Clinical trial · Interventional
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.
A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced Melanoma
NCT03815058CI-TRIAL-00102076IMCODE001completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autogene cevumeran | Biological | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Safety Run-in Period: Autogene Cevumeran + Pembrolizumab
- 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.
- interventionNames
- Biological: Autogene cevumeran
- Drug: Pembrolizumab
- type
- ACTIVE_COMPARATOR
- label
- Randomized Period: Arm A: Pembrolizumab
- 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.
- interventionNames
- Drug: Pembrolizumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.