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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks from baseline
Awards & highlights

Study 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
Select...
I have a tumor in my pituitary gland.
Select...
I am 18 years old or older.
Select...
I am a man who will use contraception during and after the study, unless I am sterile or cannot produce sperm.
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...
My tumor can't be removed surgically and is likely a pituitary adenoma, as per scans or tests.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I have a pituitary carcinoma and radiotherapy is not considered beneficial for me.

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%
Pyrexia
21%
Neutropenia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
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%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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
~4750
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,611 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what capacity is Nivolumab typically utilized?

"Nivolumab is a common remedy for conditions that have not responded to anti-angiogenic therapy. It has also been used successfully to address malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

To what extent is this medical research project being implemented in various hospitals across the state?

"8 facilities are presently enrolling individuals for this trial, situated in Uniondale, Middletown and Commack alongside other nearby locations. Therefore, it is recommended to select a site closest to you in order to reduce your need of travelling if participating."

Answered by AI

Have researchers previously investigated the efficacy of Nivolumab?

"Currently, Nivolumab is the subject of 765 active clinical studies with 86 in their last stage. While Pittsburgh, Pennsylvania serves as a hub for these trials, 42755 medical sites are conducting research on this medication worldwide."

Answered by AI

What is the current magnitude of subjects receiving treatment in this experiment?

"21 individuals who meet the prerequisites of this trial need to be recruited. Potential participants can join from Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale, New york and Memoral Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, New jersey."

Answered by AI

To what extent can Nivolumab be detrimental to patient health?

"The safety of Nivolumab is rated as a 2, since the Phase 2 trial has presented evidence in favour of its security but not its efficacy."

Answered by AI

Are there any open vacancies for this clinical trial?

"According to clinicaltrials.gov, this research endeavour is actively seeking the participation of patients; it was initially posted on July 31st 2019 and amended in October 2021."

Answered by AI
~0 spots leftby Jul 2024