Clinical Trial: Checkpoint Inhibitors Assessment in Oropharynx Carcinoma (CIAO)

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

Official Title: Checkpoint Inhibitors Assessment in Oropharynx Carcinoma (CIAO)

Brief Summary:

The goal of this clinical research study is to learn if giving durvalumab alone or in combination with tremelimumab to patients with oropharynx carcinoma before standard-of-care surgery can help to control the disease.

The safety of these drugs will also be studied.


Detailed Summary:

Study Groups:

If participant is found to be eligible to take part in this study, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study cohorts. This is done because no one knows if one cohort is better, the same, or worse than the other.

  • If participant is in Cohort 1, participant will receive durvalumab.
  • If participant is in Cohort 2, participant will receive durvalumab and tremelimumab.

Both participant and the study doctor will know to which group participant has been assigned.

Study Drug Administration:

Participant will receive durvalumab by vein over 1 hour every 4 weeks. If participant is in Cohort 2, participant will also receive tremelimumab by vein over 1 hour every 4 weeks.

After participant's first dose of study drug(s), participant will be observed for 1 hour to watch for any side effects.

Length of Study Participation:

Participant may receive the study drug(s) for up to 2 doses. Participant will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Participation on the study will be over after the follow-up visits.

Study Visits:

On Day 1:

  • Blood (about 2 teaspoons) will be drawn for bi
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Change of CD8+ Tumor Infiltrating Lymphocytes of Durvalumab Single Agent or Combined with Tremelimumab [ Time Frame: Baseline and 6 months after surgery ]

    Primary endpoint is the change of CD8+ tumor infiltrating lymphocytes before and after treatment, defined as the ratio of the CD8+ lymphocytes density in the post-treatment surgical specimens over the CD8+ density in the baseline biopsy before treatment.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Adverse Events of Durvalumab Single Agent or Combined with Tremelimumab [ Time Frame: 8 weeks ]
      Adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
    • Objective Response Rate (ORR) of Durvalumab Single Agent or Combined with Tremelimumab [ Time Frame: 8 weeks ]
      Objective response rate (ORR) assessed by RECIST 1.1.


    Original Secondary Outcome: Same as current

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: May 5, 2017
    Date Started: August 2017
    Date Completion: August 2020
    Last Updated: May 5, 2017
    Last Verified: May 2017