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Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma

Study acronym: SPARTANA
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 22, 2023 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Nov 1, 2023 to Jun 1, 2025
    • Study completion date: Nov 1, 2025 to Nov 1, 2026
    • Site details revised at 3 of 5 sites
    v5
  2. Start date: Dec 13, 2021 to Jun 9, 2022
    • Enrollment target: 47 to 34
    • Study sites: 3 to 5
    • Eligibility criteria expanded, about 156 words
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2021 to Dec 13, 2021
    • Site details revised at 3 of 3 sites
    v3
  4. Start date: Sep 1, 2021 to Nov 1, 2021
    • Study sites: 2 to 3
    • Primary completion date: Sep 1, 2023 to Nov 1, 2023
    • Study completion date: Sep 1, 2025 to Nov 1, 2025
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study evaluates the feasibility of the combination of radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and spartalizumab (anti-PD-1 therapy) in patients with metastatic squamous cell anal carcinoma
Trial Details
NCT Number NCT04894370
Lead Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators: National Cancer Institute, France, Novartis
Conditions
(from sponsor)		 Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
Related terms Anus Neoplasms, Carcinoma, Squamous Cell
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov