A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma

Melanoma Clinical Trial

Official title:

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246916
• Other study ID #: R3767-ONC-22122
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 19, 2024
• Est. completion date: June 26, 2033

Study information

• Verified date: April 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.

The study is looking at several other research questions, including:

• What side effects may happen from taking the study drugs.

• How much study drug is in the blood at different times.

• Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: June 26, 2033
• Est. primary completion date: March 22, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.

2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.

3. Measurable disease per RECIST version 1.1.

4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =1.

5. Adequate bone marrow, hepatic, and kidney function.

Key Exclusion Criteria:

Medical Conditions:

1. Uveal, acral or mucosal melanoma.

2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.

3. 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. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.

4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol.

Prior/Concomitant Therapy:

5. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol

6. Systemic immune suppression as described in the protocol.

Other Comorbidities:

7. Participants with a history of myocarditis.

8. Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN).

9. Active or untreated brain metastases or spinal cord compression as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• fianlimab
Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
• cemiplimab
IV administration Q3W in combination with fianlimab
• relatlimab+nivolumab
IV administration every 4 weeks (Q4W)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)		Up to 72 months
Secondary	Progression free survival (PFS) RECIST version 1.1 based on BICR		Up to 72 months
Secondary	Death from any cause		Up to 72 months
Secondary	Overall survival (OS)		Up to 72 months
Secondary	Duration of Response (DOR) by BICR		Up to 72 months
Secondary	DOR by investigator assessment		Up to 72 months
Secondary	Disease control rate (DCR) by BICR		Up to 72 months
Secondary	DCR by investigator assessment		Up to 72 months
Secondary	ORR based on investigator assessment according to RECIST version 1.1		Up to 72 months
Secondary	PFS based on investigator assessment according to RECIST version 1.1		Up to 72 months
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Up to 72 months
Secondary	Incidence of serious adverse events (SAEs)		Up to 72 months
Secondary	Incidence of immune-mediated adverse events (imAEs)		Up to 72 months
Secondary	Occurrence of interruption of study drug(s) due to AEs		Up to 72 months
Secondary	Occurrence of discontinuation of study drug(s) due to AEs		Up to 72 months
Secondary	TEAEs leading to death		Up to 72 months
Secondary	Incidence of laboratory abnormalities	Grade =3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests	Up to 72 months
Secondary	Concentration of fianlimab in serum		Up to 72 months
Secondary	Concentration of cemiplimab in serum		Up to 72 months
Secondary	Incidence of anti-drug antibodies (ADAs) to fianlimab		Up to 72 months
Secondary	Titer of ADAs to fianlimab		Up to 72 months
Secondary	Incidence of ADAs to cemiplimab		Up to 72 months
Secondary	Titer of ADAs to cemiplimab		Up to 72 months
Secondary	Incidence of neutralizing antibodies (NAbs) to fianlimab		Up to 72 months
Secondary	Incidence of NAbs to cemiplimab		Up to 72 months