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:

Criteria that apply to all groups:

• Adults aged 18 or older who are willing and able to provide written consent to participate.
• People whose cancer can be detected through physical examination, standard imaging scans, or PET scans.
• People whose cancer can be completely surgically removed, meaning no significant involvement of major blood vessels, the brain or spinal cord, or bones, and where surgery can safely achieve clear margins (no cancer left behind).
• People who have both a primary tumour and nearby lymph node involvement, provided all of it can be fully removed by surgery.
• People with up to 3 "in-transit" tumours (cancer that has spread through the lymphatic system but not yet reached distant lymph nodes), as long as all can be fully removed.
• People whose tumour can be biopsied (a small tissue sample taken) to run a specialised set of tests called a multi-omic biomarker analysis.
• People who are in good general health, able to carry out normal daily activities with no more than minor limitations (confirm with trial site for exact fitness level required).
• People with adequate blood counts and liver, kidney, and hormone gland function.
• People who are expected to live for more than 12 months.
• Women who could become pregnant must agree not to become pregnant or breastfeed during the study treatment period.

Additional criteria for Group 1 (Cohort 1) only:

• People with a laboratory-confirmed diagnosis of skin melanoma or melanoma with no known starting point (unknown primary).
• People whose melanoma is classified as Stage IIIB, IIIC, or IIID according to standard cancer staging guidelines (AJCC 8th Edition).
• People who have not previously received any systemic (whole-body) treatment for skin melanoma.
• People who are able to complete the specialised biomarker testing within 14 days before the planned start of the study.

Additional criteria for Group 2 (Cohort 2) only:

• People with a laboratory-confirmed diagnosis of skin melanoma or melanoma with no known starting point.
• People whose melanoma is classified as Stage IIIB, IIIC, or IIID.
• People whose melanoma got worse while receiving a specific type of immunotherapy drug (anti-PD-1) given before surgery, where the worsened disease can still be fully removed — or people whose melanoma came back after receiving anti-PD-1 immunotherapy given after surgery, where the returning disease can be fully removed.
• People who have not previously been treated with CTLA-4 or LAG-3 inhibitor drugs (confirm with trial site if unsure which drugs these refer to).

Additional criteria for Group 3 (Cohort 3) only:

• People with a laboratory-confirmed diagnosis of mucosal melanoma (melanoma that starts in the moist lining of body cavities, such as the mouth, nose, or digestive tract).
• People at any stage of this type of melanoma, provided it can be completely removed by surgery.
• People who have not previously received any systemic (whole-body) treatment for mucosal melanoma.

Who may not be able to join:

• People with uveal melanoma (melanoma that starts in the eye).
• People for whom any of the study drugs — relatlimab, ipilimumab, or nivolumab — would be medically unsuitable.
• People in Groups 1 and 3 who have previously received any systemic cancer treatment, including immunotherapy drugs such as anti-PD-1/PD-L1, anti-CTLA-4, or anti-LAG-3 therapies.
• People who have a condition causing a weakened immune system, or who are currently taking high-dose steroid medications (above the equivalent of 10 mg of prednisone per day) or other immune-suppressing medications within 14 days before joining the study — though certain replacement hormone therapies, low-dose inhaled or nasal steroids, and non-absorbed joint injections may be permitted (confirm with trial site).
• People with an active autoimmune disease (where the immune system attacks the body) that has needed systemic treatment within the past 12 months — though certain conditions such as vitiligo, Type 1 diabetes, stable underactive thyroid, childhood asthma that has resolved, psoriasis not needing systemic treatment, and some other autoimmune conditions may be permitted (confirm with trial site).
• People with another cancer that is currently active or has required treatment within the past 3 years — though certain cancers that have been successfully and completely treated (such as some skin cancers, early-stage cancers, or cancers for which the person has been disease-free for at least one year) may be permitted (confirm with trial site).
• People with known cancer that has spread to the brain or the lining around the brain or spinal cord.
• People with a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease) that required steroid treatment, or who currently have either of these conditions.
• People who currently have an active infection that requires systemic (whole-body) treatment.
• People with a known history of HIV infection.
• People with a known history of active Hepatitis B or Hepatitis C infection.
• People with a known history of active tuberculosis (TB).
• People with serious or poorly controlled heart or blood vessel conditions, including: a heart attack or stroke within the past 6 months; uncontrolled chest pain within the past 3 months; significant heart rhythm problems; a specific electrical abnormality in the heart (QTc prolongation above 480 ms); serious heart muscle or valve conditions; a need for daily supplemental oxygen due to heart or blood vessel disease; two or more past heart attacks or two or more artery-clearing procedures; or any history of heart muscle inflammation (myocarditis).
• People with higher-than-acceptable levels of protein in their urine, unless further testing confirms the level is within an acceptable range (confirm with trial site for details).
• People with any other medical condition, treatment, or test result that the treating doctor believes could interfere with the study results or would make participation not in the person's best interest.
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the study requirements.
• Women who are pregnant or currently breastfeeding.
• People with medical or personal circumstances that would prevent them from attending all required study visits and assessments.

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