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PD-1 Inhibitor

Rigosertib + Pembrolizumab for Skin Cancer

Phase 2

Recruiting

Led By Douglas Johnson, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Male/female participants who are at least 18 years of age with histologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests if a combo of 2 treatments could help treat melanoma that can't be removed or has spread, and hasn't responded to other treatments.

Who is the study for?

This trial is for adults with unresectable or metastatic cutaneous melanoma that hasn't improved after PD-1/L1 inhibitor treatment. Participants must have a good performance status, meet certain lab value criteria, and not be pregnant or breastfeeding. They should agree to use contraception and provide a tumor tissue sample. Those with severe psychiatric disorders, active infections, recent major surgery recovery issues, or specific cancer histories are excluded.Check my eligibility

What is being tested?

The study tests the combination of rigosertib (which may block enzymes needed for cell growth) and pembrolizumab (an immunotherapy drug), aiming to see if they're more effective together against advanced melanoma resistant to previous treatments compared to using them separately.See study design

What are the potential side effects?

Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue, possible changes in blood counts indicating bone marrow suppression, increased risk of infections due to immune modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 or older with a confirmed diagnosis of advanced skin cancer that cannot be surgically removed.

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My cancer has a BRAF V600 mutation and I've been treated with BRAF-targeted therapy.

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I am not pregnant, not breastfeeding, and either cannot become pregnant or will use birth control.

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I have provided a sample of my tumor that has not been treated with radiation.

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My cancer has worsened despite treatment with an anti-PD-1/L1 drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Overall response rate

Secondary outcome measures

Incidence of adverse events

Overall survival

Progression free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Rigosertib, pembrolizumab)Experimental Treatment5 Interventions

Patients receive rigosertib PO plus pembrolizumab IV throughout the study. Patients undergo CT or MRI and blood sample collection at screening and on study, and may also undergo tissue biopsy at screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1700

Biopsy

2014

Completed Phase 4

~1090

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,904 Total Patients Enrolled

Douglas Johnson, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05764395 — Phase 2

Cutaneous Melanoma Research Study Groups: Treatment (Rigosertib, pembrolizumab)

Cutaneous Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05764395 — Phase 2

Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764395 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned Rigosertib and pembrolizumab as viable treatments?

"This medication combination has been assigned a 2 on our risk scale, as the phase two trial does not provide sufficient evidence for efficacy yet still offers data indicating safety."

Answered by AI

Are there any vacancies open for participants in this trial?

"Per clinicaltrials.gov, this medical research is no longer open to new participants as the last update was on February 28th 2023. Despite that there are 828 other trials actively recruiting right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors

Douglas Johnson 2023. "Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05764395.