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Rigosertib + Pembrolizumab for Skin Cancer

VS
Overseen ByVanderbilt-Ingram Services for Timely Access
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining rigosertib with pembrolizumab can more effectively treat skin cancer that cannot be surgically removed or has metastasized, particularly when previous treatments have failed. Rigosertib may inhibit tumor growth and enhance the immune system's ability to combat cancer, while pembrolizumab (also known as KEYTRUDA) is designed to help the immune system attack cancer cells. Individuals with melanoma that has not responded to certain prior treatments and impacts their daily life may be suitable candidates for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain cancer treatments or vaccines recently, and you should not be on high-dose steroids or immunosuppressive therapy. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rigosertib may effectively treat certain cancers. In studies involving other cancer types, most patients tolerated it well, experiencing no severe side effects. Common side effects included mild digestive issues and tiredness.

Pembrolizumab, also known as Keytruda, has received FDA approval for treating various cancers. It is usually well-tolerated, though some patients have experienced immune-related side effects affecting the skin, liver, or lungs, which are generally manageable with treatment.

Researchers are examining the combination of rigosertib and pembrolizumab to determine its potential benefits for melanoma patients, particularly those unresponsive to other treatments. Although this combination remains under investigation, both drugs have demonstrated safety when used separately. This suggests they might be safe together, but ongoing studies will provide clearer answers.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Rigosertib with Pembrolizumab for skin cancer because this duo targets the disease in a new way. Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells, while Rigosertib disrupts the cancer cells' ability to divide and multiply. This combination could enhance effectiveness beyond current options, which typically involve surgery, radiation, or single-agent immunotherapies. By attacking the cancer on multiple fronts, this approach hopes to improve outcomes for patients with skin cancer.

What evidence suggests that rigosertib plus pembrolizumab might be an effective treatment for unresectable metastatic melanoma?

Studies have shown that combining rigosertib with pembrolizumab might effectively treat melanoma that cannot be removed or has spread. Research suggests this combination could significantly improve survival rates in patients with high-risk melanoma. In this trial, participants will receive both rigosertib and pembrolizumab. Pembrolizumab alone has produced positive results in about 34% of patients with metastatic melanoma, and its effects might strengthen when combined with rigosertib. Rigosertib blocks certain proteins that aid cancer cell growth and might enhance the effectiveness of immunotherapy. The goal of combining these treatments is to increase the chances of stopping the cancer from growing and spreading.16789

Who Is on the Research Team?

DJ

Douglas Johnson, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree to use contraception and not donate sperm for 96 days after my last treatment dose.
I am fully active or can carry out light work.
I am 18 or older with a confirmed diagnosis of advanced skin cancer that cannot be surgically removed.
See 7 more

Exclusion Criteria

History of severe hypersensitivity to study drugs or their excipients
I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.
I have had cancer treatment or radiation within the set time limits.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive rigosertib orally and pembrolizumab intravenously. Imaging and blood samples are collected.

Up to 3 years
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and overall survival.

Up to 30 days after last dose
Follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Rigosertib

Trial Overview

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.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

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

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials
221
Recruited
64,400+

Citations

Study Details | NCT05764395 | Rigosertib Plus ...

Giving rigosertib in combination with pembrolizumab may be more effective in treating patients with unresectable metastatic melanoma that has not responded to ...

Combination therapy could slash melanoma mortality risk

The combination therapy also demonstrated sustained improvement in the primary endpoint of recurrence-free survival for high-risk melanoma ...

Pembrolizumab Monotherapy for Recurrent or Metastatic ...

Objective response rate was 34.3% (95% CI, 25.3% to 44.2%; 4 complete responses, 32 partial responses), and disease control rate was 52.4% (95% CI, 42.4% to ...

Cancer Vaccine Combo a 'Potential Major Breakthrough' in ...

Additional findings showed that the 12-month relapse-free survival rate was 83.4% with the combination and 77.1% with single-agent Keytruda.

Immunotherapy drug shows long-lasting response in ...

UCLA researchers have found that the immunotherapy drug pembrolizumab produces positive responses that are long-lasting and with fewer side effects than ...

Rigosertib Plus Pembrolizumab in Treating Patients With ...

"A Phase 2 trial of rigosertib combined with Merck's anti-PD-1 therapy KEYTRYDA® (pembrolizumab) in checkpoint inhibitor refractory melanoma recently opened for ...

Efficacy and safety of rigosertib in patients with recessive ...

The ability of rigosertib to inhibit the growth of cancer cells correlates with PLK1 expression in hepatocellular17 and retinoblastoma cancers,18 and was the ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40439508/

Efficacy and safety of rigosertib in patients with recessive ...

Conclusions: These data identify rigosertib as a promising drug therapy for patients with RDEB-SCC where there is a substantial unmet need, ...

KEYNOTE-629: Selected Safety Data and Adverse Reactions

Learn about immune-mediated adverse reactions, their management, and safety data from the KEYNOTE-629 clinical trial for KEYTRUDA® (pembrolizumab).