Clinical Stage III Cutaneous Melanoma AJCC v8Phase 2NCT05764395
Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors
A Phase 2 study testing Rigosertib, Pembrolizumab and Magnetic Resonance Imaging in people with Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This phase II clinical trial tests how well rigosertib plus pembrolizumab workings in treating patients with melanoma which cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic), and that has not responded to previous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma
- What is being tested?
- Rigosertib, Pembrolizumab and Magnetic Resonance Imaging
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 13 Mar 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma will be enrolled in this study.
- Male participants: A male participant must agree to use a contraception during the treatment period and for at least 6 days (140 hours) plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period.
- Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contractive guidance during the treatment period and for at least 6 days (140 hours) plus 120 days after the last treatment dose of study.
- Participants must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 inhibitor treatment progression is defined by meeting the following criteria:
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- For patients treated with anti-PD-1/L1 mAb in the unresectable/metastatic setting:
- Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
- Has demonstrated disease progression after anti-PD-1/L1 as defined by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST). The initial evidence of progressive disease (PD) is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression.
- Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
- For patients treated with anti-PD-1/L1 mAb in the adjuvant setting:
- Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
- Develops recurrent disease during active adjuvant treatment with anti-PD-1/L1 mAb, OR
- Develops recurrent disease within 6 weeks of last dose of anti-PD-1/L1 mAb.
- Progressive disease is determined according to iRECIST (ie, progression by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1 on first imaging, confirmed with repeat imaging performed at least 4 weeks later). Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression OR
- The determination of clinical progression is made by the investigator.
- Participants whose disease harbors BRAF V600 mutation must have been exposed to BRAF-targeted therapy, with BRAF-targeted treatment discontinued for either progressive disease or intolerable toxicity.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Have measurable disease based on iRECIST. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Have provided archival tumor tissue sample or newly obtained (within 3 months of enrollment) core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- White blood cell (WBC) >= 3,000/uL. (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- Absolute neutrophil count (ANC) >= 1,500/uL. (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- Platelets >= 75,000/uL. (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L. (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- Criterion must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
- Serum creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance >= 30 mL/min for subject with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]). (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- Serum total bilirubin =< 1.5 X ULN OR =< 3.0 mg/dL for patients with Gilbert syndrome. (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN for subjects without liver metastases OR =< 5 X ULN for subjects with liver metastases. (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- International normalized ration (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants. (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
- Urinalysis negative for hematuria with negative blood and 0 red blood cells (RBCs) (Laboratory values must be collected within 10 days prior to the start of study intervention [ie, first dose of study treatment]).
Who cannot join
- Has a diagnosis of primary uveal or mucosal melanoma.
- A WOCBP who has a positive urine pregnancy test within 72 hours of the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication. Pregnancy testing will be obtained every three months while on study treatment; patients will be withdrawn from the study if pregnancy occurs.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (for immunotherapeutic agents) or within 2 weeks (for targeted therapeutics) prior to the first dose of study drug. If a subject has experienced adverse events (AE) from prior treatment, he/she must have recovered from all AEs to < grade 1 or baseline. Patients with < grade 2 neuropathy may be eligible. Patients with endocrine-related AEs < 2 requiring treatment or physiologic steroid replacement may be eligible.
- Has received prior radiotherapy within 2 weeks of the first dose of study drug. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
- If participant has had recent major surgery, the participant must has recovered adequately from the procedure and/or any complications from the surgery prior to the first dose of study drug.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
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- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with non-melanoma skin cancer (eg, basal cell carcinoma of the skin, squamous cell carcinoma of the skin) or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Subjects with untreated active central nervous system (CNS) metastases, active brain metastases or leptomeningeal metastatic foci. For the subjects with brain metastases, if they have received treatment and have no evidence of progressive disease on magnetic resonance imaging (MRI) at least 4 weeks after completion of the treatment and within 30 days prior to the first dose, they are eligible to participate in the study.
- Has a history of severe hypersensitivity (>= grade 3), specifically infusion reaction or anaphylaxis to pembrolizumab and/or any of its excipients.
- Has a history of severe hypersensitivity (>= grade 3 reactions including wheezing, rash, or hypotension) to rigosertib and/or any of its excipients (including polyethylene glycol), or anaphylaxis.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection. Note: no testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
- Has a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: A Phase II Study to Evaluate the Safety and Efficacy of Rigosertib (ON 01910) Plus Pembrolizumab in Patients With Metastatic Melanoma Refractory to Immune Checkpoint Blockade
This phase II clinical trial tests how well rigosertib plus pembrolizumab workings in treating patients with melanoma which cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic), and that has not responded to previous treatment with PD-1 or PD-L1 inhibitors (refractory). Rigosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may change the immune system to make immunotherapy more effective. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving rigosertib in combination with pembrolizumab may be more effective in treating patients with unresectable metastatic melanoma that has not responded to previous treatment with PD-1 or PD-L1 inhibitors than giving either drug alone.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of rigosertib plus pembrolizumab in patients with metastatic melanoma who are refractory to treatment with a PD-1 inhibitor.
SECONDARY OBJECTIVES:
- To evaluate progression-free survival (PFS) in patients with PD-1 inhibitor refractory metastatic melanoma receiving rigosertib plus pembrolizumab.
II. To evaluate safety, tolerability and adverse event profile of rigosertib plus pembrolizumab in patients with PD-1 inhibitor refractory metastatic melanoma.
III. To evaluate overall survival (OS) in patients with PD-1 inhibitor refractory metastatic melanoma receiving rigosertib plus pembrolizumab.
EXPLORATORY OBJECTIVE:
- To evaluate change in tumor-infiltrating lymphocytes (TILs) upon treatment with rigosertib plus pembrolizumab in patients with metastatic melanoma that is refractory to PD-1 inhibitor.
OUTLINE:
Patients receive rigosertib orally (PO) plus pembrolizumab intravenously (IV) throughout the study. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection at screening and on study, and may also undergo tissue biopsy at screening and on study.
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Refractory Melanoma, Unresectable Melanoma
- Being tested
- Rigosertib, Pembrolizumab, Magnetic Resonance Imaging, Biospecimen Collection, Biopsy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RigosertibDrug
Given by mouth
PembrolizumabBiological
Given by IV
Magnetic Resonance ImagingProcedure or surgery
Undergo MRI
Biospecimen CollectionProcedure or surgery
Undergo blood sample collection
BiopsyProcedure or surgery
Undergo tissue biopsy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Rigosertib, pembrolizumab) | Experimental | 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. Receives: Drug: Rigosertib; Biological: Pembrolizumab; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall response rate will be assessed as defined by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST 1.1). Overall all response is patients with complete response (CR) plus those with partial response (PR): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Measured: Tumor imaging performed every 8 weeks through Week 24 and every 12 weeks thereafter until documented disease progression, up to two years
Secondary outcomes (4)
Median Progression Free Survival (PFS)
Progression will be assessed as defined by Immune-Modified Response Evaluation Criteria in Solid Tumors criteria (iRECIST 1.1). Median PFS will be assessed using the Kaplan-Meier method and reported with 95% confidence intervals. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Disease progression was assessed every 8 weeks through Week 24 and every 12 weeks thereafter, up to 2 years
Progression Free Survival (PFS) at One Year
Progression will be assessed as defined by Immune-Modified Response Evaluation Criteria in Solid Tumors criteria (iRECIST 1.1). PFS at one year will be assessed using the Kaplan-Meier method and reported with 95% confidence intervals. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Disease progression was assessed every 8 weeks through Week 24 and every 12 weeks thereafter, up to 1 year
Incidence of Adverse Events Related to Treatment
Will be assessed using the National Cancer Institutes Common Terminology for Adverse Events, version 5.0. Highest grade reported per toxicity per patient.
Measured: Adverse events were collected during treatment and through 30 days after the last dose of study intervention, up to 2 years
Overall Survival
Will be assessed using the Kaplan-Meier method. Patients alive at last follow-up will be censored. Median survival and its 95% confidence interval will be estimated and reported.
Measured: Time interval between the patient's death (or lost to follow-up date) and treatment start date, Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start9 May 2023
- Primary completion15 Jul 2025
- Study completion13 Mar 2026
Why it stopped: Drug unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clinical Stage III Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Johnson, Vanderbilt-Ingram Cancer Center
- Investigators
- Douglas Johnson, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764395
- Sponsor's protocol ID
- VICCMEL2218
- Other IDs
- NCI-2023-01369
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2023
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety and Efficacy of Rigosertib (ON 01910) Plus Pembrolizumab in Patients With Metastatic Melanoma Refractory to Immune Checkpoint Blockade
- ClinicalTrials.gov ID
- NCT05764395
- Acronym / sponsor ID
- VICCMEL2218
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Refractory Melanoma, Unresectable Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug unavailable
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 16 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical trial tests how well rigosertib plus pembrolizumab workings in treating patients with melanoma which cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic), and that has not responded to previous treatment with PD-1 or PD-L1 inhibitors (refractory). Rigosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may change the immune system to make immunotherapy more effective. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving rigosertib in combination with pembrolizumab may be more effective in treating patients with unresectable metastatic melanoma that has not responded to previous treatment with PD-1 or PD-L1 inhibitors than giving either drug alone.
Detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of rigosertib plus pembrolizumab in patients with metastatic melanoma who are refractory to treatment with a PD-1 inhibitor.
SECONDARY OBJECTIVES:
- To evaluate progression-free survival (PFS) in patients with PD-1 inhibitor refractory metastatic melanoma receiving rigosertib plus pembrolizumab.
II. To evaluate safety, tolerability and adverse event profile of rigosertib plus pembrolizumab in patients with PD-1 inhibitor refractory metastatic melanoma.
III. To evaluate overall survival (OS) in patients with PD-1 inhibitor refractory metastatic melanoma receiving rigosertib plus pembrolizumab.
EXPLORATORY OBJECTIVE:
- To evaluate change in tumor-infiltrating lymphocytes (TILs) upon treatment with rigosertib plus pembrolizumab in patients with metastatic melanoma that is refractory to PD-1 inhibitor.
OUTLINE:
Patients receive rigosertib orally (PO) plus pembrolizumab intravenously (IV) throughout the study. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection at screening and on study, and may also undergo tissue biopsy at screening and on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Rigosertib, pembrolizumab) | Experimental | Drug: Rigosertib, Biological: Pembrolizumab, Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen Collection, Procedure: BiopsyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma will be enrolled in this study.
- Participants must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 inhibitor treatment progression is defined by meeting the following criteria:
- Participants whose disease harbors BRAF V600 mutation must have been exposed to BRAF-targeted therapy, with BRAF-targeted treatment discontinued for either progressive disease or intolerable toxicity.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Have measurable disease based on iRECIST. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Key exclusion criteria (21 listed)
- Has a diagnosis of primary uveal or mucosal melanoma.
- A WOCBP who has a positive urine pregnancy test within 72 hours of the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication. Pregnancy testing will be obtained every three months while on study treatment; patients will be withdrawn from the study if pregnancy occurs.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (for immunotherapeutic agents) or within 2 weeks (for targeted therapeutics) prior to the first dose of study drug. If a subject has experienced adverse events (AE) from prior treatment, he/she must have recovered from all AEs to < grade 1 or baseline. Patients with < grade 2 neuropathy may be eligible. Patients with endocrine-related AEs < 2 requiring treatment or physiologic steroid replacement may be eligible.
- Has received prior radiotherapy within 2 weeks of the first dose of study drug. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
- If participant has had recent major surgery, the participant must has recovered adequately from the procedure and/or any complications from the surgery prior to the first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RigosertibGiven by mouth | Drug | Treatment (Rigosertib, pembrolizumab) |
| PembrolizumabGiven by IV | Biological | Treatment (Rigosertib, pembrolizumab) |
| Magnetic Resonance ImagingUndergo MRI | Procedure or surgery | Treatment (Rigosertib, pembrolizumab) |
| Biospecimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (Rigosertib, pembrolizumab) |
| BiopsyUndergo tissue biopsy | Procedure or surgery | Treatment (Rigosertib, pembrolizumab) |
Primary outcome
Overall Response Rate
Time frame: Tumor imaging performed every 8 weeks through Week 24 and every 12 weeks thereafter until documented disease progression, up to two years
Overall response rate will be assessed as defined by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST 1.1). Overall all response is patients with complete response (CR) plus those with partial response (PR): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
4 secondary outcomes
Median Progression Free Survival (PFS)
Time frame: Disease progression was assessed every 8 weeks through Week 24 and every 12 weeks thereafter, up to 2 years
Progression Free Survival (PFS) at One Year
Time frame: Disease progression was assessed every 8 weeks through Week 24 and every 12 weeks thereafter, up to 1 year
Incidence of Adverse Events Related to Treatment
Time frame: Adverse events were collected during treatment and through 30 days after the last dose of study intervention, up to 2 years
Overall Survival
Time frame: Time interval between the patient's death (or lost to follow-up date) and treatment start date, Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Johnson, MD principal investigator
Vanderbilt University/Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rigosertib, Pembrolizumab and Magnetic Resonance Imaging in people with Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Tumor imaging performed every 8 weeks through Week 24 and every 12 weeks thereafter until documented disease progression, up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.