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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06190951




Registration number
NCT06190951
Ethics application status
Date submitted
9/11/2023
Date registered
5/01/2024

Titles & IDs
Public title
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
Scientific title
A Phase 2 and Phase 3 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma
Secondary ID [1] 0 0
2022-502825-17-00
Secondary ID [2] 0 0
R3767-ONC-2208
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pembrolizumab
Treatment: Drugs - fianlimab
Treatment: Drugs - cemiplimab
Treatment: Drugs - cemiplimab+fianlimab

Active comparator: cemiplimab - Phase 2 Randomized 1:1:1

Experimental: cemiplimab+fianlimab HD - Phase 2 fianlimab HD Randomized 1:1:1 Phase 3 fianlimab ((if HD chosen for phase 3) Randomized 1:1

Experimental: cemiplimab+fianlimab LD - Phase 2 fianlimab LD Randomized 1:1:1 Phase 3 fianlimab (if LD chosen for Phase 3) Randomized 1:1

Active comparator: pembrolizumab - Phase 3 Randomized 1:1


Treatment: Drugs: pembrolizumab
Administered intravenous (IV) every 3 weeks (Q3W) Phase 3 active comparator

Treatment: Drugs: fianlimab
Administered IV Q3W Phase 2

Treatment: Drugs: cemiplimab
Administered IV Q3W Phase 2 Active Comparator

Treatment: Drugs: cemiplimab+fianlimab
Administered IV Q3W Phase 3 Either fianlimab HD or fianlimab LD in combination with cemiplimab will be chosen for Phase 3
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological complete response (pCR) rate as assessed by local pathological review
Timepoint [1] 0 0
Up to 1 year
Primary outcome [2] 0 0
Event-free survival (EFS)
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [1] 0 0
pCR rate as assessed by Blinded Independent Pathological Review (BIPR)
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [2] 0 0
pCR rate as assessed by local pathological review
Timepoint [2] 0 0
Up to 1 year
Secondary outcome [3] 0 0
EFS
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Distant metastasis-free survival (DMFS)
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Major pathological response (MPR) as assessed by BIPR
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
MPR rate as assessed by local pathological review
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
ORR assessed by investigator per RECIST 1.1 criteria
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
ORR assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 criteria
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
Relapse-free survival (RFS)
Timepoint [10] 0 0
Up to 4 years
Secondary outcome [11] 0 0
Occurrence of treatment-emergent adverse events (TEAEs)
Timepoint [11] 0 0
90 days following last dose of study drug, approximately 4 years
Secondary outcome [12] 0 0
Occurrence of immune-mediated adverse events (imAEs)
Timepoint [12] 0 0
90 days following last dose of study drug, approximately 4 years
Secondary outcome [13] 0 0
Occurrence of serious adverse events (SAEs)
Timepoint [13] 0 0
90 days following last dose of study drug, approximately 4 years
Secondary outcome [14] 0 0
Occurrence of adverse events of special interest (AESIs)
Timepoint [14] 0 0
90 days following last dose of study drug, approximately 4 years
Secondary outcome [15] 0 0
Occurrence of TEAEs resulting in death
Timepoint [15] 0 0
90 days following last dose of study drug, approximately 4 years
Secondary outcome [16] 0 0
Occurrence of interruption or discontinuation of study drug(s) due to TEAE.
Timepoint [16] 0 0
90 days following last dose of study drug, approximately 4 years
Secondary outcome [17] 0 0
Occurrence of cancellation of surgery due to TEAE or delay to surgery
Timepoint [17] 0 0
90 days following last dose of study drug, approximately 4 years
Secondary outcome [18] 0 0
Occurrence of laboratory abnormalities
Timepoint [18] 0 0
90 days following last dose of study drug, approximately 4 years
Secondary outcome [19] 0 0
Concentrations of fianlimab in serum
Timepoint [19] 0 0
Up to 4 years
Secondary outcome [20] 0 0
Concentrations of cemiplimab in serum
Timepoint [20] 0 0
Up to 4 years
Secondary outcome [21] 0 0
Anti-drug antibodies (ADA) in serum to fianlimab
Timepoint [21] 0 0
Up to 4 years
Secondary outcome [22] 0 0
ADA in serum to cemiplimab
Timepoint [22] 0 0
Up to 4 years
Secondary outcome [23] 0 0
Change from baseline in disease-related symptoms per Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale
Timepoint [23] 0 0
Up to 4 years
Secondary outcome [24] 0 0
Change from baseline in functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QoL) C30 (EORTC QLQ-C30)
Timepoint [24] 0 0
Up to 4 years
Secondary outcome [25] 0 0
Change from baseline in global health status/QoL per EORTC QLQ-C30
Timepoint [25] 0 0
Up to 4 years
Secondary outcome [26] 0 0
Change from baseline in overall health state per European Quality of Life Dimension 5 (EQ-5D-5L)
Timepoint [26] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
Key

1. All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per American Joint Committee on Cancer (AJCC) 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable in order to be eligible as described in the protocol.
2. Patients with stage III melanoma must have clinically detectable disease that is confirmed as malignant on the pathology report. The pathology report must be reviewed, signed and dated by the investigator; this process will be confirmed during the interactive voice response system (IVRS) process as described in the protocol.
3. Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization.
4. All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging must include a computer tomography (CT) scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain magnetic resonance imaging (MRI) (or brain CT with contrast allowed if MRI is contraindicated).
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical conditions:

1. Primary uveal melanoma
2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
3. Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion.
4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to or results in chronic infection as described in the protocol.

Prior/concomitant therapy:
5. Use of immunosuppressive doses of corticosteroids (>=10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication as described in the protocol.
6. Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol.

Other comorbidities:
7. Participants with a history of myocarditis.
8. History or current evidence of significant (CTCAE grade =2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.

Note: Other protocol-defined inclusion/ exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/06/2033
Actual
Sample size
Target
520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Melanoma Institute of Australia - Wollstonecraft
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
France
State/province [16] 0 0
Ile De France
Country [17] 0 0
France
State/province [17] 0 0
Boulogne
Country [18] 0 0
Italy
State/province [18] 0 0
Ferrara
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Salamanca

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06190951