A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma

Part of paid clinical trials in Houston, Texas.

Sponsor
Enterome
Study ID
NCT04187404
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Adrenocortical Carcinoma
  • Paraganglioma
  • Pheochromocytoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EO2401 — BIOLOGICAL
    Multiple dose of EO2401
  • Nivolumab — BIOLOGICAL
    Multiple dose of nivolumab

Study Details

This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.

Key Dates

Start date
Jul 23, 2020
Status verified
Jan 2026
Primary completion
Oct 2, 2024
Completion
Oct 2, 2024

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5-cohort study design
    Cohort 1:3-by-3 design of EO2401 in combination with nivolumab at standard dose. Three to 12 evaluable patients with adrenal carcinoma or progressive malignant pheochromocytoma/paraganglioma will be included depending on the safety profile of the administered treatments. Cohorts 2A (previously treated patients) and 2B (previously untreated patients): evaluation of EO2401in combination with nivolumab in 33 patients with adrenal carcinoma. Cohorts 3A (previously treated patients) and 3B (previously untreated patients) : evaluation of EO2401 combination with nivolumab in 20 patients (globally for both Cohorts 3A and 3B) with progressive malignant pheochromocytoma/ paraganglioma.
  • Experimental: randomized extension of Cohort 2A (3 arms): C2A-I
    Randomized extension of Cohort 2A (65 patients using a 4:1:1 ratio): 43 patients belonging to this extension of Cohort 2A will be treated by EO2401 and nivolumab in combination.
  • Experimental: randomized extension of Cohort 2A (3 arms): C2A-II
    11 patients belonging to this extension of Cohort 2A will be treated by EO2401 alone.
  • Active Comparator: randomized extension of Cohort 2A (3 arms): C2A-III
    11 patients belonging to this extension of Cohort 2A who will be treated by nivolumab alone.

Primary Outcome Measure

Treatment-Emergent Serious Adverse Events Assessment [ Time Frame: 46 months maximum (from baseline up to study end) ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

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MD Anderson Cancer Center· Houston, TX

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