Rigosertib + Pembrolizumab for Skin Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rigosertib orally and pembrolizumab intravenously. Imaging and blood samples are collected.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and overall survival.
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
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.
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
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 ...
2.
ddw-online.com
ddw-online.com/combination-therapy-could-slash-melanoma-mortality-risk-40051-202601/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 ...
4.
curetoday.com
curetoday.com/view/cancer-vaccine-combo-a-potential-major-breakthrough-in-skin-cancerCancer 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.
5.
uclahealth.org
uclahealth.org/news/release/immunotherapy-drug-shows-long-lasting-response-in-advanced-melanomaImmunotherapy 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 ...
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).
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