Uptake and biodistribution of 89Zirconium-labeled ipilimumab in ipilimumab treated patients with metastatic melanoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Amsterdam UMC

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Oct 2024 → ongoing

Decision date (initial)

2024-10-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516547-11-00

EudraCT number

2012-003616-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy

To assess uptake (visual = uptake above local background, and quantitative, expressed as SUVmean and SUVpeak) of 89Zr-ipilimumab in tumor lesions as well as its biodistribution in ipilimumab/nivolumab combination treated patients.

Conditions and MedDRA coding

skincancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Advanced/metastatic melanoma
2. Scheduled for treatment with combination treatment of nivolumab and ipilimumab.
3. Age ≥ 18 years.
4. Histological or cytological documentation of cancer is required.
5. WHO Performance Status of 0 or 1.
6. At least 1 measurable lesion.
7. Signed informed consent must be obtained prior to any study procedures.
8. Patients must be able to adhere to the study appointments and other protocol requirements.

Exclusion criteria 7

1. Previous exposure to ipilimumab or nivolumab.
2. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g. cervical cap, condom and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.
3. Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks after starting the study drug.
4. Radiotherapy of target lesions during study or within 4 weeks after starting the study drug. Palliative radiotherapy will be allowed.
5. Major surgery within 28 days of start of study drug.
6. Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
7. Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The detection of 89Zr-ipilimumab in tumor lesions. Tumor lesions will be defined using a diagnostic CT-scan or MRI. The short axis diameter of a measurable tumor lesion is ≥1 cm. The five largest lesions will be used for evaluation.

Secondary endpoints 9

1. Response after starting therapy with ipilimumab/nivolumab combination therapy at 12 and 24 weeks and every 12 weeks thereafter
2. Overall survival
3. The detection (visual and quantitative) of 89Zr-ipilimumab in normal tissue
4. Adverse events using Common Terminology Criteria Adverse Events, version 4.0 (CTCAE 4.0) & Correlation between side effects of ipilimumab/nivolumab combination therapy and uptake of 89Zr-ipilimumab in normal tissue
5. CTLA-4+CD4+ expression of PBMCs (before start of ipilimumab and during treatment)
6. Correlation between CTLA-4+CD4+ expression of PBMCs and uptake of 89Zripilimumab in tissues.
7. Pharmacokinetics & dosimetry of 89Zr-ipilimumab
8. The SUV in tumor lesions will be compared to the SUV in blood. Specific uptake of ipilimumab in tumor lesions is defined as SUVtumor/SUVblood>1.
9. CTLA-4 expression on tumor infiltrating lymphocytes

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Amsterdam UMC

Sponsor organisation

Stichting Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Stichting Amsterdam UMC

Contact name

Viviana Groutars

Public contact point

Organisation

Stichting Amsterdam UMC

Contact name

Viviana Groutars

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications