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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.

Phase 1RecruitingValley Health SystemNCT05232409Data as of May 2026

Treatment: Zeaxanthin · Zeaxanthin Plus PembrolizumabThe 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.

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Extracted 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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