Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05529316 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment target: 174 to 150
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints: 8 to 4
    v11
  2. Enrollment target: estimated 220 to confirmed 174
    • Study sites: 49 to 51
    • Primary and study completion dates: May 2028 to Feb 2028
    v10
  3. Trial status: Suspended to Active, Not Recruitingv9
  4. Trial status: Recruiting to Suspended Sponsor's reason: As a business decision, this study has been paused. There are no safety concerns.
    • Primary and study completion dates: Oct 2023 to May 2028
    • Study sites: 50 to 49
    v8
  5. Study sites: 44 to 50v7
Show 5 earlier versionsHide 5 earlier versions
  1. Enrollment target: 200 to 220v6 Show 6 more changesShow less
    • Interventions: Botensilimab (Drug) to Balstilimab (Drug), Botensilimab (Drug)
    • Eligibility criteria expanded, about 148 words
    • Secondary endpoints: 6 to 8
    • Study description expanded, about 52 words
    • Site contacts updated at 3 of 44 sites
    • Study arms: 3 to 4
  2. Study sites: 45 to 44v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 44 to 45
    • Start date changed from estimate of Nov 2022 to Dec 12, 2022
    v4
  4. Start date: Oct 2022 to Nov 2022v3
  5. Enrollment target: 120 to 200v2 Show 4 more changesShow less
    • Eligibility criteria expanded, about 32 words
    • Study description revised
    • Study sites revised (44)
    • Study arms: 4 to 3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Agenus Inc.
6 trials monitored
See all monitored trials
Melanoma
1,092 trials monitored
See 60 trials at risk
This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.
Trial Details
NCT Number NCT05529316
Lead Sponsor Agenus Inc.
Conditions
(from sponsor)		 Advanced Melanoma
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov