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New treatment option for Merkel Cell Carcinoma
Official title Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
ClinicalTrials.gov ID: NCT06151236
What this study is testing
What is Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination?
Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination is an investigational medicine, being studied as a potential treatment for merkel cell carcinoma.
Also referred to as Opdualag.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥ 18 years
- Written consent
- Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease
- In-transit metastases are permitted if they are completely resectable
- Measurable disease according to RECIST 1.1 criteria
You likely can't join if
- Clinical, radiographic or pathological evidence of distant metastases
- Contraindication to nivolumab and / or relatlimab
- Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any...
- Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy
- A diagnosis of immunodeficiency or chronic steroid therapy \>10 mg OD prednisone or equivalent
- Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study.
See the full eligibility criteria
- Aged ≥ 18 years
- Written consent
- Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease
- In-transit metastases are permitted if they are completely resectable
- Measurable disease according to RECIST 1.1 criteria
- Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy
- At least one of either, archival tissue from a primary or nodal MCC lesion (if applicable) for the current diagnosis and/or a newly obtained core biopsy of a lesion which has not been previously irradiated.
- ECOG 0-1
- Adequate organ function on blood pathology
- Life expectancy \>12 months
- Female patients to use effective contraception during study treatment and for 5 months after last dose.
- Clinical, radiographic or pathological evidence of distant metastases
- Contraindication to nivolumab and / or relatlimab
- Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment
- Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy
- A diagnosis of immunodeficiency or chronic steroid therapy \>10 mg OD prednisone or equivalent
- Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study.
- Uncontrolled cardiovascular disease or history of myocarditis
- Has had an allogenic tissue/solid organ transplant
- Troponin T (TnT) or I (TnI) \>2 × institutional ULN
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease
- Has an active infection requiring systemic therapy
- Active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Known HIV
- Pregnant or breast feeding females
- Concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule
The study team makes the final eligibility decision.
Where it's taking place
- Wollstonecraft, New South Wales, Australia
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wollstonecraft, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.