A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT03212469
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Preliminary steps : Safety Runs Safety run of the dual combination Durvalumab as single agent at the selected dose of 1500mg, every 4 weeks (Q4W) from C1D1 up to 13 doses Safety run of the triple combination: Durvalumab at 1500mg every 4 weeks (Q4W) from C1D1 up to 13 doses, Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses
  • Tremelimumab — DRUG
    Preliminary steps : Safety Runs Safety run of the triple combination: Tremelimumab at 75mg/Q4W for up to 4 doses Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses
  • SBRT — RADIATION
    Preliminary steps : Safety Runs Safety run of the dual combination: SBRT at C1D15. Safety run of the triple combination: SBRT at C1D15. Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses

Study Details

The study is an open label, multicentric, Phase I/II trial aiming to evaluate the safety, the clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.

Key Dates

Start date
Jun 20, 2017
Status verified
May 2025
Primary completion
Feb 24, 2025
Completion
Feb 24, 2025

Study Design

Enrollment
54 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with head and neck squamous cell carcinoma
  • Experimental: Patients lung cancer
  • Experimental: Patients with oesophagus cancer

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: Approximately 8 weeks ]

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