Melanoma, Stage IIPhase 1DahliaNCT06551064
Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients
A Phase 1 study testing FYB206 and Keytruda in people with Melanoma, Stage II and Melanoma Stage III, run by Formycon AG at 17 sites in 11 countries.
Trial summary
Melanoma is a kind of skin cancer that starts in the melanocytes. Melanocytes are cells that make the pigment that gives skin its colour. 'Resected' means the melanoma has been completely removed with surgery. Pembrolizumab is an anti-cancer therapy that works with the immune system to fight cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Stage II, Melanoma Stage III
- What is being tested?
- FYB206 and Keytruda
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 17 sitesin 11 countries
- Study dates
- 1 Jul 2024to 7 Jul 2026
- Phase
- Phase 1
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
- Patients with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma (as classified by the American Joint Committee on Cancer [AJCC]'s Cancer Staging Manual, 8th Edition) who have undergone complete resection within 12 weeks before randomization. No evidence of past or current satellites or in-transit metastases.
- Disease status for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) and/or magnetic resonance imaging (MRI) with neck CT and/or MRI (for head and neck primaries) and must have completed a clinical examination after the informed consent form has been signed and before enrollment.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Caucasian adult patients ≥18 years of age on the day of signing the informed consent.
Who cannot join
- History of radiation therapy for melanoma before trial entry. Post-lymph node dissection radiotherapy is allowed; however, this should be completed at least 7 days before treatment starts.
- Uveal or ocular melanoma.
- Diagnosis of immunodeficiency or receiving long-term systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy ≤7 days before the first dose of IMP.
- Received prior therapy with an anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) monoclonal antibody (eg, ipilimumab), anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or agent directed to another stimulatory or co-inhibitory T-cell receptor.
- Received prior systemic anticancer therapy for melanoma.
Trial locations and contacts
17 sites in 11 countries.
17 sites in 11 countries
Georgia3 sites
Formycon Investigative Site
Batumi
Formycon Investigative Site
Kutaisi
Formycon Investigative Site
Tbilisi
Serbia3 sites
Formycon Investigative Site
Belgrade
Formycon Investigative Site
Kragujevac
Formycon Investigative Site
Niš
Poland2 sites
Formycon Investigative Site
Krakow
Formycon Investigative Site
Lodz
Romania2 sites
Formycon Investigative Site
Bucharest
Formycon Investigative Site
Cluj-Napoca
Bosnia and Herzegovina1 site
Formycon Investigative Site
Sarajevo
About this study
Official title: A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of Adjuvant FYB206 (Keytruda Biosimilar Candidate) in Comparison With Keytruda (Pembrolizumab) to Demonstrate Pharmacokinetic Similarity in Patients With Completely Resected Stage IIB/IIC or Stage III Melanoma
Melanoma is a kind of skin cancer that starts in the melanocytes. Melanocytes are cells that make the pigment that gives skin its colour. 'Resected' means the melanoma has been completely removed with surgery.
Pembrolizumab is an anti-cancer therapy that works with the immune system to fight cancer cells. Some cancer cells develop a way to hide from the body's immune system and, thus, allow the cancer cells to spread and grow. Pembrolizumab helps the immune system recognize and kill these cancer cells that want to hide.
Read more
Pembrolizumab is a biologic drug (produced by living organisms) available in the market under the brand name Keytruda. Keytruda is approved globally for the treatment of a variety of cancers and as an addon or after therapy to primary cancer treatment like surgery. This helps prevent the cancer from returning, improving overall survival.
FYB206 is a proposed biosimilar to Keytruda. A biosimilar is not identical but very similar to its original biologic. Biosimilars are expected to have a similar effect and safety to the original biologic. To learn what happens to a drug once it is in the body is called pharmacokinetics (PK). PK for biosimilar drugs is expected to remain similar to the original biologic. This study is to show that PK of FYB206 is similar to the reference product Keytruda for patients with completely resected Stage IIB/IIC or Stage III melanoma.
- Conditions
- Melanoma, Stage II, Melanoma Stage III
- Being tested
- FYB206, Keytruda
- Keywords
- pembrolizumab, biosimilar, melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYB206Biological
FYB206 (Keytruda biosimilar candidate - test product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle
KeytrudaBiological
Keytruda (reference product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| FYB206 | Experimental | Not described Receives: Biological: FYB206 |
| Keytruda | Active comparator | Not described Receives: Biological: Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau,sd at Cycle 1
Area under the concentration curve for one dosing interval (tau=21 days) after a single (initial) dose (AUCtau,sd) of FYB206 and Keytruda (Cycle 1)
Measured: 21 days
AUCtau,sd at Cycle 6
Area under the concentration curve for one dosing interval (tau=21 days) at steady state (AUCtau,ss) of FYB206 and Keytruda (Cycle 6)
Measured: 126 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jul 2024
- Primary completion5 Dec 2025
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma, Stage IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Formycon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551064
- Sponsor's protocol ID
- FYB206-C1-01
- Other IDs
- 2023-509765-20-00, 2023
- Acronym
- Dahlia
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No