Durvalumab With or Without Tremelimumab in Treating Participants With Stage II-IVA Oropharyngeal Squamous Cell Cancer

Conditions

• Stage II Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7
• Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  Given IV
• Tremelimumab — BIOLOGICAL
  Given IV

Study Details

This phase I trial studies how well durvalumab with or without tremelimumab works in treating participants with stage II-IVA oropharyngeal squamous cell cancer. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date

Jul 12, 2017

Status verified

Mar 2021

Primary completion

Mar 15, 2021

Completion

Mar 15, 2021

Study Design

Enrollment

39 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort I (durvalumab)
  Participants receive durvalumab IV over 1 hour on days 1 and 29 in the absence of disease progression or unaccepted toxicity. Between days 52 and 72, participants undergo standard of care surgery.
• Experimental: Cohort II (durvalumab, tremelimumab)
  Participants receive durvalumab IV over 1 hour and tremelimumab IV over 1 hour on days 1 and 29 in the absence of disease progression or unaccepted toxicity. Between days 52 and 72, participants undergo standard of care surgery.

Primary Outcome Measure

Change of CD8+ tumor infiltrating lymphocytes [ Time Frame: Before and after treatment, assessed up to 5 years ]

Locations (1)

Find similar trials in Houston, TX

Related Studies

• Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer
  PHASE2/PHASE3 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama