Clinical Trial: Nivolumab and Ipilimumab in Treating Patients With Metastatic Recurrent Major or Minor Salivary Gland Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase II Study of Nivolumab and Ipilimumab for Treatment of Advanced Adenoid Cystic Carcinoma and Non-adenoid Cystic Carcinoma

Brief 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess median progression-free survival rate (PFSR) as well as PFSR at 6 and 12 months in patients with recurrent or metastatic adenoid cystic carcinoma (ACC) treated with a combination of nivolumab and ipilimumab.

SECONDARY OBJECTIVES:

I. To assess the efficacy of nivolumab and ipilimumab according to response rate (RR), disease control rate (DCR; complete response [CR], partial response [PR], and stable disease [SD] at 6 and 12 months), overall survival (OS) and progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with recurrent or metastatic ACC.

II. To assess the efficacy of nivolumab and ipilimumab according to overall response rate (ORR), DCR, progression free survival (PFS), and OS in patients with recurrent or metastatic ACC using immune-related response criteria (irRC) criteria.

III. To assess the safety and tolerability profile of nivolumab and ipilimumab therapy in patients with recurrent or metastatic ACC using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

TERTIARY OBJECTIVES:

I. Assess safety, tolerability and activity of Nivolumab and Ipilimumab in non-ACC malignant salivary gland tumors (MSGT's) using clinical benefit rate (CBR), ORR, PFS, OS.

II. To assess the predictive value of genomic aberrations observed upon comprehensive genomic profiling of the tumor deoxyribonucleic acid (DNA) derived from archival tumor tissue, if available, or blood from patients with recurrent or metastatic ACC and non-ACC MSGTs
Sponsor: Northwestern University

Current Primary Outcome:

• Median PFS (median Progression-Free Survival) [ Time Frame: Up to 2 years ]
  Median PFS will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
• PFS at 6 months [ Time Frame: At 6 months ]
  PFS will be assessed at 6 months using RECIST 1.1 criteria.
• PFS at 12 months [ Time Frame: At 12 months ]
  PFS will be assessed at 12 months using RECIST 1.1 criteria.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Response Rate (RR) [ Time Frame: Up to 2 years ]
  RR will be evaluated by RECIST 1.1 in patients with recurrent or metastatic ACC.
• Disease Control Rate (DCR) [ Time Frame: At 6 months ]
  DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with recurrent or metastatic ACC.
• Disease Control Rate (DCR) [ Time Frame: At 12 months ]
  DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with recurrent or metastatic ACC.
• Overall Survival (OS) [ Time Frame: Up to 2 years ]
  Overall survival (OS) is defined as time in months from the date of first study treatment to the date of death and will be evaluated using RECIST 1.1 criteria.
• PFS (RECIST 1.1 criteria) [ Time Frame: Up to 2 years ]
  PFS defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first.
• Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
  ORR will be assessed by immune-related response (irRECIST) criteria in patients with recurrent or metastatic ACC.
• DCR (irRECIST) [ Time Frame: At 6 months ]
  DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by irRECIST in patients with recurrent or metastatic ACC.
• DCR (irRECIST) [ Time Frame: At 12 months ]
  DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by irRECIST in patients with recurrent or metastatic ACC.
• PFS (irRECIST criteria) [ Time Frame: Up to 2 years ]
  PFS will be evaluated using irRECIST criteria.
• OS (irRECIST) [ Time Frame: Up to 2 years ]
  OS is defined as time in months from the date of first study treatment to the date of death and will be evaluated using irRECIST criteria.
• Incidence of Adverse Events [ Time Frame: 30 days after study treatment ]
  Assess the safety and tolerability of the combination of nivolumab and ipilimumab by evaluating the number, frequency, and severity of adverse events using CTCAE version 4.03.

Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: May 5, 2017
Date Started: June 2017
Date Completion: June 2022
Last Updated: May 8, 2017
Last Verified: March 2017