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SWE-NEO: Swedish NeoAdjuvant Trial Comparing anti-PD-1 Monotherapy to Combined anti-CTLA-4/anti-PD-1 blockade in Resectable Stage III Melanoma
EU CTIS ID: 2024-519593-39-00
What this study is testing
To study event-free survival (EFS) in patients with resectable stage III melanoma, receiving two different neoadjuvant immune checkpoint inhibitor (ICI) regimens, combined anti-CTLA-4/anti-PD-1 blockade or anti-PD-1 monotherapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be at least 18 years of age.
- No prior targeted therapy targeting BRAF and/or MEK.
- 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 a. 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. b. Patients with cutaneous, acral, or unknown primary melanomas are eligible for enrollment. c. 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.
You likely can't join if
- Unresectable melanoma
- Uveal/ocular or mucosal melanoma
- Any serious or uncontrolled medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy (including operation), or interfere with the interpretation of study results
- Subjects with 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.
- Women who are pregnant or breastfeeding.
- Any condition that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
See the full eligibility criteria
Who can join
- Participants must be at least 18 years of age.
- No prior targeted therapy targeting BRAF and/or MEK.
- 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 a. 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. b. Patients with cutaneous, acral, or unknown primary melanomas are eligible for enrollment. c. 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: a. 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; b. hormonal (oral, intravaginal, transdermal, implantable or injectable) c. an intrauterine hormone-releasing system (IUS) d. 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.
What rules you out
- Unresectable melanoma
- Uveal/ocular or mucosal melanoma
- Any serious or uncontrolled medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy (including operation), or interfere with the interpretation of study results
- Subjects with 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.
- Women who are pregnant or breastfeeding.
- Any condition that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.