Phase 2 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:

• People aged 18 or older who have signed a consent form before any study procedures begin.
• People who have been diagnosed (confirmed by tissue testing) with a carcinoma, sarcoma, or melanoma that has spread or is locally advanced and cannot be treated with curative local therapy (for the main study parts); or people with advanced cutaneous squamous cell skin cancer (CSCC) or platinum-resistant ovarian cancer (PROC) for certain expansion groups (confirm with trial site which group applies).
• People whose cancer has continued to grow despite standard treatments, or who could not tolerate standard treatments, or whose doctor considers them medically unsuitable for standard treatments, with no remaining proven curative options — requirements vary by study group (confirm with trial site).
• For certain groups: people who have previously received a specific type of immunotherapy called a PD-(L)1 inhibitor for at least 12 weeks, with additional prior therapy requirements depending on the group (confirm with trial site which group applies).
• For the CSCC group: people who have previously received a PD-(L)1 inhibitor and have not received any additional immunotherapy.
• For the PROC group: people who have received platinum-based chemotherapy and whose cancer progressed during or within 6 months of finishing that treatment.
• People whose cancer can be measured on scans according to standard criteria (RECIST v1.1).
• People of childbearing potential who are willing to use at least one highly effective form of contraception for at least one menstrual cycle before and for 4 months after receiving the study treatment (this applies to both female participants and male participants with partners of childbearing potential), unless they have not had a period for at least 12 consecutive months or have had a surgical procedure that prevents pregnancy.
• People whose side effects from previous treatments have largely resolved to a mild level (Grade 1 or lower), with some exceptions such as hair loss or mild nerve-related symptoms, and who have not needed treatment for those side effects for at least 2 weeks before joining.
• People who have waited at least 2 weeks since their last hormone therapy, and at least 3 weeks since their last cancer treatment or radiotherapy (or 4 weeks for certain types of therapy), before starting the study.
• People whose liver, kidneys, and other organs are functioning adequately (confirm with trial site for specific values).
• People who are able to provide a stored tumour tissue sample, or who may still be considered if no stored sample is available with approval from the medical monitor.
• People in one specific group (Cohort B1) who agree to have tumour biopsies taken before and during the study; in all other groups, biopsies are optional.
• People who are willing and able to follow the study procedures and requirements.
• People who meet any social security or health insurance affiliation requirements set by local laws or regulations (confirm with trial site).

Who may not be able to join:

• People who have previously had a severe allergic reaction to another monoclonal antibody treatment.
• People whose life expectancy is estimated to be less than 12 weeks.
• People whose general physical functioning is too limited, as rated above level 2 on a standard performance scale used by doctors (confirm with trial site).
• People who have previously had an organ transplant or stem cell transplant.
• People with fluid build-up in the abdomen or around the lungs that is causing symptoms, unless they have been stable for at least 2 weeks after treatment for those conditions.
• People with active brain tumours or cancer that has spread to the brain or the lining of the brain, unless the brain metastases were previously treated and the person has been stable for at least 4 weeks, with no new or growing brain lesions on scans, and is on little or no steroid medication.
• People with a history of blood cancer, a primary brain tumour, or another separate solid tumour, unless there has been no sign of that cancer returning for at least 3 years after curative treatment — with some exceptions for early-stage or certain skin cancers (confirm with trial site).
• People with serious active infections, including severe viral, bacterial, or fungal infections within the past 2 weeks; uncontrolled HIV (though people with well-controlled HIV on stable treatment may be eligible); active or chronic hepatitis B (though people on treatment with undetectable virus for at least 6 months may be eligible); active hepatitis C (though people who are virus-free for at least 6 months after treatment may be eligible); or active or latent tuberculosis.
• People with an autoimmune or inflammatory condition that requires ongoing whole-body anti-inflammatory treatment, with some exceptions such as hormone replacement for autoimmune-related hormonal conditions.
• People who have taken systemic steroids in the past 15 days or other immune-suppressing medications in the past 30 days, unless the steroids are at a very low replacement dose.
• People with a particular heart rhythm measurement (QTc interval of 470 milliseconds or more) on an ECG.
• People who have taken part in another clinical trial or used an investigational device within the past 30 days.
• People who have received a live vaccine within the past 30 days.
• For certain study groups (A2, B1, B2, B3): people with a known allergy to the drug cemiplimab; people with a lung condition called interstitial lung disease; people who previously needed steroid treatment for lung inflammation caused by a prior treatment; people currently on immune-suppressing therapy (with exceptions); or people who had severe immune-related side effects from a prior immunotherapy drug called ipilimumab.
• People currently receiving other cancer treatments, with the exception of certain hormonal therapies as described in the inclusion criteria.
• People with serious medical or surgical conditions that a doctor judges could interfere with the study or put them at additional risk, including significant heart, lung, kidney, liver, neurological, or psychiatric conditions, or active substance misuse disorders.
• People who have had a recent history of chronic substance misuse in the year before signing the consent form.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period.
• People in legally protected or vulnerable categories, including those under legal guardianship, those detained by court or administrative order, those receiving psychiatric care without their consent, or those unable to give their own consent.

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