A trial to see if the combination of fianlimab with cemiplimab works better than pembrolizumab for preventing or delaying melanoma from coming back after it has been removed with surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

7 Jul 2023 → ongoing

Decision date (initial)

2023-05-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Regeneron Pharmaceuticals Inc.

External identifiers

EU CT number

2022-501576-25-00

ClinicalTrials.gov

NCT05608291

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacokinetic, Efficacy, Safety

To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS)

Secondary objectives 6

1. To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage, IIB, IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumab
2. To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab
3. To characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older
4. To assess immunogenicity of fianlimab and against cemiplimab
5. To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by OS
6. To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults

Conditions and MedDRA coding

Melanoma

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition according to cutaneous melanoma staging criteria and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
2. Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
3. All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol

Exclusion criteria 6

1. Uveal melanoma
2. Any evidence of residual disease after surgery by imaging, pathology, or cytology
3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
5. Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
6. Adolescent patients (≥12 to <18 years old) with body weight <40 kg

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relapse free survival (RSF)

Secondary endpoints 22

1. Overall survival (OS)
2. Distant metastasis-free survival (DMFS)
3. Occurrence of treatment-emergent adverse events (TEAEs)
4. Occurrence of immune-mediated EAEs (im-EAEs)
5. Occurrence of serious adverse events (SAEs)
6. Occurrence of adverse events of special interest (AESIs)
7. Occurrence of TEAEs resulting in death
8. Occurrence of dose-limiting toxicity (DLT)
9. Occurrence of interruption or discontinuation of study drug(s) due to TEAE
10. Occurrence of laboratory abnormalities
11. Concentrations of fianlimab in serum over time
12. Concentrations of cemiplimab in serum over time
13. Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies
14. Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
15. Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
16. PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)
17. PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma
18. PRO for adults as determined by the Patient Global Impressions Scale (PGIS)
19. PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC)
20. Time to global health status/quality of life deterioration per EORTC QLQ-C30
21. Time to physical functioning deterioration per EORTC QLQ-C30
22. Time to role functioning deterioration per EORTC QLQ-C30

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Clinical Trial Information

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Clinical Trial Information

Third parties 10

Locations

10 EU/EEA countries · 100 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 202 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

22 submissions — initial application plus substantial / non-substantial modifications