Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06557889 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas

Study acronym: REDUCE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 6 months later Sep 2030 → Apr 2033
See other at-risk trials from Institut Claudius Regaud

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2030 to Apr 2033
    • Enrollment closed, study ongoing
    • Study sites: 14 to 13
    v11
  2. Study sites: 13 to 14v10
  3. Study sites: 8 to 13
    • Eligibility criteria expanded, about 48 words
    v9
  4. Study sites: 7 to 8v8
  5. Site details revised at 1 of 7 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 2 of 7 sitesv6
  2. Site details revised at 3 of 7 sitesv5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Oct 21, 2024
    • Site details revised at 7 of 7 sites
    v4
  4. Start date: Sep 2024 to Oct 2024v3
  5. Interventions: Once the patient is included in the study, he will receive the treatment schema as defined below: (Drug) to Pembrolizumab + Cisplatin/Carboplatin + 5-FU (Drug)
    • Eligibility criteria expanded, about 3 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and 5-Fluorouracil) in combination with pembrolizumab for the first-line treatment of CPS PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. A total of 86 patients will have to be enrolled in this study.
Trial Details
NCT Number NCT06557889
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)		 Squamous Cell Carcinoma of Head and Neck
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov