A Phase 1/2 Trial of a Novel Therapeutic Vaccine (EO2401) in Combination With Immune Check Point Blockade, for Treatment of Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma

Who is this study for? Adult patients with Adrenocortical Carcinoma or Malignant Pheochromocytoma/Paraganglioma
What treatments are being studied? EO2401
Status: Terminated
Location: See all (12) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• For inclusion in Cohort 1 patients should have adrenocortical carcinoma(ACC), or malignant pheochromocytoma/paraganglioma (MPP), as defined below for Cohorts 2A and 3A.

• For inclusion in Cohorts 2A and 2B patients should have histologically confirmed (at primary diagnosis) unresectable locally advanced or metastatic adrenocortical carcinoma.

• For inclusion in Cohorts 3A and 3B patients should have histologically confirmed (at primary diagnosis) unresectable malignant (defined as metastatic disease, i.e. presence of chromaffin tissue in non-chromaffin organs) pheochromocytoma/paraganglioma, and RECIST defined progression should have been documented during a maximum of an 18-months period.

• Patients with an age ≥ 18 years old.

• Patients who are human leukocyte antigen (HLA)-A2 positive.

• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

• Patients with a life expectancy \> 4 months as judged by their treating physician.

• Patients with at least one measurable lesion according to RECIST 1.1.

• Males or non-pregnant, non-lactating, females.

⁃ Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

⁃ Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.

Locations
United States
Texas
MD Anderson Cancer Center
Houston
Other Locations
Denmark
Rigshospitalet
Copenhagen
France
Chu Lille
Lille
Centre Léon Bérard
Lyon
Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
Marseille
Institut Gustave Roussy
Villejuif
Germany
Lmu Klinikum
München
Universitätsklinikum Würzburg
Würzburg
Italy
Azienda Ospedaliera Spedali Civili
Brescia
Netherlands
Amsterdam UMC, location VUmc
Amsterdam
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Sweden
Karolinska University Hospital
Stockholm
Time Frame
Start Date: 2020-07-23
Completion Date: 2024-10-02
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Leads: Enterome

This content was sourced from clinicaltrials.gov