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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Pituitary Cancer

Phase 2
Waitlist Available
Led By Andrew Lin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A pituitary adenoma/carcinoma of any histology
Age greater than or equal to 18
Must not have
Inability to undergo radiographic surveillance
Women who are pregnant or breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks from baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if nivolumab and ipilimumab can help people with pituitary tumors that have worsened after surgery and radiation.

Who is the study for?
Adults with aggressive pituitary tumors that have worsened after surgery and radiation can join this trial. They must not need high doses of steroids, have no severe autoimmune diseases or infections like HIV/HBV/HCV, and women must avoid pregnancy.
What is being tested?
The study is testing the effectiveness of two drugs, Nivolumab and Ipilimumab, in treating pituitary tumors that are unresponsive to traditional treatments like surgery and radiation.
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid), digestive issues, fatigue, respiratory conditions, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a tumor in my pituitary gland.
Select...
I am 18 years old or older.
Select...
My cancer has grown after radiation treatment.
Select...
It's been over 4 weeks since my last temozolomide dose and I've recovered from other chemotherapy effects.
Select...
I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot have imaging tests for monitoring my condition.
Select...
I am not pregnant or breast-feeding.
Select...
I do not have a history of hepatitis B or C infection.
Select...
I take more than 4mg of dexamethasone daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic response rate
Secondary study objectives
Safety as assessed by CTCAE 5.0

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pituitary CancerExperimental Treatment2 Interventions
Participants will have a pituitary adenoma/carcinoma of any histology
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3070

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,403 Total Patients Enrolled
Andrew Lin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Nivolumab and Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04042753 — Phase 2
Pituitary Tumors Research Study Groups: Pituitary Cancer
Pituitary Tumors Clinical Trial 2023: Nivolumab and Ipilimumab Highlights & Side Effects. Trial Name: NCT04042753 — Phase 2
Nivolumab and Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04042753 — Phase 2
~1 spots leftby Jul 2025
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