SWE-NEO: Swedish NeoAdjuvant Trial Comparing Anti-PD-1 Monotherapy to Combined Anti-CTLA-4/Anti-PD-1 Blockade in Resectable Stage III Melanoma

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

At present two studies (SWOG S1801 and NADINA) have demonstrated superiority when using neoadjuvant treatment compared to adjuvant treatment only, but no studies have compared PD-1 monotherapy (SWOG 1801 regimen) to the PD-1/CTLA-4 combination (NADINA regimen) therapy. The SWE-NEO study aims to compare these two regimens, where the PD-1/CTLA-4 combination is potentially more effective, but also associated with more side effects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must be at least 18 years of age.

• Can provide a signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol.

• World Health Organization (WHO) Performance Status 0 or 1.

• Patients must have

∙ Histologically or cytologically confirmed Stage III melanoma. In the case of in-transit metastases (with or without lymph node metastases)' ≤3 resectable in-transit metastases are allowed.

‣ Patients with cutaneous, acral, or unknown primary melanomas are eligible for enrollment.

‣ Resectable tumors are defined as having no significant vascular, neural or bony involvement. Only patients where a complete surgical resection with tumor-free margins can safely be achieved are defined as resectable.

• 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 a highly effective 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. Highly effective methods of contraception include one or more of the following:

∙ male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject;

‣ hormonal (oral, intravaginal, transdermal, implantable or injectable)

‣ an intrauterine hormone-releasing system (IUS)

‣ an intrauterine device (IUD) with a documented failure rate of \< 1%.

• 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. A unique female sexual partner must postmenopausal, permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception.

• No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.

• No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1.

⁃ No prior targeted therapy targeting BRAF and/or MEK.

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Skane University Hospital
NOT_YET_RECRUITING
Lund
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Hildur Helgadottir, MD, PhD
hildur.helgadottir@regionstockholm.se
+46 8-123 734 15
Backup
Roger Olofsson Bagge, Professor
roger.olofsson.bagge@gu.se
+46313421000
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2032-04-15
Participants
Target number of participants: 128
Treatments
Active_comparator: PD-1 inhibitor monotherapy
Monotherapy with Nivolumab
Experimental: PD-1/CTLA-4 inhibitor combination therapy
Combination therapy with Nivolumab and Ipilimumab
Related Therapeutic Areas
Sponsors
Leads: Hildur Helgadottir

This content was sourced from clinicaltrials.gov

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