Nivolumab + Ipilimumab for Salivary Gland Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Alan L. Ho, MD, PhD - MSK Head and Neck ...

Overseen byAlan L Ho, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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.

See 23 more

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.

See 6 more

Treatment Details

Interventions

Nivolumab and Ipilimumab (Checkpoint Inhibitor)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: R/M adenoid cystic carcinoma (ACC)Experimental Treatment2 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 Treatment2 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).