A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. (IMCODE001)

Genentech

Status and phase: Active, not recruiting; Phase 2

Conditions: Advanced Melanoma

Treatments: Drug: Pembrolizumab; Biological: Autogene cevumeran

Study type: Interventional

Funder types: Industry

Identifiers

NCT03815058

GO40558

2018-001773-24 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Life expectancy >/= 12 weeks;
• Adequate hematologic and end-organ function;
• Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions;
• Tumor specimen availability;
• Measurable disease per RECIST v1.1.

Exclusion criteria

• Ocular/uveal melanoma;
• Any anti-cancer therapy with the exceptions as specified in the protocol;
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
• Previous splenectomy;
• History of autoimmune disease;
• Prior allogeneic bone marrow transplantation or prior solid organ transplantation;
• Positive test for Human Immunodeficiency Virus (HIV) infection;
• Active hepatitis B or C or tuberculosis;
• Significant cardiovascular disease;
• Known clinically significant liver disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 3 patient groups

Safety Run-in Period: Autogene Cevumeran + Pembrolizumab

Experimental group

Description:

Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of autogene cevumeran.

Treatment:

Biological: Autogene cevumeran

Drug: Pembrolizumab

Randomized Period: Arm A: Pembrolizumab

Active Comparator group

Description:

Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with autogene cevumeran plus pembrolizumab (Arm B) after confirmed disease progression.

Treatment:

Drug: Pembrolizumab

Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab

Experimental group

Description:

Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of autogene cevumeran.

Treatment:

Biological: Autogene cevumeran

Drug: Pembrolizumab