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Pembrolizumab + All-Trans Retinoic Acid for Melanoma

Phase 1 & 2
Waitlist Available
Led By Martin McCarter, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years on day of signing informed consent
Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in the protocol for the course of the study through 120 days after the last dose of study medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines VESANOID with pembrolizumab.

Who is the study for?
Adults with advanced melanoma (unresectable Stage III or IV) who plan to undergo pembrolizumab treatment, can consent, follow trial procedures for its duration, and use contraception. Excluded are those with recent cancer treatments, active infections, pregnancy/breastfeeding intentions during the trial, prior anti-PD-1/L1/L2 therapy, immunodeficiency or suppressive therapy within 7 days of starting the trial.Check my eligibility
What is being tested?
This Phase I/Ib open-label study tests a combination of VESANOID (All-Trans Retinoic Acid) and pembrolizumab in treating advanced melanoma. It aims to understand how well these drugs work together and their safety profile in patients.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs like lungs or liver (pneumonitis/hepatitis), infusion reactions from pembrolizumab administration, fatigue, skin issues due to retinoids such as dryness or rash; exact side effects will be monitored throughout the study.

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 am a man who can father children and agree to use birth control during and for 4 months after the study.
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I am scheduled to receive pembrolizumab as my standard treatment.
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I have advanced melanoma that cannot be surgically removed.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximally Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of All-Trans Retinoic Acid
Maximally Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Pembrolizumab
Secondary outcome measures
Number of Patients With a Dose-Limiting Toxicity (DLT) for the Combined Treatment of Pembrolizumab and All-Trans Retinoic Acid
Percent Change in Anti-Tumor Activity
Progression Free Survival
Other outcome measures
The anti-tumor activity for each patient

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with All-Trans Retinoic AcidExperimental Treatment1 Intervention
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,752 Previous Clinical Trials
2,165,573 Total Patients Enrolled
10 Trials studying Melanoma
320 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,908 Previous Clinical Trials
5,066,661 Total Patients Enrolled
120 Trials studying Melanoma
22,173 Patients Enrolled for Melanoma
Martin McCarter, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Melanoma
10 Patients Enrolled for Melanoma
~3 spots leftby Jun 2025
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