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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT05764395
Phase
PHASE2
Status
Terminated

Conditions

  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Melanoma
  • Refractory Melanoma
  • Unresectable Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rigosertib — DRUG
    Given by mouth
  • Pembrolizumab — BIOLOGICAL
    Given by IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Biopsy — PROCEDURE
    Undergo tissue biopsy

Study Details

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.

Key Dates

First listed
Mar 10, 2023
Start date
May 9, 2023
Status verified
Aug 2026
Primary completion
Jul 15, 2025
Completion
Mar 13, 2026

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Rigosertib, pembrolizumab)
    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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-

Related coverage on Hipa.ai

Find similar trials in Nashville, TN

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Melanoma trialsOncology trialsSkin cancer trialsDermatology trials
By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

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