Nivolumab + Ipilimumab for Pituitary Cancer

Not currently recruiting at 11 trial locations

Overseen By Andrew Lin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Corticosteroids, CTLA-4 antibodies

Disqualifiers: Autoimmune disease, Hepatitis, HIV, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two medicines, nivolumab and ipilimumab, to determine their effectiveness in treating pituitary cancer that has not improved with surgery and radiation. The research aims to find better treatments for individuals whose pituitary tumors have worsened despite standard therapies. Patients with pituitary tumors that continue to grow after radiotherapy might be suitable candidates for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that nivolumab and ipilimumab are likely to be safe for humans?

Research has shown that nivolumab and ipilimumab can help treat certain tumors. These drugs are a type of immunotherapy, which helps the body's immune system fight cancer cells.

In past studies, patients with aggressive pituitary tumors responded well to these drugs. Specifically, one study found that a tumor shrank significantly after treatment with nivolumab and ipilimumab, suggesting that using both drugs together can be effective against tumors.

Regarding safety, these treatments have been tested in different types of cancer and are generally well-tolerated by many patients. However, some people might experience side effects like tiredness, skin rash, or stomach issues. Serious side effects are less common but can occur.

Since this trial is in Phase 2, some information about safety exists, but researchers are still assessing how safe the treatment is for more people. Participants in the trial will be closely monitored to manage any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pituitary cancer?

Researchers are excited about Nivolumab and Ipilimumab for pituitary cancer because these treatments offer a novel approach compared to standard options like surgery, radiation, or dopamine agonists. Unlike these conventional treatments, Nivolumab and Ipilimumab are immune checkpoint inhibitors that work by targeting specific proteins (PD-1 and CTLA-4) to enhance the body's immune response against cancer cells. This mechanism aims to unleash the immune system to recognize and attack the tumor more effectively, offering hope for improved outcomes in cases where traditional treatments have limited success. Additionally, the potential for these drugs to work on various histologies of pituitary adenomas and carcinomas makes them particularly promising.

What evidence suggests that nivolumab and ipilimumab might be an effective treatment for pituitary cancer?

Research has shown that the drugs nivolumab and ipilimumab, which participants in this trial will receive, may help treat aggressive pituitary tumors. One study demonstrated a significant reduction in tumor size, with a 92% decrease in cancer spread to the liver after treatment. These drugs, known as immune checkpoint inhibitors, enhance the immune system's ability to find and attack cancer cells. They have been particularly successful in treating pituitary cancers that have worsened after surgery and radiation. This suggests that these treatments could be a viable option for pituitary cancer unresponsive to other treatments. ^{2 3 6 7 8}

Who Is on the Research Team?

Andrew Lin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6456994/

Marked Response of a Hypermutated ACTH-Secreting ... Following treatment with ipilimumab and nivolumab, the tumor volume of the dominant liver metastasis reduced by 92%, and the recurrent intracranial disease ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-05418

Immunotherapy (Nivolumab and Ipilimumab) for the ... This phase II trial studies how well nivolumab and ipilimumab work in treating pituitary tumors that form, grow, or spread quickly (aggressive).

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2020.608422/full

The Progress of Immunotherapy in Refractory Pituitary ... One of them is the phase II clinical trial of nivolumab combined with ipilimumab for patients with aggressive pituitary tumors (NCT04042753).

4. withpower.com withpower.com/trial/phase-3-pituitary-neoplasms-6-2019-3f775

Nivolumab + Ipilimumab for Pituitary Cancer 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521690X22000999

Immunotherapy in pituitary carcinomas and aggressive ... ICIs are far more effective in PCs than in APTs. For PCs, especially for corticotroph carcinomas, ICIs appear as a reasonable second-line therapeutic option ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02834013

Nivolumab and Ipilimumab in Treating Patients With Rare ... This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ...

7. academic.oup.com academic.oup.com/jcem/article/108/7/1585/7059946

Aggressive Pituitary Tumors and Pituitary Carcinomas ... outcome in 27 patients with aggressive pituitary tumor ... Marked response of a hypermutated ACTH-secreting pituitary carcinoma to ipilimumab and nivolumab.

8. clinicaltrial.be clinicaltrial.be/en/details/62217?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Nivolumab and Ipilimumab in People With Aggressive Pituit... The purpose of this study is to determine if nivolumab and ipilimumab are effective treatment for people with pituitary tumors have gotten worse ...