Trial results for the Phase 1 study (NCT02408861) investigating nivolumab and ipilimumab in patients with HIV-associated relapsed or refractory classical Hodgkin lymphoma or solid tumors were posted on ClinicalTrials.gov on 2025-09-23. The trial found the maximum tolerated dose of nivolumab to be 3 mg/kg in de-escalation cohorts, with a low incidence of dose-limiting toxicities.
Background
The trial, titled "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," aimed to study the side effects and best dose of nivolumab when given with ipilimumab. This combination was investigated for patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned or does not respond to treatment, or solid tumors that have spread or cannot be removed by surgery.
Trial design
The Phase 1 study (NCT02408861) was a dose de-escalation and dose expansion trial that enrolled 79 participants. The study investigated nivolumab and ipilimumab in patients with conditions including Advanced Malignant Solid Neoplasm, Anal Carcinoma, HIV Infection, Kaposi Sarcoma, and Lung Carcinoma. The trial's objective was to determine the side effects and best dose of nivolumab when administered with ipilimumab.
Key results
The trial results focused on the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and incidence of adverse events (AEs).
- The Maximum Tolerated Dose of nivolumab was determined to be 3 mg/kg in both the "Dose De-escalation Nivolumab 3 mg/kg (Stratum 1)" and "Dose De-escalation Nivolumab 3 mg/kg (Stratum 2)" groups.
- For Dose Limiting Toxicities (DLTs) observed in dose de-escalation cohorts:
- 0 participants experienced DLTs in "Dose De-escalation Nivolumab 3 mg/kg (Stratum 1)".
- 0 participants experienced DLTs in "Dose De-escalation Nivolumab 3 mg/kg (Stratum 2)".
- 1 participant experienced DLTs in "Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1)".
- 0 participants experienced DLTs in "Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2)".
- Incidence of Adverse Events (AEs) according to NCI CTCAE v5.0:
- "Dose De-escalation Nivolumab 3mg/kg (Stratum 1)" reported 27 Events.
- "Dose De-escalation Nivolumab 3mg/kg (Stratum 2)" reported 29 Events.
- "Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1)" reported 26 Events.
- "Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 2)" reported 8 Events.
- "Dose Expansion Nivolumab 240 mg q2w in Solid Tumors" reported 54 Events.
- "Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg" reported 72 Events.
Analyses of changes in CD4+ T-cell counts from baseline to the end of 46 cycles of treatment plus 6 weeks, using the Wilcoxon (Mann-Whitney) method, showed p-values ranging from 0.042 to 1 across different groups.
What this means
The results of this Phase 1 trial provide initial safety and tolerability data for nivolumab and ipilimumab in patients with HIV-associated cancers. The identification of a maximum tolerated dose of 3 mg/kg for nivolumab in de-escalation cohorts, coupled with a low number of dose-limiting toxicities, suggests a manageable safety profile for the investigated doses. The reported incidence of adverse events and the p-values for CD4+ T-cell count changes offer preliminary insights into the immunological impact and safety of this combination in a vulnerable patient population. These findings are crucial for informing the design of future studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02408861, titled "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," were posted on 2025-09-23 on clinicaltrials.gov.