Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer

Summary

This phase I trial studies the side effects of pembrolizumab in treating patients with human immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not respond to treatment (refractory), or have distributed over a large area in the body (disseminated). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Timeline

Start

2016-04-04

Primary completion

2023-10-04

Completion

2024-03-25

Publications

• Talla A, Azevedo JLLC, Latif MB, Enriquez AB, Sanchez GP, Pelletier AN, Bal SK, Kumari S, Schuch V, Ghneim K, Rhodes A, Maldarelli F, Yarchoan R, Lurain K, Ramaswami R, Sharon E, Hess BW, D'Amico L, Martinez-Picado J, Chomont N, Lewin SR, Deeks SG, Fling SP, Cheever MA, Uldrick TS, Sharma AA, Sekaly RP. Innate antiviral and immune functions associated with the HIV reservoir decay after anti-PD-1 therapy. Nat Med. 2026 Feb;32(2):505-517. doi: 10.1038/s41591-025-04139-y. Epub 2026 Feb 12.
• Lurain K, Ramaswami R, Ekwede I, Eulo V, Goyal G, Menon M, Odeny TA, Sharon E, Wagner MJ, Wang CJ, Bhardwaj N, Friedlander PA, Abdul-Hay M, Cornejo Castro EM, Labo N, Marshall VA, Miley W, Moore K, Roshan R, Whitby D, Kask AS, Kaiser J, Han E, Wright A, Yarchoan R, Fling SP, Uldrick TS. Cancer Immunotherapy Trials Network 12: Pembrolizumab in HIV-Associated Kaposi Sarcoma. J Clin Oncol. 2025 Feb;43(4):432-442. doi: 10.1200/JCO.24.00640. Epub 2024 Oct 2.
• Uldrick TS, Adams SV, Fromentin R, Roche M, Fling SP, Goncalves PH, Lurain K, Ramaswami R, Wang CJ, Gorelick RJ, Welker JL, O'Donoghue L, Choudhary H, Lifson JD, Rasmussen TA, Rhodes A, Tumpach C, Yarchoan R, Maldarelli F, Cheever MA, Sekaly R, Chomont N, Deeks SG, Lewin SR. Pembrolizumab induces HIV latency reversal in people living with HIV and cancer on antiretroviral therapy. Sci Transl Med. 2022 Jan 26;14(629):eabl3836. doi: 10.1126/scitranslmed.abl3836. Epub 2022 Jan 26.
• Uldrick TS, Goncalves PH, Abdul-Hay M, Claeys AJ, Emu B, Ernstoff MS, Fling SP, Fong L, Kaiser JC, Lacroix AM, Lee SY, Lundgren LM, Lurain K, Parsons CH, Peeramsetti S, Ramaswami R, Sharon E, Sznol M, Wang CJ, Yarchoan R, Cheever MA; Cancer Immunotherapy Trials Network (CITN)-12 Study Team. Assessment of the Safety of Pembrolizumab in Patients With HIV and Advanced Cancer-A Phase 1 Study. JAMA Oncol. 2019 Sep 1;5(9):1332-1339. doi: 10.1001/jamaoncol.2019.2244.

Drugs

Indications