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

Summary

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.

Timeline

Start

2015-10-21

Primary completion

2024-05-01

Completion

2024-08-31

Outcome

Outcome not reported

Stopped (Enrollment): “Inadequate accrual rate”

Publications

• Rajdev L, Jackie Wang CC, Joshi H, Lensing S, Lee J, Ramos JC, Baiocchi R, Ratner L, Rubinstein PG, Ambinder R, Henry D, Streicher H, Little RF, Chiao E, Dittmer DP, Einstein MH, Cesarman E, Mitsuyasu R, Sparano JA; AIDS Malignancy Consortium. Assessment of the safety of nivolumab in people living with HIV with advanced cancer on antiretroviral therapy: the AIDS Malignancy Consortium 095 Study. Cancer. 2024 Mar 15;130(6):985-994. doi: 10.1002/cncr.35110. Epub 2023 Nov 14.
• Rasmussen TA, Rajdev L, Rhodes A, Dantanarayana A, Tennakoon S, Chea S, Spelman T, Lensing S, Rutishauser R, Bakkour S, Busch M, Siliciano JD, Siliciano RF, Einstein MH, Dittmer DP, Chiao E, Deeks SG, Durand C, Lewin SR. Impact of Anti-PD-1 and Anti-CTLA-4 on the Human Immunodeficiency Virus (HIV) Reservoir in People Living With HIV With Cancer on Antiretroviral Therapy: The AIDS Malignancy Consortium 095 Study. Clin Infect Dis. 2021 Oct 5;73(7):e1973-e1981. doi: 10.1093/cid/ciaa1530.

Drugs

Indications