Table 2.
Studies registered on Clinicaltrial.gov assessing ICIs for treatment of cancers in PLWHIV. Search was performed on 24 April 2021. (NSCLC: Non-small-cell lung carcinoma; cART: combination antiretroviral therapy; AEs: adverse events.).
| RCT | Study Title | Phase | Cancer | ICI | Primary Objective/s |
|---|---|---|---|---|---|
| NCT03354936 | ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint) | Observational | Any | Any | To evaluate clinical and biological safety of the use of immune checkpoint inhibitors in HIV infected patients with cancer treated by ICIs |
| NCT04514484 | Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients WITH Advanced Cancer and HIV | 1 | Advanced solid tumors | Nivolumab | To determine the safety of combined nivolumab and cabozantinib s-malate (XL184) in PLWHIV with advanced solid tumors To determine the feasibility to deliver the combined nivolumab and XL184 for a minimum of 4 cycles in at least 75% of the subjects or to achieve a confirmed objective response |
| NCT03304093 | Immunotherapy by Nivolumab for HIV+ Patients (CHIVA2) | 2 | NSCLC Metastatic NSCLC Stage IIIB |
Nivolumab | Disease control rate at 8 weeks |
| NCT02408861 | Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery | 1 | Advanced Malignant Solid Neoplasm Anal Carcinoma Kaposi Sarcoma Lung Carcinoma Metastatic Malignant Solid Neoplasm Recurrent Classic Hodgkin Lymphoma Refractory Classic Hodgkin Lymphoma Unresectable Solid Neoplasm |
Nivolumab Ipilimumab | Maximum tolerated dose of nivolumab |
| NCT03316274 | Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma | 1 | Kaposi Sarcoma | Intra-lesional injection of nivolumab | Number of dose limiting toxicity (6 months) Maximum tolerated dose (6 months) |
| NCT02595866 | Pembrolizumab in Treating Patients With HIV and Relapsed, Refractory, or Disseminated Malignant Neoplasms | 1 | Relapsed, Refractory, or Disseminated Malignant Neoplasms | Pembrolizumab | Frequency of observed adverse events Incidence of immune-related events of clinical interest Incidence of cART-related ECIs of grade 2 or higher AEs |
| NCT03094286 | Durvalumab in Solid Tumors | 2 | Solid tumors | Durvalumab | Number of HIV patients that receive durvalumab at least during 4 months |
| NCT04499053 | Durvalumab in Combination With Chemotherapy in Virus-infected Patients With Non-small Cell Lung Cancer | 2 | NSCLC Stage IV | Durvalumab | Adverse events Radiological response |