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Targeted Therapy and Avelumab in Merkel Cell Carcinoma

Study acronym: GoTHAM
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Jul 2027 to Dec 2026 · Completion date: Jul 2027 to Dec 2027 · Site details revised at 10 of 10 sitesv15 Show 3 more changesShow less
    • Primary completion date: Jul 2027 to Dec 2026
    • Completion date: Jul 2027 to Dec 2027
    • Site details revised at 10 of 10 sites
  2. Enrollment target: 38 to 19 Primary completion date: Jul 2025 to Jul 2027 · Study sites: 7 to 10 · Eligibility criteria expanded, about 43 words · 1 morev14 Show 4 more changesShow less
    • Primary completion date: Jul 2025 to Jul 2027
    • Study sites: 7 to 10
    • Eligibility criteria expanded, about 43 words
    • Study description expanded, about 11 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jul 2023 to Jul 2025 Study sites: 6 to 7 · Completion date: Jan 2024 to Jul 2027v13 Show 2 more changesShow less
    • Study sites: 6 to 7
    • Completion date: Jan 2024 to Jul 2027
  4. Enrollment target: 65 to 38 Study description revised · Study arms: 3 to 2v12 Show 2 more changesShow less
    • Study description revised
    • Study arms: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 2 of 6 sitesv10
  2. Site details revised at 1 of 6 sitesv9
  3. Re-verified, no change to tracked fieldsv8
  4. Site details revised at 1 of 6 sitesv7
  5. Site details revised at 1 of 6 sitesv6
  6. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2020 to Oct 8, 2020 · Site details revised at 6 of 6 sitesv5 Show 2 more changesShow less
    • Start date: Sep 2020 to Oct 8, 2020
    • Site details revised at 6 of 6 sites
  7. Start date: Jul 2020 to Sep 2020 Eligibility criteria expanded, about 18 words · Site contacts updated at 5 of 6 sitesv4 Show 2 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Site contacts updated at 5 of 6 sites

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 5 to 6v3
  9. Start date: Mar 2020 to Jul 2020 Study sites: 1 to 5v2 Show 1 more changeShow less
    • Study sites: 1 to 5
  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.
10.17 GoTHAM is intended as a signal-seeking, biomarker, phase Ib/II study that will evaluate the safety and anti-tumour activities of the novel combination of avelumab with 177-Lu-DOTATATE (a type of peptide receptor radionuclide therapy; PRRT) or external beam radiation therapy (EBRT) in patients with metastatic Merkel cell carcinoma (mMCC).
Trial Details
NCT Number NCT04261855
Lead Sponsor Melanoma and Skin Cancer Trials Limited
Conditions Metastatic Merkel Cell Carcinoma
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov