A Phase 3 interventional study of PHP and IPI1/NIVO3 in Uveal Melanoma and Liver Metastases, sponsored by Vastra Gotaland Region. Recruiting at 6 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Vastra Gotaland Region · Phase 3, Interventional, and Treatment
Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumor, metastatic disease will develop in approximately 35%-50% of the patients within 10 years. The liver is the most common site for metastases, and about 50% of the patients will have isolated liver metastases. These metastases are generally refractory to systemic chemotherapy and the median survival for patients with liver metastases is about 6 months. Regardless of treatment, the mortality rate is approximately 90% at 2 years with only about 1% of the patients surviving more than 5 years.
The primary objective with this study is to evaluate progression-free survival in patients with uveal melanoma liver metastases randomized to either percutaneous hepatic perfusion (PHP) in combination with ipilimumab and nivolumab or ipilimumab and nivolumab only. Secondary objectives include further efficacy and safety analysis, as well as biomarker discovery.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 40 is close to the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated with 4 cycles of intravenous (i.v.) infusion with ipilimumab 3mg/kg and nivolumab 1mg/kg q3w followed by continued i.v. nivolumab 480mg q4w up to 1 year
Drug: IPI3/NIVO1
Patients will be treated with two cycles of PHP (CHEMOSAT® Hepatic Delivery System for Melphalan) six weeks apart, followed by two cycles of i.v. ipilimumab 1mg/kg and nivolumab 3mg/kg q3w, followed by continued i.v. nivolumab 480mg q4w up to 1 year
Device: PHP · Drug: IPI1/NIVO3
Patients will be treated with 2 cycles of PHP (CHEMOSAT® Hepatic Delivery System for Melphalan) six weeks apart
Also known as: CHEMOSAT® Hepatic Delivery System for Melphalan
Patients will be treated with 2 cycles of i.v. ipilimumab 1mg/kg and nivolumab 3mg/kg q3w, followed by continued i.v. nivolumab 480mg q4w up to 1 year.
Also known as: Ipilimumab 1 mg/kg, Nivolumab 3 mg/kg
Patients will be treated with 4 cycles of intravenous (i.v.) infusion with ipilimumab 3mg/kg and nivolumab 1mg/kg q3w followed by continued i.v. nivolumab 480mg q4w up to 1 year.
Also known as: Ipilimumab 3 mg/kg, Nivolumab 1 mg/kg
Progression-free survival (PFS)
The primary objective is to evaluate progression-free survival in patients with uveal melanoma hepatic dominant metastases randomized to either percutaneous hepatic perfusion (PHP) in combination with IPI1/NIVO3 or the combination of IPI3/NIVO1 only
Time frame: 24 month
Adverse events
Frequency and severity of AEs and SAEs graded according to the NCI CTCAE v5.0.
Time frame: 24 month
Overall response rate
Evaluation of objective response rate (ORR), defined as the percentage of patients achieving a confirmed complete or partial response, as defined by RECIST version 1.1 criteria
Time frame: 24 month
Clinical benefit rate
Evaluation of clinical benefit rate (CBR), defined as the percentage of patients achieving confirmed SD or any confirmed CR or PR. As defined by RECIST version 1.1 criteria
Time frame: 24 month
Hepatic progression-free survival
Evaluation of hepatic PFS (hPFS), defined as the time-to-event defined by the first documented disease progression in the liver or death due to any cause, whichever occurs first, from randomization. hPFS will be determined based on tumor assessment using RECIST version 1.1 criteria.
Time frame: 24 month
Overall survival
Evaluation of overall survival (OS), defined as the time from randomization to death from any cause.
Time frame: 24 month
Melanoma-specific survival
Evaluation of melanoma-specific survival (MSS), defined as the time from randomization to death from uveal melanoma
Time frame: 24 month
Duration of response
Evaluation of duration of response (DOR), defined as the time to first documented progression or death due to underlying cancer from the first document CR or PR
Time frame: 24 month
Quality of Life as assessed by FACT-G
Evaluation of QoL using The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, where overall scores for FACT-G and the sub scales physical (PWB), social (SWB), emotional (EWB), and functional well-being (FWB) will be reported.
Time frame: 24 month
Quality of Life as assessed by EQ-5D-5L
Evaluation of QoL using EQ-5D-5L where EQ-VAS (0-100) will be reported
Time frame: 24 month
ctDNA zero-conversion rate at 24 weeks
ctDNA zero-conversion rate at 24 weeks, defined as the percentage of patients that at 24 weeks have no measurable ctDNA levels compared to baseline sample
Time frame: 24 weeks
Biomarker discovery
Predictive and prognostic biomarker discovery
Time frame: 24 month
Plan to share: No
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Vastra Gotaland Region