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 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

Study Design


Intervention

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

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Cedars-Sinai Medical Center Los Angeles California
United States Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic response rate Radiographic response rate will be assessed by RANO/iRANO 36 weeks from baseline
Secondary Safety as assessed by CTCAE 5.0 Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 will be used to assess safety 36 weeks from baseline
See also
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Recruiting NCT03309319 - A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas N/A
Terminated NCT04106531 - Validation of a Quality of Life Metric "Prolac-10"
Recruiting NCT03719781 - Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery
Recruiting NCT01556230 - Prospective Study of Clinically Nonfunctioning Pituitary Adenomas
Recruiting NCT03132259 - Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach Phase 4
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Withdrawn NCT04863339 - Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery Phase 2
Terminated NCT00646308 - Assessment of Cardiovascular Risk Markers in Growth Hormone Deficient Patients With Nonsecreting Pituitary Adenomas N/A
Recruiting NCT00852501 - Characterization of Receptors in Non-functioning Pituitary Macroadenomas Phase 4
Completed NCT03465423 - Comparison of Propofol Requirement Between Patients With Pituitary Somatotroph Tumor and With Nonfunctioning Pituitary Tumor in Transsphenoidal Pituitary Surgery Under Total Intravenous Anesthesia
Recruiting NCT03474601 - Seoul National University Pituitary Disease Cohort Study
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Active, not recruiting NCT03636568 - Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery) N/A
Completed NCT02813044 - Effects of Total Intravenous Anesthesia With Propofol-remifentanil Versus Inhalational Anesthesia With Sevoflurane on Quality of Recovery in Patients Undergoing Transsphenoidal Surgery for Pituitary Tumor N/A
Recruiting NCT03973450 - Epidemiology of Pituitary Tumours: Prevalence of Associated Neoplasia
Recruiting NCT04018963 - The Impact of Endoscopic Pituitary Surgery on Nasal Function
Not yet recruiting NCT04938401 - Construction and Application of a Risk Prediction Model Forepistaxis After Pituitary Tumor Resection