Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05855811 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

PREventing Second Cancers With DOSTARlimab

Study acronym: PREDOSTAR
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 3 wordsv7
  2. Site details revised at 1 of 5 sites
    • Eligibility criteria expanded, about 5 words
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Study sites: 1 to 5v4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jul 15, 2028 to Jul 26, 2028
    • Study completion date: Mar 15, 2029 to Mar 26, 2029
    • Start date changed from estimate of Jul 15, 2023 to Jul 26, 2023
    • Site details revised
  6. Secondary endpoints: details revised at 1 of 6 entriesv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
PredoSTAR is a multicenter, randomized, open-label phase II study proposed to patients at high risk of SPC and in whom the treatment of the FPC does not include immunotherapy. Dostarlimab treatment will be started within 6 months after the completion of treatment for localized FPC (i.e. after the end of last CT, RT cure or surgery with a wash-out period of 4 weeks before to start Dostarlimab). Eligible patients will be randomized (1:1) to receive: * Arm Dostarlimab : 4 intravenous (IV) injections of dostarlimab, Q3W or * Arm No treatment
Trial Details
NCT Number NCT05855811
Lead Sponsor Centre Leon Berard
Collaborators: GlaxoSmithKline
Conditions
(from sponsor)		 Recurrent Cancer, Primary Cancer, Second Cancer
Related terms Neoplasms, Neoplasms, Second Primary, Recurrence
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov