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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

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.Check my eligibility
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.See study design
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
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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic response rate
Secondary outcome measures
Safety as assessed by CTCAE 5.0

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Hypothyroidism
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Dry mouth
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Cardiac failure
2%
Malignant pleural effusion
2%
Sepsis
2%
Atrial fibrillation
2%
General physical health deterioration
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Cancer pain
1%
Confusional state
1%
Circulatory collapse
1%
Bronchial obstruction
1%
Pneumothorax
1%
Atrial flutter
1%
Ileus
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion
1%
Femur fracture
1%
Pancytopenia
1%
Colitis
1%
Small intestinal obstruction
1%
Hypercalcaemia
1%
Syncope
1%
Pericardial effusion malignant
1%
Superior vena cava syndrome
1%
Gastrointestinal haemorrhage
1%
Lung cancer metastatic
1%
Performance status decreased
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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
2014
Completed Phase 3
~4740
Ipilimumab
2014
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,742 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
~2 spots leftby Jul 2025
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