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

Conditions

• Advanced Malignant Solid Neoplasm
• Anal Carcinoma
• HIV Infection
• HIV-associated Cancers
• Kaposi Sarcoma
• Lung Carcinoma
• Metastatic Malignant Solid Neoplasm
• Recurrent Classic Hodgkin Lymphoma
• Refractory Classic Hodgkin Lymphoma
• Unresectable Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Ipilimumab — BIOLOGICAL
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET scan

Study Details

This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory), or solid tumors that have spread from where it first started to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ipilimumab is an antibody that acts against a molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of the immune system by shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV associated classical Hodgkin lymphoma or solid tumors compared to ipilimumab with nivolumab alone.

Key Dates

Start date

Oct 21, 2015

Status verified

Sep 2025

Primary completion

May 1, 2024

Completion

Aug 31, 2024

Study Design

Enrollment

79 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose De-escalation Single Agent Nivolumab Stratum 1
  Stratum 1 will enroll participants with T lymphocyte CD4+ count above 200/mm3. Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.
• Experimental: Dose De-escalation Single Agent Nivolumab Stratum 2
  Stratum 2 will enroll participants with T lymphocyte CD4+ count between 100 to 200/mm3. Stratum 2 will start enrolling after completion of stratum 2 dose deescalation. The dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.
• Experimental: Dose De-escalation Cohort Combination Therapy (Nivolumab and Ipilimumab) Stratum 1
  Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.
• Experimental: Dose De-escalation Cohort Combination Therapy (Nivolumab and Ipilimumab) Stratum 2
  Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.
• Experimental: Solid Tumors Dose Expansion Cohort Single Agent Nivolumab
  Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.
• Experimental: Combination Regimen Expansion Cohort
  The combination therapy at MTD of Nivolumab and Ipilimumab regimen will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.
• Experimental: Classical Hodgkin Lymphoma Cohort
  Single agent Nivolumab therapy at MTD dose from dose-de-escalation will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.

Primary Outcome Measure

Maximum Tolerated Dose of Nivolumab [ Time Frame: Each patient will be evaluated for DLT for the safety evaluation period of 6 weeks ]

Locations (32)

Related coverage on Hipa.ai

• Nivolumab/Ipilimumab Phase 1 Trial in HIV-Associated Cancers Shows Tolerability
  Nivolumab · Sep 23, 2025 · ClinicalTrials.gov

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