OncoMatch/Clinical Trials/NCT05232409
Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w/Pembrolizumab in Patients With Metastatic Cancer
Is NCT05232409 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Zeaxanthin and Zeaxanthin Plus Pembrolizumab for cancer metastatic.
Treatment: Zeaxanthin · Zeaxanthin Plus Pembrolizumab — The purpose of the research is to determine the highest dose of an oral compound called zeaxanthin that can be safely taken each day in patients with advanced cancer, the toxicity profile of zeaxanthin, and the dose of zeaxanthin to use in future cancer clinical trials.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage IV, UNRESECTABLE STAGE 3
Metastatic disease required
Stage IV or unresectable stage 3 histologically confirmed solid tumor malignancy
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: all standard therapies known to provide clinical benefit
refractory to all standard therapies known to provide clinical benefit (unless the therapy is contraindicated or intolerable) in the opinion of the treating investigator for his/her tumor type
Cannot have received: chemotherapy or radiotherapy
Exception: allowed if completed >21 days prior and recovered to grade 1 or less from adverse events (excluding alopecia, grade 2 fatigue, grade 2 hearing loss from platinum agent, and endocrinopathies on stable replacement therapy)
Patients who have had chemotherapy or radiotherapy within 21 days prior to initiating study treatment or those who have not recovered to grade 1 or less from adverse events due to agents administered more than 21 days earlier excluding alopecia, gd 2 fatigue, gd 2 hearing loss from platinum agent, and endocrinopathies on stable replacement therapy
Cannot have received: other investigational agents or concomitant chemotherapy or radiation therapy
Exception: hormonal therapy is not exclusionary
Patients may not be receiving any other investigational agents or concomitant chemotherapy or radiation therapy. Hormonal therapy is not exclusionary.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcl
Kidney function
Creatinine ≤ 1.5 x the institutional upper limit of normal
Liver function
Total bilirubin < 1.5 x the normal institutional limits excluding patients with confirmed Gilbert's syndrome; AST (SGOT)/ALT (SPGT) ≤ 3 x the institutional upper limit of normal
Adequate organ and marrow function as describe below: Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcl; Total bilirubin < 1.5 x the normal institutional limits excluding patients with confirmed Gilbert's syndrome; AST (SGOT)/ALT (SPGT) ≤ 3 x the institutional upper limit of normal; Creatinine ≤ 1.5 x the institutional upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Valley Hospital-Luckow Pavilion · Paramus, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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