Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Kaposi sarcoma (KS) confirmed by a biopsy analysed at a specific laboratory (the Laboratory of Pathology, CCR).
• People whose KS has spread enough that doctors recommend systemic (whole-body) treatment, or whose KS is causing physical symptoms or significant emotional distress, even if they have not had prior KS treatment.
• People whose KS did not respond well enough to previous treatments such as liposomal doxorubicin, paclitaxel, other chemotherapy, or immunotherapy.
• People who have waited at least 2 weeks after their last chemotherapy, or at least 4 weeks after their last immunotherapy or biological treatment, before joining the trial.
• People whose side effects from any previous treatment have mostly resolved to a mild level or better.
• People who have at least five measurable KS skin lesions that have not been treated with radiation, surgery, or direct injections into the lesion.
• People whose KS can be measured using the criteria set out by the AIDS Clinical Trials Group (ACTG) Oncology Committee (confirm with trial site).
• People who are HIV-positive or HIV-negative — both are considered.
• People who are HIV-positive and have been on anti-HIV medication (ART) for at least 8 weeks before joining, with a low HIV viral load (under 400 copies/ml) and a minimum immune cell count (CD4+ T cell count of at least 50 cells per microlitre).
• People aged 18 years or older.
• People who are well enough to carry out basic daily activities, meeting a specific fitness level assessed by doctors (ECOG performance status of 2 or below, or Karnofsky score of 60% or above).
• People whose blood, liver, and kidney test results fall within acceptable ranges as required by the trial (confirm with trial site for specific values).
• People whose blood clotting test results are within acceptable ranges — this is required only for participants who will receive the study drug M7824 (confirm with trial site).
• People who are able to become pregnant, or people who could father a child, and who agree to use reliable contraception before, during, and for at least 4 months after treatment, and who agree to inform their treating doctor immediately if pregnancy occurs.
• People who are breastfeeding must agree to stop breastfeeding if treated with the study drugs.
• People who are able to understand the study and are willing to sign a written informed consent form.

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an investigational treatment.
• People who are pregnant, as the study drugs may harm a developing baby.
• People with severe KS — for example, KS affecting the lungs with symptoms — where the disease could become life-threatening within 2 to 4 weeks.
• People who have active bleeding caused by KS affecting internal organs.
• People who are unwilling to receive blood products if medically needed.
• People who have been actively bleeding or have needed a blood transfusion in the 2 weeks before joining the trial.
• People with a history of bleeding disorders or a significant bleeding event within the past 4 weeks that the trial doctor considers too high-risk for the study drugs.
• People with an active or recently symptomatic (within the last 3 months) autoimmune disease or a condition that required high-dose steroid or immune-suppressing medication — with some exceptions such as Type 1 diabetes, vitiligo, psoriasis, or thyroid conditions not requiring immune-suppressing treatment (confirm with trial site).
• People with infections that are not currently under control.
• People with active multicentric Castleman disease (a rare condition affecting the lymph nodes).
• People with primary effusion lymphoma (a rare type of blood cancer).
• People who have had another cancer, unless they have been fully free of that cancer for 3 or more years, or unless it was a type of skin cancer (basal cell or squamous cell) that was surgically removed, or cervical or anal pre-cancerous changes only.
• People who have had allergic reactions to drugs that are chemically or biologically similar to the study drugs PDS01ADC or M7824.
• People with active tuberculosis (TB) who are in their first month of TB treatment, or who are experiencing a TB-related immune reaction (IRIS) requiring steroids.
• People who have received, or will receive, a live vaccine within 30 days before starting the study — standard flu shots without live virus and locally approved COVID-19 vaccines are permitted.
• People with serious ongoing illness such as severe active infection, unstable heart conditions, or other conditions that would make it difficult to follow the trial requirements.
• People with a medical condition, mental health condition, or personal situation that, in the trial doctor's opinion, would prevent safe participation or the ability to give informed consent.
• People with an uncontrolled hepatitis B (HBV) infection detected by a blood test — however, people with past resolved HBV infection or HBV that is well controlled on appropriate medication are not excluded.
• People with an uncontrolled hepatitis C (HCV) infection detected by a blood test — however, people who have cleared HCV naturally or who have successfully completed HCV treatment are not excluded.
• People who stopped a previous PD-1/PD-L1 immunotherapy drug because of an immune-related side effect, or who have or have had a lung inflammation condition (pneumonitis) requiring steroids — these people would not be eligible for the combination therapy arm of the trial.

Important: Always verify eligibility with the trial site directly before applying.