Phase 2 Melanoma 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 are willing and able to give informed consent to participate
• People who are 18 years of age or older at the time of signing the consent form
• People who have been diagnosed with non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), or melanoma, confirmed by laboratory testing of tissue or cells
• People who have at least one measurable area of cancer that has not been surgically removed, biopsied, or treated with radiation before joining the study
• People with locally advanced, inoperable, or cancer that has spread (metastatic) NSCLC, HNSCC, or melanoma, who have either never received immunotherapy (ICI) or whose cancer has stopped responding to it
• People with NSCLC who have never received immunotherapy, whose tumours do not have certain genetic changes (EGFR or ALK), and whose tumours show high levels of a protein called PD-L1 (TPS ≥50%) (confirm with trial site)
• People with HNSCC who have never received immunotherapy, whose tumours show PD-L1 expression at a certain level (CPS ≥20) (confirm with trial site)
• People with melanoma who have never received immunotherapy, regardless of PD-L1 levels or a specific gene mutation called BRAF V600
• People who have not previously received systemic treatment for their metastatic cancer, or who completed earlier preventative (adjuvant or neoadjuvant) treatment at least 6 months before their cancer spread
• People whose cancer has progressed after receiving at least 2 cycles of a type of immunotherapy (anti-PD-(L)1), and who have received fewer than three rounds of systemic treatment overall for their metastatic cancer
• People with a good general health and activity level, rated 0 or 1 on a standard scale used by doctors (ECOG performance status) (confirm with trial site)
• People who are willing to provide either stored tissue samples or a fresh tissue biopsy
• People whose organs (such as liver and kidneys) are functioning adequately
• People whose previous serious side effects from treatment have improved to a mild level or resolved

Who may not be able to join:

• People with NSCLC whose tumours have certain genetic changes (EGFR or ALK mutations)
• People with HNSCC whose cancer is specifically nasopharyngeal cancer (cancer in the upper part of the throat behind the nose)
• People who previously stopped immunotherapy due to severe immune-related side effects (Grade 3 or higher), if they are in the immunotherapy-refractory group
• People with untreated or uncontrolled cancer that has spread to the brain or the lining around the brain or spinal cord
• People with an active autoimmune disease that has required ongoing systemic medical treatment in the past 2 years
• People who have received a faecal (stool) transplant
• People currently participating in another clinical trial or who have used another experimental treatment within 30 days of signing consent
• People who cannot tolerate the contrast dye used in certain medical scans, if this cannot be managed with pre-medication
• People who are pregnant or breastfeeding
• Male participants who are unwilling or unable to use an acceptable method of contraception during the study
• People who are unable to swallow capsules
• People who have received a live vaccine within 4 weeks before the start of study treatment
• People with a known immune deficiency condition or who have had an organ transplant requiring ongoing immune-suppressing medication
• People who have received a blood transfusion or certain blood-stimulating medications within 1 week before the first dose of study treatment
• People who, in the opinion of the study doctor, are unlikely to be able to follow the study requirements
• People with active lung inflammation (interstitial lung disease or pneumonitis), or a history of this condition that required treatment with steroid medications
• People with a known allergy to clindamycin, erythromycin, or ampicillin (types of antibiotics)
• People showing signs or symptoms of bowel inflammation (colitis) at the time of screening
• People who have required systemic antibiotic, antifungal, or antiviral treatment for an infection within 14 days before starting study treatment (note: ongoing antiviral treatment for chronic hepatitis B or C may be permitted — confirm with trial site)
• People with untreated chronic hepatitis B, or hepatitis B carriers with virus levels above a certain threshold at screening (confirm with trial site for specific thresholds and exceptions)
• People with active hepatitis C infection (certain exceptions may apply depending on test results — confirm with trial site)
• People with a known history of HIV infection
• People with active inflammatory bowel disease that has caused diarrhoea in the past 12 months
• People who have had major surgery (other than a diagnostic biopsy) within 4 weeks of signing consent, or who have not fully recovered from surgery within that timeframe
• People with a history of major gastrointestinal surgery
• People with any condition, treatment history, or abnormal test result that could interfere with the study results (confirm with trial site)
• People with a currently active and clinically significant heart or blood vessel condition
• People with known active intravenous drug use, alcohol misuse, or use of other substances of abuse
• People for whom the immunotherapy drug pembrolizumab (Keytruda) is contraindicated based on its current prescribing information (confirm with trial site)

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