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Zeaxanthin with or without Pembrolizumab for Metastatic Cancer

This study is looking into the safety and best dose of a compound called zeaxanthin, given alone or with pembrolizumab, for people with metastatic cancer (cancer that has spread). The main goal is to find the highest dose of zeaxanthin that can be safely taken and to understand its side effects. You may be eligible if you are 18 to 99 years old and have advanced solid tumor cancer that has not responded to standard treatments. The study will also look at how these treatments might affect tumor growth. This trial plans to enroll up to 72 participants, but its current recruitment status is unclear.

Study design
This interventional study will enroll up to 72 participants. It uses a 3+3 design, meaning groups of three patients will receive increasing doses of zeaxanthin until the safest dose is found.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants receiving zeaxanthin alone or with pembrolizumab will be monitored for up to 20 weeks for each dosing group, and for toxicities within 28 days of starting zeaxanthin.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05232409

Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w/Pembrolizumab in Patients With Metastatic Cancer

Recruiting
PHASE1Ages 18–99InterventionalTreatment
Valley Health System
~72 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:ZeaxanthinZeaxanthin Plus Pembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Zeaxanthin monotherapy
Measured over Up to 20 weeks for each dosing cohort
+3 more outcomes measured

Conditions

Cancer Metastatic
Metastatic Solid Tumor

Explore related trials

Solid Neoplasm

NCT05232409

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Valley Hospital-Luckow Pavilion

    Paramus, New Jerseystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Philip Friedlander, MD · PRINCIPAL_INVESTIGATOR · The Valley Hospital

Who to contact

Sequoia Young, MS
[email protected]
201-634-5792
Email the study team

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Eligibility criteria

Inclusion

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 (ULN)
Creatinine ≤ 1.5 x the institutional upper limit of normal 5. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Absolute neutrophil count ≥ 1,500/mcL
Platelets ≥ 100,000/mcl
Total bilirubin) ≤ 1.5 x normal institutional limits excluding patients with confirmed Gilbert's syndrome
AST (SGOT)/ALT (SPGT) ≤ 3 x institutional upper limit of normal
Creatinine ≤ 1.5 x the institutional upper limit of normal 6. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

What this trial measures

  • Zeaxanthin monotherapyUp to 20 weeks for each dosing cohort

    Recommended maximum tolerated dose Highest dose of zeaxanthin that does not cause dose limiting toxicity in patients with unresectable advanced solid tumors treated with zeaxanthin

  • Zeaxanthin monotherapy (continued)Toxicities experienced within 28 days of zeoxanthin initiation

    Rate of Dose Limiting Toxicity (DLT) Based on CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) in patients with unresectable advanced solid tumors treated with zeaxanthin

  • Zeaxanthin plus PembrolizumabUp to 20 weeks for each dosing cohort

    Recommended maximum tolerated dose Highest dose of zeoxanthin that does not cause dose limiting toxicity in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab

  • Zeaxanthin plus Pembrolizumab (continued)Toxicities experienced within 42 days of zeaxanthin plus pembrolizumab initiation

    Rate of Dose Limiting Toxicity (DLT) Based on CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab