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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
Female subjects of childbearing potential must be willing 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
Demonstration of adequate organ function as defined in Table 1 of the protocol
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 agree to use birth control during and up to 120 days after the study.
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My organs are functioning well according to the test results.
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I am 18 years old or older.
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I have taken a pregnancy test within the last 72 hours and it was negative.
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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 am willing and able to follow all study rules and attend all appointments.
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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
1,732 Previous Clinical Trials
2,143,522 Total Patients Enrolled
10 Trials studying Melanoma
320 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,545 Total Patients Enrolled
120 Trials studying Melanoma
21,656 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

Frequently Asked Questions

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

What are the benefits of Pembrolizumab with All-Trans Retinoic Acid?

"Pembrolizumab with All-Trans Retinoic Acid is most often used to treat melanoma that cannot be surgically removed. This medication can also offer relief for patients with microsatellite instability high, keratinization disorders of the feet, and high risk of recurrence."

Answered by AI

Does Pembrolizumab have any previous experience being studied with All-Trans Retinoic Acid?

"Presently, there are 1021 clinical trials researching the efficacy of pembrolizumab with all-trans retinoic acid. Out of these, 127 are in phase 3. Most of the pembrolizumab with all-trans retinoic acid trials are based in Houston, Texas; however, there are 36158 locations operating studies for pembrolizumab with all-trans retinoic acid."

Answered by AI

Who might be most helped by taking part in this experiment?

"Eligible patients for this melanoma study must be aged 18-100. A total of 26 patients will be enrolled in the clinical trial."

Answered by AI

Is this research study recruiting new participants?

"According to the latest update on clinicaltrials.gov, this particular trial is not searching for new patients. The trial was originally posted on October 31st, 2017 but was updated on November 1st, 2020. There are, however, 1802 other trials that are actively recruiting patients."

Answered by AI

Are patients above the age of 20 being recruited for this clinical trial?

"So long as they are over 18 and younger than 100, any adult can sign up for this clinical trial."

Answered by AI
~4 spots leftby Apr 2025