Actively Recruiting
PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases
Led by Vastra Gotaland Region · Updated on 2024-11-25
40
Participants Needed
6
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older.
- Signed informed consent is provided.
- ECOG performance status of 0 or 1.
- Histologically or cytologically confirmed liver metastasis of uveal melanoma.
- Measurable disease by CT per RECIST 1.1 with at least one target lesion in the liver.
- No previous treatment for uveal melanoma metastases except confirmed progression on tebentafusp or after surgery or ablative treatments.
- Patient suitable for percutaneous hepatic perfusion.
- Female patients of childbearing potential must have a negative pregnancy test within 72 hours before first treatment.
- Female patients of childbearing potential must agree to use adequate contraception during the study and for 150 days after last dose.
- Male patients of childbearing potential must agree to use adequate contraception during the study and for 150 days after last dose.
You will not qualify if you...
- Life expectancy less than 6 months.
- More than 50% of liver volume replaced by tumor.
- Extrahepatic disease detected by CT.
- History of congestive heart failure or active cardiac conditions preventing anesthesia.
- History or evidence of severe pulmonary disease preventing anesthesia.
- Inability to undergo general anesthesia for any reason.
- Reduced renal function (S-Creatinine 61.5xULN or Creatinine Clearance <40 mL/min).
- Reduced hepatic function or liver cirrhosis (Child-Pugh B or C) or portal hypertension.
- Hemoglobin <90 g/L, platelets <100x10^9/L, or neutrophils <1.5x10^9/L.
- Use of live vaccines within 4 weeks before or after last study treatment.
- History of severe reactions to monoclonal antibodies, melphalan, heparin, or iodine contrast.
- Known HIV, AIDS, hepatitis B or C infection.
- Active autoimmune disease requiring systemic immunomodulatory treatment (except diabetes, rheumatoid arthritis, psoriasis, atopic dermatitis, hypothyroidism).
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 14 days before study drug.
- Concurrent anti-cancer therapy or investigational drugs.
- Known additional malignancy that is progressing or requires active treatment.
- Pregnant, breastfeeding, or expecting to conceive or father children during the study period.
- Any other condition or abnormality that could affect study results or participation as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Linköping University Hospital
Linköping, Sweden
Not Yet Recruiting
3
Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
4
Karolinska University Hospital,
Stockholm, Sweden
Actively Recruiting
5
Norrland University Hospital
Umeå, Sweden
Not Yet Recruiting
6
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
R
Roger Olofsson Bagge, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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