Immunotherapy and SBRT for Metastatic Head and Neck Carcinomas

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Study ID
NCT03283605
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • SBRT — RADIATION
    SBRT to 2-5 oligometastases will be administered between Cycle 2 and 3 of durvalumab and tremelimumab. All SBRT will be completed within a 3-week period.
  • Durvalumab — DRUG
    Durvalumab (1500 mg IV q4weeks) for 4 cycles in combination with tremelimumab. Then, durvalumab alone until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria met.
  • Tremelimumab — DRUG
    Tremelimumab (75mg IV q4weeks) for 4 cycles in combination with Durvalumab.

Study Details

Immunotherapy targeting the PD-1/PD-L1 pathway had previously been shown to be efficacious in the treatment of patients with metastatic head and neck squamous cell carcinomas. Stereotactic Body Radiotherapy (SBRT) to metastatic lesions causes localized cancer cell killing and the release of cancer cell debris, which could stimulate the immune system in the presence of immunotherapy. The purpose of this study is to assess the tolerability and efficacy of combining Durvalumab (MEDI4736), Tremelimumab and SBRT in controlling cancer progression. SBRT will be administered to patients while they are receiving Durvalumab and Tremelimumab.

Key Dates

Start date
Jul 17, 2018
Status verified
Jun 2024
Primary completion
Jul 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + tremelimumab and SBRT
    All subjects will receive durvalumab (1500 mg IV q4week) and tremelimumab (75mg q4week) for 4 doses, followed by durvalumab alone (1500 mg IV q4week) until disease progression, unacceptable toxicity or patient withdrawal. SBRT will be administered between cycle 2 and 3 of durvalumab and tremelimumab. All SBRT will be completed within a 3-week period.

Primary Outcome Measure

Acute toxicities of the treatment [ Time Frame: 3 months ]

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