UnknownPhase 2

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer

United States25 participantsStarted 2017-05-19

Plain-language summary

This phase II trial studies the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combination in participants with this type of cancer. Another purpose of the study is to see which tumor markers (proteins in the blood that the body produces in response to the cancer) lead to better results in participants treated with the study drugs. Nivolumab and ipilimumab are antibodies, which are human proteins that recognize and attach to a part of the tumor and/or body's immune cells. They work in slightly different ways to activate the immune system and help the body's immune system to work against tumor cells. Nivolumab and ipilimumab are investigational because they are not approved by the FDA to be used for the type of cancer being studied.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologically or cytologically confirmed metastatic/recurrent adenoid cystic carcinoma (ACC) or non-adenoid cystic carcinomas (non-ACC) of major or minor salivary glands * Patients must have evidence of disease progression and cannot be a candidate for surgical treatment * NOTE: Disease progression is defined as one of the following occurring within the 6 months prior to study entry: * At least a 20% increase in radiologically or clinically measurable lesions * Appearance of any new lesions or * Symptomatic and/or deterioration in clinical status * Patients must have received at least one prior line of systemic therapy * NOTE: There is no limit to the number of prior therapies for stage IV disease * NOTE: Patients should not be a candidate for surgical treatment * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1 * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) status of 0-2 * NOTE: ECOG performance status 3 will be allowed only if thought to be directly secondary to adenoid cystic carcinoma disease by treating physician * Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: leukocytes \>= 2,000/mcL * Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: absol…

What they're measuring

Progression-Free Survival

Timeframe: From the start of treatment and every 12 weeks during treatment, for up to two years, where 1 cycle =12 weeks/84 days, and range of cycles attempted was 1-11.

Median Progression-free Survival

Timeframe: From the start of treatment and every 12 weeks during treatment, for up to two years, where 1 cycle =12 weeks/84 days, and range of cycles attempted was 1-11.

Trial details

NCT IDNCT03146650

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-24

Results submitted2023-12-21

View on ClinicalTrials.gov More Major Salivary Gland Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Progression-Free Survival

Timeframe: From the start of treatment and every 12 weeks during treatment, for up to two years, where 1 cycle =12 weeks/84 days, and range of cycles attempted was 1-11.

Median Progression-free Survival

Timeframe: From the start of treatment and every 12 weeks during treatment, for up to two years, where 1 cycle =12 weeks/84 days, and range of cycles attempted was 1-11.