Clinical Trial: Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Trial of Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

Brief Summary:

This research study is studying immunotherapy with or without radiation therapy as a possible treatment for adenoid cystic carcinoma.

The immunotherapy involved in this study is:

  • Pembrolizumab (MK-3475 or KEYTRUDA).

Detailed Summary:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational agent to learn whether it works in treating a specific disease. "Investigational" means that the drug is being studied.

Pembrolizumab (MK-3475 or KEYTRUDA) is a humanized monoclonal antibody. An antibody is a common type of protein made in the body in response to a foreign substance (particles not typically found in your body such as bacteria or viruses). Antibodies attack foreign substances and protect against infection. Antibodies can also be produced in the laboratory for use in treating patients. Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells.

The FDA recently granted approval to pembrolizumab as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma. Pembrolizumab has not been approved for treatment against adenoid cystic carcinoma.

This study is testing whether pembrolizumab with or without radiation is useful for patients with adenoid cystic carcinoma. Radiation therapy may be used to treat some ACC tumors that have spread to other parts of the body or recurred after surgery. Radiation therapy may affect the immune system to improve the efficacy of pembrolizumab


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Objective Response In Non-Irradiated Lesions (Tumor size on scans) [ Time Frame: 2 years ]

Objective response will be assessed in non-irradiated lesions among all eligible and treated patients pursuing RECIST 1.1. Objective response rate along with 90% two-stage confidence intervals will be reported in each arm.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival (Time from randomization to disease progression or death) [ Time Frame: 2 years ]
    Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Patients who are alive without disease progression will be censored at the date of last disease assessment. Progression-free survival will be evaluated using both RECIST 1.1 and immune-related response criteria (irRC), and both sets of results will be reported in each arm.
  • Overall Survival (Time from randomization to death) [ Time Frame: 2 years ]
    Overall survival is defined as the time from randomization to death or date last known alive. Overall survival will be evaluated using both RECIST 1.1 and immune-related response criteria (irRC), and both sets of results will be reported in each arm. will be evaluated using both RECIST 1.1 and immune-related response criteria (irRC), and both sets of results will be reported in each arm.
  • Duration of response (Time from onset of response to disease progression) [ Time Frame: 2 years ]
    Duration of response will be analyzed among patients with objective response and is defined as the time from onset of objective response (complete response or partial response) to documentation of disease progression.
  • Complete Response (Absence of non-irradiated lesions on scans) [ Time Frame: 2 years ]
    Complete disappearance of all measurable non-irradiated lesions. All lymph nodes must be non-pathological in size (<10 mm short axis).
  • Partial Response (Tumor size on scans) [ Time Frame: 2 years ]
    At least a 30% decrease in the longest diameter valuated using RECIST 1.1.
  • Treatment-Emergent Adverse Events [ Time Frame: 2 years ]
    All patients who receive treatment, regardless of eligibility, will be evaluable for toxicity. Toxicity will be graded according to NCI CTCAE, Version 4.0. The proportions of patients with various toxicities will be reported by treatment arm.


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: March 13, 2017
Date Started: April 25, 2017
Date Completion: October 31, 2024
Last Updated: May 19, 2017
Last Verified: May 2017