Nivolumab + Ipilimumab for Salivary Gland Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two drugs, nivolumab and ipilimumab, to assess their effects on people with salivary gland cancer. It seeks to understand both the positive and negative impacts of these treatments on the condition. The trial consists of two parts: one for individuals with adenoid cystic carcinoma (a type of salivary gland cancer) and another for other types of salivary gland cancer. Individuals with recurring or spreading salivary gland cancer that cannot be cured with surgery or radiation might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you can continue hormonal therapies like drugs targeting the androgen receptor. You must wait at least 2 weeks after finishing other systemic treatments before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of nivolumab and ipilimumab has been tested in patients with salivary gland cancers. One study found that about 38% of patients experienced significant side effects from the treatment. Although these side effects were serious, many patients could still continue with the treatment.
The treatments have demonstrated moderate success in controlling the disease, helping manage the cancer without significant progression in some patients. Both drugs assist the immune system in attacking cancer cells. These findings suggest that while there are risks of side effects, many patients have managed them, and the treatments might help control the cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using nivolumab and ipilimumab for salivary gland cancer because these drugs represent a fresh approach by harnessing the power of the immune system. Unlike traditional treatments like surgery, radiation, or chemotherapy, which directly target cancer cells, these drugs are immunotherapies. They work by helping the immune system recognize and attack cancer cells more effectively. Nivolumab and ipilimumab specifically target and block certain proteins that prevent immune cells from killing cancer cells, potentially leading to more effective and long-lasting responses. This mechanism offers hope for patients, especially those with recurrent or metastatic forms of salivary gland cancer, where current options are limited.
What evidence suggests that this trial's treatments could be effective for salivary gland cancer?
Research shows that using nivolumab and ipilimumab together can help control disease in patients with recurring or spreading salivary gland cancers. In this trial, participants with adenoid cystic carcinoma (ACC) will receive this combination. Some studies found these drugs are not very effective for ACC, with rare, exceptional cases where they worked well. Participants with other types of salivary gland cancers will also receive nivolumab and ipilimumab, and this treatment might be more promising for these types. These drugs help the immune system find and attack cancer cells. While not a guaranteed cure, early results suggest they could be beneficial, especially for certain types of salivary gland cancers.12345
Who Is on the Research Team?
Alan L Ho, MD, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Adults with confirmed salivary gland cancer, except adenoid cystic carcinoma, can join this trial. They must have measurable disease and be in good physical condition (able to perform daily activities or only limited help needed). Participants need proper organ function, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and have no recent high-dose steroids or immune diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab and Ipilimumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania