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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)

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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)

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

Trial contacts and locations

57

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Data sourced from clinicaltrials.gov

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