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Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors

Primary Purpose

Pituitary, Pituitary Tumor, Pituitary Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ipilimumab
Nivolumab
Nivolumab
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary focused on measuring Pituitary tumor, Nivolumab, Ipilimumab, 19-216

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  • Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pituitary Cancer

Arm Description

Participants will have a pituitary adenoma/carcinoma of any histology

Outcomes

Primary Outcome Measures

Radiographic response rate
Radiographic response rate will be assessed by RANO/iRANO

Secondary Outcome Measures

Safety as assessed by CTCAE 5.0
Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 will be used to assess safety

Full Information

First Posted
July 31, 2019
Last Updated
June 29, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04042753
Brief Title
Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors
Official Title
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Aggressive Pituitary Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary, Pituitary Tumor, Pituitary Carcinoma, Pituitary Cancer
Keywords
Pituitary tumor, Nivolumab, Ipilimumab, 19-216

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pituitary Cancer
Arm Type
Experimental
Arm Description
Participants will have a pituitary adenoma/carcinoma of any histology
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
Ipilimumab 3 mg/kg every 3 weeks,
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab 1 mg/kg every 3 weeks for 4 cycles
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Single agent Nivolumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Radiographic response rate
Description
Radiographic response rate will be assessed by RANO/iRANO
Time Frame
36 weeks from baseline
Secondary Outcome Measure Information:
Title
Safety as assessed by CTCAE 5.0
Description
Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 will be used to assess safety
Time Frame
36 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Lin, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33362722
Citation
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.
Results Reference
derived
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors

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