Study on NHS-IL12 Alone and with M7824 for Advanced Kaposi Sarcoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04303117

Provider View

This clinical trial is exploring whether two non-chemotherapy drugs, NHS-IL12 and M7824, can help the immune system fight Kaposi Sarcoma (KS) tumors in adults who have previously received treatment.

Patient Parameters

Program Overview

Kaposi Sarcoma (KS) is a type of cancer that can affect the skin, lymph nodes, lungs, bones, and digestive system. It often occurs in people with weakened immune systems, such as those with HIV or a history of organ transplants. This study is testing two drugs, NHS-IL12 and M7824, to see if they can help the immune system fight KS. NHS-IL12 helps activate the immune system, while M7824 blocks cancer cells from stopping the immune response. The study aims to find out if these drugs, alone or together, can help treat KS.

Description

Kaposi Sarcoma (KS) is a cancer that often affects the skin but can also involve other parts of the body like the lymph nodes, lungs, and digestive system. It is more common in people with HIV but can also occur in those without HIV. KS can be a long-term condition that requires ongoing treatment.

This study is testing two drugs, NHS-IL12 and M7824, to see if they can help the immune system fight KS. NHS-IL12 is designed to target and activate the immune system at the tumor site, while M7824 is a drug that blocks pathways cancer cells use to evade the immune system.

The study will evaluate the safety and effectiveness of these drugs in people with advanced KS who have already received other treatments. Participants will receive NHS-IL12 alone or in combination with M7824 for up to 96 weeks. The study will monitor how well the drugs work and any side effects. Participants will have regular check-ups and tests to assess their health and the impact of the treatment.

The study includes follow-up visits after treatment ends to continue monitoring participants' health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with confirmed Kaposi Sarcoma (KS).
  • KS that requires systemic treatment and has been treated before.
  • At least five measurable skin lesions from KS.
  • Able to perform daily activities with some limitations (ECOG status 0-2).
  • Willing to provide informed consent.
  • HIV-positive participants must have been on antiretroviral therapy for at least 8 weeks, with controlled viral load and adequate CD4+ T-cell count.
  • Adequate organ and blood function as determined by specific medical tests.
  • Willing to use effective birth control during and after the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Currently receiving other investigational treatments.
  • Pregnant or breastfeeding women.
  • Severe KS that could worsen quickly.
  • Actively bleeding KS lesions or recent major bleeding events.
  • History of severe allergic reactions to similar drugs.
  • Active tuberculosis or recent live vaccine.
  • Uncontrolled infections or serious medical conditions.
  • Uncontrolled hepatitis B or C infections.
  • Participants with a history of stopping PD1/L1 drugs due to side effects or with lung inflammation will be excluded from the combination therapy arm.

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