Nivolumab + Ipilimumab for Salivary Gland Cancer

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Autoimmune disease, HIV, Hepatitis, 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: 2 years

64 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out what effects, good and/or bad, treatment with two drugs called nivolumab and ipilimumab have on the participant and salivary cancer.

Research Team

Alan L Ho, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

My kidney function, based on my age, weight, and creatinine levels, is suitable.

Women who are not of childbearing potential are not required to use contraception.

My cancer has worsened or spread in the last 6 months, as shown by scans or symptoms.

Exclusion Criteria

History of allergy to study drug components.

You have had a serious allergic reaction to any type of antibody medication in the past.

I haven't taken high doses of steroids or other immune-weakening medicines in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks

2 years

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 combination of two immunotherapy drugs called Nivolumab and Ipilimumab on patients with salivary gland cancer. It aims to discover the positive and negative effects these drugs may have on participants' health and their cancer.

Participant Groups

Group I: R/M adenoid cystic carcinoma (ACC) Experimental Treatment 2 Interventions

Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).

Group II: R/M SGC of any histology, except ACC (Non ACC) Experimental Treatment 2 Interventions

Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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