FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel

Sponsor
Centre Leon Berard
Study ID
NCT03723967
Phase
PHASE2
Status
Completed

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

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

Interventions

  • Durvalumab with Carboplatin/Paclitaxel — DRUG
    Durvalumab associated with Carboplatin / Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy

Study Details

The primary objective of the phase II trial is to determine the efficacy and safety of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy.

Key Dates

Start date
May 16, 2019
Status verified
Sep 2022
Primary completion
May 16, 2020
Completion
Mar 9, 2024

Study Design

Enrollment
104 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab with Carboplatin/Paclitaxel
    Combination of Durvalumab with Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy

Primary Outcome Measure

Evaluation of efficacy and safety of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy [ Time Frame: 12 months after study treatment initiation ]

Related Studies