Nivolumab + Ipilimumab for Pituitary Cancer

Recruiting at 11 trial locations

Overseen By Andrew Lin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

9 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have stopped taking temozolomide at least 4 weeks before joining. If you're on corticosteroids, you can only take up to 4mg of dexamethasone per day, unless it's a replacement dose for adrenal insufficiency.

What data supports the effectiveness of the drug combination Nivolumab and Ipilimumab for pituitary cancer?

Some early reports suggest that the combination of Nivolumab and Ipilimumab, which are immune-checkpoint inhibitors, has been successfully used in patients with certain types of pituitary cancer, particularly those secreting ACTH. These drugs have shown promise in other cancers by helping the immune system attack cancer cells, and tumors with certain characteristics might respond better to this treatment. ^{1 2 3 4 5}

Is the combination of Nivolumab and Ipilimumab generally safe for humans?

The combination of Nivolumab and Ipilimumab can cause immune-related side effects, including hypophysitis (inflammation of the pituitary gland), which may lead to hormonal imbalances. These side effects can be serious and require prompt treatment, but they are known and monitored during therapy. ^{1 6 7 8 9}

How is the drug combination of Nivolumab and Ipilimumab unique for treating pituitary cancer?

Nivolumab and Ipilimumab are immune-checkpoint inhibitors, a type of drug that helps the immune system recognize and attack cancer cells. This combination is unique for pituitary cancer because there are no standard treatments once other therapies fail, and these drugs offer a new hope by targeting the immune system, which may be more effective for certain types of pituitary tumors. ^{1 4 5 10 11}

Research Team

Andrew Lin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Women of childbearing potential must have a negative pregnancy test when they join the study.

I have a tumor in my pituitary gland.

Your blood test results must meet certain standards.

Exclusion Criteria

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

You have had a strong allergic reaction to any monoclonal antibody in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab and ipilimumab for aggressive pituitary tumors

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nivolumab and Ipilimumab

Trial Overview 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.

Participant Groups

Group I: Pituitary Cancer Experimental Treatment 2 Interventions

Participants will have a pituitary adenoma/carcinoma of any histology

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Ipilimumab, a monoclonal antibody used to treat melanoma, enhances T-cell activation and has been linked to improved overall survival, but it can also cause immune-related adverse events like skin rash, diarrhea, and colitis.

This report highlights a rare case of a patient developing both uveitis and hypophysitis after ipilimumab treatment, demonstrating that these immune-related side effects can occur weeks after the last dose and may present diagnostic challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ipilimumab-induced hypophysitis and uveitis in a patient with metastatic melanoma and a history of ipilimumab-induced skin rash. Nallapaneni, NN., Mourya, R., Bhatt, VR., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Immune-checkpoint inhibitors in pituitary malignancies. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Expression of programmed death-ligand 1 (PD-L1) in human pituitary neuroendocrine tumor. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Increased expression of programmed death ligand 1 (PD-L1) in human pituitary tumors. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Immunotherapy in aggressive pituitary tumors and carcinomas: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Immune profiling of pituitary tumors reveals variations in immune infiltration and checkpoint molecule expression. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Ipilimumab-induced hypophysitis and uveitis in a patient with metastatic melanoma and a history of ipilimumab-induced skin rash. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Immune Checkpoint Inhibitor-Induced Hypophysitis and Patterns of Loss of Pituitary Function. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pituitary-Related Adverse Events and Onset Patterns Caused by Immune Checkpoint Inhibitors: Analysis Using the Japanese Adverse Drug Event Report Database. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Hypophysitis induced by ipilimumab and nivolumab combination therapy for advanced renal cell carcinoma: A case report. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Immunotherapy in Corticotroph and Lactotroph Aggressive Tumors and Carcinomas: Two Case Reports and a Review of the Literature. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Hypophysitis secondary to nivolumab and pembrolizumab is a clinical entity distinct from ipilimumab-associated hypophysitis. [2022]