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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT03146650
Phase
PHASE2
Status
Unknown

Conditions

  • Major Salivary Gland Carcinoma
  • Minor Salivary Gland Carcinoma
  • Recurrent Salivary Gland Carcinoma
  • Stage IV Major Salivary Gland Carcinoma
  • Stage IVA Major Salivary Gland Carcinoma
  • Stage IVB Major Salivary Gland Carcinoma
  • Stage IVC Major Salivary Gland Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
May 19, 2017
Status verified
Dec 2023
Primary completion
Feb 24, 2021
Completion
Aug 11, 2025

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab, ipilimumab)
    Patients receive nivolumab IV over 30 minutes on days 1, 15, 29, 43, 57, and 71 of course 1 and on days 1 and 15 of course 2, over 60 minutes on days 29 and 57 of course 2 and on days 1, 29, and 57 of subsequent courses. Patients also receive ipilimumab over 90 minutes on days 1 and 43. Courses repeat every 84 days in the absence of disease progression or unexpected toxicity.

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, IL

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