Table 1.
Clinical trials that are actively recruiting for adrenocortical carcinoma.
| Clinical trial | Phase | Intervention(s) | Location | Design | Primary endpoint(s) |
|---|---|---|---|---|---|
| Cabazitaxel Activity in Patients With Advanced Adrenocortical-Carcinoma Progressing After Previous Chemotherapy Lines (CabACC) | II | Cabazitaxel | Azienda Ospedaliera Spedali Civili di Brescia (Brescia, Italy) | Prospective, non-randomized, multicenter, open label, single arm, phase II study in patients with advanced ACC | To assess clinical benefit after 4 months of cabazitaxel in patients with locally advanced or metastatic ACC who progressed after cytotoxic therapy |
| Cabozantinib in Advanced Adrenocortical Carcinoma (CaboACC) | II | Cabozantinib-s-malate | University Hospital Würzburg (Würzburg, Germany) | Prospective, non-randomized, open-label, single arm, single center phase II in patients with locally advanced or metastatic ACC refractory to standard treatment | Progression-free survival at 4 months |
| Adjuvant Chemotherapy vs. Observation/Mitotane After Primary Surgical Resection of Localized Adrenocortical Carcinoma (ACACIA) | III | Cisplatin plus Etoposide vs Observation or Mitotane | ASST Spedali Civili di Brescia (Brescia, Italy) | Prospective, randomized, open-label, stratified, nation-based multicenter, phase II trial for patients with Ki67≥ 10% after resection with curative intent | Comparison of recurrence-free survival in patients treated with adjuvant chemotherapy ± mitotane vs no treatment or adjuvant mitotane |
| A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma (Spencer) | I/II | Biological: EO2401 | MD Anderson Cancer Center (Houston, TX, USA), 8 other sites | Multicenter, phase I/II, first-in-human study to assess safety, tolerability, immunogenicity, and efficacy of EO2401 in metastatic ACC | Adverse events assessment |
| Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma | II | Cisplatin, Sodium thiosulfate, Cytoreductive surgery |
Columbia University Medical Center (New York, NY, USA) | Prospective, non-randomized, open-label phase II trial in patients with ACC that undergo successful debulking will then undergo HIPEC | Progression-free survival |
| Cabozantinib in Treating Patients With Locally Advanced or Metastatic Unresectable Adrenocortical Carcinoma | II | Cabozantinib | MD Anderson Cancer Center (Houston, TX, USA) | Prospective, non-randomized, open-label, single arm, single center phase II in patients with locally advanced or metastatic ACC refractory to standard treatment | Progression-free survival at 4 months |
| Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Participants With Stage I-III Adrenocortical Cancer With High Risk of Recurrence (ADIUVO-2) | III | Cisplatin, Etoposide, Mitotane | MD Anderson Cancer Center (Houston, TX, USA) | Prospective, randomized, open-label, parallel assignment in patients with stage I-III ACC with high risk of recurrence | Compare effect of adjuvant mitotane alone with adjuvant mitotane + etoposide/cisplatin on recurrence-free survival in high-risk ACC after initial resection |
| Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors | II | Nivolumab, Ipilimumab | Dana-Farber Cancer Institute (Boston, MA, USA), 5 other sites | Prospective, non-randomized, multicenter, open label, single arm, phase II study in patients with advanced rare genitourinary tumors | Objective response rate |
| Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors | II | Cabozantinib-S-malate | National Cancer Institute (Bethesda, MD), 143 other sites | Prospective, non-randomized, multicenter, open label, single arm, phase II study in children and young adults with refractory sarcomas, Wilms Tumor, and other rare tumors | Objective response rate in children and young adults |
| Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed By Surgery or Are Metastatic | II | Pembrolizumab | MD Anderson Cancer Center (Houston, TX, USA) | Prospective, non-randomized, single center, open label, single arm, phase II study in patients with rare tumors | Non-progression rate Incidence of adverse events |
| Nivolumab and Ipilimumab in Treating Patients With Rare Tumors | II | Nivolumab, Ipilimumab | National Cancer Institute (Bethesda, MD), 939 other sites | Prospective, non-randomized, multicenter, open label, single arm, phase II study in patients with rare tumors | Objective overall response rates |