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Uveal MelanomaPhase 3SCANDIUM-IIINCT06519266

PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases

A Phase 3 study testing PHP, IPI1/NIVO3 and IPI3/NIVO1 in people with Uveal Melanoma and Liver Metastases, run by Vastra Gotaland Region at 6 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Uveal Melanoma, Liver Metastases
What is being tested?
PHP, IPI1/NIVO3 and IPI3/NIVO1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
6 sitesSweden
Study dates
10 Jun 2024to 31 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Patient is ≥18 years.
  • Signed informed consent.
  • ECOG performance status of 0 or 1.
  • Histologically or cytologically confirmed liver metastasis of uveal melanoma.
  • Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver.
  • No previous treatment for uveal melanoma metastases, except patients that have confirmed progression on tebentafusp, or after surgical resection or ablative treatments (e.g., radiofrequency ablation or stereotactic body radiation therapy).
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  • Patient deemed suitable for percutaneous hepatic perfusion.
  • Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Who cannot join

  • Life expectancy of less than 6 months.
  • More than 50% of the liver volume replaced by tumor as measured by CT.
  • Extrahepatic disease as measured by CT of thorax and abdomen.
  • History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes the use of general anesthesia.
  • History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.
  • Patients who are unable to undergo general anesthesia for any reason.
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  • Reduced renal function defined as S-Creatinine >=1.5xULN or Creatinine Clearance < 40 mL/min, calculated using the Cockroft and Gault formula.
  • Reduced hepatic function (defined as AST, ALT, bilirubin>2.5*ULN and PK-INR>1.5) or medical history of liver cirrhosis (Child-Pugh Class B or C) or evidence of portal hypertension by history, endoscopy or radiology.
  • Hemoglobin <90 g/L or platelets <100x109/L or neutrophils <1.5x109/L.
  • Use of live vaccines four weeks before or after the last study treatment.
  • History of severe reactions to monoclonal antibodies, melphalan, heparin or iodine contrast.
  • Known human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
  • Active autoimmune disease or a documented history of autoimmune disease requiring systemic immunomodulatory treatment. Diabetes, rheumatoid arthritis, psoriasis, atopic dermatitis and hypothyroidism are excepted.
  • A condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
  • Has a known additional malignancy that is progressing or requires active treatment.
  • Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug.
  • A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate in the opinion of the treating investigator.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Roger Olofsson Bagge, Professor contact

+46313421000

roger.olofsson.bagge@vgregion.se

6 sites in 1 country

Sweden6 sites, 6 recruiting

  • Sahlgrenska University Hospital

    Gothenburg

    Lars Ny, MD, PhD

    Lars Ny, MD, PhD

    Recruiting

  • Linköping University Hospital

    Linköping

    Sander Ellegård, MD, PhD

    Sander Ellegård, MD, PhD

    Not yet recruiting

  • Skåne University Hospital

    Lund

    Ana Carneiro, MD, PhD

    Ana Carneiro, MD, PhD

    Not yet recruiting

  • Karolinska University Hospital,

    Stockholm

    Hildur Helgadottir, MD, PhD

    Hildur Helgadottir, MD, PhD

    Recruiting

  • Norrland University Hospital

    Umeå

    Sara Wirén, MD, PhD

    Sara Wirén, MD, PhD

    Not yet recruiting

  • Uppsala University Hospital

    Uppsala

    Gustav Ullenhag, MD, PhD

    Gustav Ullenhag, MD, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: A Phase III Randomized Controlled Multicentre Trial of Percutaneous Hepatic Perfusion in Combination With Ipilimumab and Nivolumab Compared to Ipilimumab and Nivolumab Only in Patients With Uveal Melanoma Liver Metastases

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.

Being tested
PHP, IPI1/NIVO3, IPI3/NIVO1
Keywords
Percutaneous Hepatic Perfusion, Immunotherapy, Uveal Melanoma, Liver metastases, SCANDIUM III trial
Medical subject headings
Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHPDevice

    Also called CHEMOSAT® Hepatic Delivery System for Melphalan

    Patients will be treated with 2 cycles of PHP (CHEMOSAT® Hepatic Delivery System for Melphalan) six weeks apart

  • IPI1/NIVO3Drug

    Also called Ipilimumab 1 mg/kg, Nivolumab 3 mg/kg

    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.

  • IPI3/NIVO1Drug

    Also called Ipilimumab 3 mg/kg, Nivolumab 1 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.

Study groups in NCT06519266
Study groupRoleWhat they receive
IPI3/NIVO1Active comparatorPatients 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
Receives: Drug: IPI3/NIVO1
PHP + IPI1/NIVO3ExperimentalPatients 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
Receives: Device: PHP; Drug: IPI1/NIVO3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 month

Secondary outcomes (9)

  1. Adverse events

    Frequency and severity of AEs and SAEs graded according to the NCI CTCAE v5.0.

    Measured: 24 month

  2. 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

    Measured: 24 month

  3. 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

    Measured: 24 month

  4. 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.

    Measured: 24 month

  5. Overall survival

    Evaluation of overall survival (OS), defined as the time from randomization to death from any cause.

    Measured: 24 month

  6. Melanoma-specific survival

    Evaluation of melanoma-specific survival (MSS), defined as the time from randomization to death from uveal melanoma

    Measured: 24 month

  7. 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

    Measured: 24 month

  8. 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.

    Measured: 24 month

  9. Quality of Life as assessed by EQ-5D-5L

    Evaluation of QoL using EQ-5D-5L where EQ-VAS (0-100) will be reported

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start10 Jun 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06519266
Sponsor's protocol ID
2023-508156-20-00
Other IDs
2023
Acronym
SCANDIUM-III
Status last verified
Nov 2024
First submitted
10 Jul 2024
Last updated
25 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PHP, IPI1/NIVO3 and IPI3/NIVO1 in people with Uveal Melanoma and Liver Metastases, run by Vastra Gotaland Region at 6 sites in Sweden.

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 10 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roger Olofsson Bagge, Professor (+46313421000, roger.olofsson.bagge@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06519266.

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 25 Nov 2024.

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