Immunotherapy combo shows promise for tough pituitary tumors
NCT ID NCT04042753
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested two immunotherapy drugs, nivolumab and ipilimumab, in 10 patients with aggressive pituitary tumors that worsened after surgery and radiation. The goal was to see if the combination could shrink tumors or slow their growth. Researchers also monitored side effects closely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab and ipilimumab (immunotherapy drugs)
- What this could lead to
- If it works, this could offer a new treatment option for people with aggressive pituitary tumors that have not responded to standard therapies.
- What could go wrong
- This is a very small early-phase trial with only 10 participants, so results may not apply to everyone. Immunotherapy can cause serious side effects like inflammation of organs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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10 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10021, United States
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Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
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