Phase 1 Melanoma Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older.
• People whose general physical functioning is rated at a level showing they are able to care for themselves, even if unable to carry out strenuous activity (confirm with trial site regarding the specific rating scale used).
• People whose blood test results meet certain minimum standards for red blood cells, platelets, white blood cells, liver function, and kidney function (the trial site can confirm the specific required values).
• People whose cancer can be measured and whose tumour tissue can be surgically sampled for use in preparing the study treatment.
• People with only one active cancer at the time of joining (people with a previous or additional cancer may still be considered if the treating doctor and trial leadership determine it will not affect safety or the study results).
• People who provide written consent to participate.
• People who could become pregnant must have a negative blood pregnancy test before joining.
• People who could become pregnant must use an adequate method of contraception throughout the study and for at least four months after the last dose of study treatment.
• People whose partners could become pregnant must agree to use doctor-approved contraception throughout the study and for four months after the last dose, and must agree not to donate sperm during treatment or for four months after the last dose.

For people with melanoma, additional criteria apply. People who may be considered include those who:

• Have stage II, III, or surgically removed stage IV melanoma and received a type of immunotherapy called anti-PD-1 therapy (alone or in combination) before or after surgery, and whose disease got worse during treatment or within 6 months of finishing the planned course.
• Stopped anti-PD-1 therapy early due to side effects and whose disease came back within 6 months of stopping.
• Received anti-PD-1 therapy before surgery (with or without follow-up therapy after surgery) and whose disease got worse during treatment or within 6 months of finishing or stopping.
• Received a short course of anti-PD-1 therapy before surgery, were then monitored after surgery, and whose disease came back within 6 months of finishing that pre-surgery treatment.
• Have melanoma that cannot be surgically removed or has spread widely (stage IV) and whose disease got worse while receiving anti-PD-1 therapy in any line of treatment.
• Have stage IV melanoma, completed a planned course of anti-PD-1 therapy (whether planned for approximately one or two years), and whose disease got worse within 6 months of finishing or stopping early due to side effects.
• Have any subtype of melanoma, including skin-based and non-skin-based types such as uveal, mucosal, and acral lentiginous melanoma.
• Have no medical reason preventing continued immune checkpoint therapy, do not have rapidly worsening disease requiring urgent alternative treatment, and have no other currently approved treatment options available to them, or have declined currently approved options.

For people with soft tissue sarcoma, additional criteria apply. People who may be considered include those who:

• Have a type of sarcoma confirmed by a specialist pathologist based on the appearance of the cancer cells under a microscope.
• Have disease that has continued to grow or has stopped responding to treatment, as determined by their treating doctor.
• Have disease that can be measured using standard imaging criteria.
• Have a sarcoma that started in a soft tissue location, such as fatty tissue, muscle, or skin.
• Have unresectable (cannot be surgically removed) stage II, stage III, or stage IV disease.
• Have previously received a type of immunotherapy called an immune checkpoint inhibitor, or have not received one, unless it is considered a standard part of their care as recognised by the FDA.

Who may not be able to join:

• People with an active second cancer, although people whose early-stage cancer was previously treated with no signs of return after 3 years of follow-up may still be considered.
• People who previously stopped anti-PD-1 immunotherapy due to serious immune-related side effects, or who have had a severe allergic reaction to any monoclonal antibody treatment, or who have other factors that in the investigator's opinion make continued use of this type of therapy unsafe.
• People with active and symptomatic cancer spread to the brain or the lining of the brain at the time of joining (people who previously had isolated brain lesions treated with targeted radiation or surgery before starting immunotherapy may be considered, as long as there is no new disease and they have no symptoms at the time of joining).
• People who received another experimental drug in a different clinical trial within the past 28 days, or within 5 half-lives of that drug, whichever is shorter.
• People who required steroid medications above a low daily dose, or other immune-suppressing medications, within 14 days before starting the trial treatment.
• People with a known active infection or a condition that weakens the immune system within 7 days before tumour tissue collection or within 7 days before receiving the study vaccine (people taking preventive medications may still be considered).
• People with any other serious illness or medical condition unrelated to their cancer that the investigator believes could put them at risk.
• People with known active hepatitis B virus infection, or untreated hepatitis C virus infection (people who have been successfully treated for hepatitis C with no detectable virus remaining are not excluded).
• People with HIV who have a low immune cell count, a detectable level of the virus in their blood, or a history of a serious HIV-related infection within the past 12 months.
• People with a known active autoimmune disease that could become life-threatening if it flared up during treatment (people with certain chronic autoimmune conditions affecting joints, hormones, or skin may still be considered if they are not taking immune-suppressing medications and are aware of the risk).
• People with moderate to severe heart failure.
• People with unstable chest pain (unstable angina).
• People with unstable heart rhythm problems or who have had a full-thickness heart attack within the past 6 months.
• People who have had their spleen removed, have no functioning spleen, or have a significantly enlarged spleen.
• People with a personal history of a severe allergic (anaphylactic) reaction to a previous vaccine.
• People with a known allergy to the study treatment or any of its ingredients.
• People who could become pregnant and are unwilling or unable to use an acceptable method of contraception throughout the study and for at least 4 months after the last dose.
• People who are confirmed to be pregnant or are breastfeeding.
• People with any other known medical condition, test finding, or health history that the treating doctor believes makes the study treatment unsafe for them or could affect the interpretation of study results.
• People who received a vaccine containing a live virus within 30 days before the first dose of trial treatment (most standard flu vaccines are not live, but the nasal spray flu vaccine is and is not permitted within this window; standard non-live COVID vaccines are allowed).
• People who are prisoners, involuntarily incarcerated, or compulsorily detained for treatment of a psychiatric or physical illness.
• People whose sarcoma originated in bone or cartilage.
• People with types of sarcoma that do not typically spread to other parts of the body, such as well-differentiated liposarcoma, dermatofibrosarcoma protuberans, or desmoid fibromatosis.

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