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Monoclonal Antibodies

Zeaxanthin + Pembrolizumab for Advanced Cancer

Phase 1
Recruiting
Led By Philip Friedlander, MD
Research Sponsored by Valley Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years.
Performance status ECOG 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial tests the safety and dosage of an oral compound to treat advanced cancer. Results will help in future trials.

Who is the study for?
Adults with advanced cancer that's spread and doesn't respond to standard treatments can join. They must have good liver, kidney, and blood health, be able to use birth control, and not be pregnant. People with a performance status showing they're still up and about (ECOG 0-2) are eligible.Check my eligibility
What is being tested?
The trial is testing the highest safe dose of zeaxanthin taken orally by itself or combined with Pembrolizumab for metastatic cancer patients. It aims to find out what side effects occur and decide on a dose for future trials.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system due to Pembrolizumab such as fatigue, skin issues, diarrhea; Zeaxanthin's specific side effects will be studied but may involve stomach upset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Zeaxanthin monotherapy
Zeaxanthin monotherapy (continued)
Zeaxanthin plus Pembrolizumab
+1 more
Secondary outcome measures
Area under the curve (AUC) of zeaxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin
Area under the curve (AUC) of zeaxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab
The disease control rate (DCR) in patients with unresectable advanced solid tumors treated with zeaxanthin
+9 more
Other outcome measures
Changes in blood transcriptome in patients with unresectable advanced solid tumors treated with zeaxanthin
Changes in blood transcriptome in patients with unresectable advanced solid tumors treated with zeaxanthin plus zeaxanthin
On treatment biopsy for evidence of increased immune cell infiltration and vascularization to zeaxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Zeaxanthin plus PembrolizumabExperimental Treatment1 Intervention
Zeaxanthin administered orally on daily basis in addition to intravenous pembrolizumab infused every 42 days at fixed dose of 400 mg.
Group II: Zeaxanthin MonotherapyExperimental Treatment1 Intervention
Zeaxanthin administered orally on daily basis.

Find a Location

Who is running the clinical trial?

Valley Health SystemLead Sponsor
9 Previous Clinical Trials
1,821 Total Patients Enrolled
Philip Friedlander, MDPrincipal InvestigatorThe Valley Hospital
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05232409 — Phase 1
Metastatic Tumor Research Study Groups: Zeaxanthin Monotherapy, Zeaxanthin plus Pembrolizumab
Metastatic Tumor Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05232409 — Phase 1
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05232409 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients still enroll in this research program?

"Data posted on clinicaltrials.gov reveals that recruitment is still open for this medical trial, which was first advertised to the public in April 2022 and most recently updated a year later."

Answered by AI

Is my profile fitting for involvement in this medical experiment?

"This research endeavour seeks 72 individuals with metastatic tumors, aged 18 to 99. Notably, all participants must meet the inclusion criteria for dose escalation of zeaxanthin monotherapy."

Answered by AI

Has Zeaxanthin Monotherapy gained regulatory clearance?

"Assessed on a scale of 1 to 3, the safety rating for Zeaxanthin Monotherapy is estimated at one due to it being an early-phase trial with limited evidence supporting its efficacy and safety."

Answered by AI

Is eligibility for this experiment limited to persons over the age of 65?

"The requirements to be eligible for this trial demand that applicants are aged 18-99. In addition, 15 clinical trials exist specifically for minors and 229 studies encompass seniors of 65 years or older."

Answered by AI

How many individuals are projected to be recruited for this clinical research endeavor?

"Indeed, the data hosted on clinicaltrials.gov reveals that this medical examination is still in progress, having been initially posted on April 17th 2022 and recently updated on April 19th 2023. The trial requires 72 participants to be recruited at a single site."

Answered by AI

What are the objectives of this research endeavor?

"The primary objective of this clinical trial, which runs for approximately 20 weeks per dosing cohort, is to assess the efficacy of zeaxanthin monotherapy. Secondary endpoints include response rate (ORR) as measured by RECIST v1.1, progression free survival (PFS), and duration of response in patients with unresectable advanced solid tumors; all results will be evaluated at 2-month and 6-month intervals after treatment commencement. Additionally, disease control rate (percentage of participants achieving complete/partial remission or stable illness) will also be gauged."

Answered by AI
~21 spots leftby Mar 2025