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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ClinicalTrials.gov Identifier: NCT03815058 |
Recruitment Status :
Active, not recruiting
First Posted : January 24, 2019
Last Update Posted : April 26, 2024
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Condition or disease | Intervention/treatment | Phase |
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Advanced Melanoma | Biological: Autogene cevumeran Drug: Pembrolizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 131 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | January 8, 2019 |
Estimated Primary Completion Date : | October 30, 2025 |
Estimated Study Completion Date : | October 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Safety Run-in Period: Autogene Cevumeran + Pembrolizumab
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.
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Biological: Autogene cevumeran
Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
Other Name: RO7198457 Drug: Pembrolizumab Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Other Name: Keytruda |
Active Comparator: Randomized Period: Arm A: Pembrolizumab
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.
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Drug: Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Other Name: Keytruda |
Experimental: Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab
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.
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Biological: Autogene cevumeran
Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
Other Name: RO7198457 Drug: Pembrolizumab Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Other Name: Keytruda |
- Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization [ Time Frame: The time from randomization to disease progression/death (up to approximately 24 months) ]
- Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization [ Time Frame: Up to approximately 24 months ]
- Overall Survival (OS) After Randomization [ Time Frame: The time from randomization to death from any cause (up to approximately 24 months). ]
- Duration of Response (DOR) According to RECISTv.1.1 After Randomization [ Time Frame: The time from randomization up to approximately 24 months. ]
- Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization [ Time Frame: From randomization up to approximately 24 months. ]The 2-item GHS/HRQoL questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) uses a 7-point scale from 1=very poor to 7= excellent. Score range for GHS/HRQoL is 2-14. A negative change from baseline indicates deterioration in GHS.
- Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over [ Time Frame: Up to 12 months from the time of cross-over ]
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 90 days after the final dose of study drug (up to approximately 27 months) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815058
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT03815058 |
Other Study ID Numbers: |
GO40558 2018-001773-24 ( EudraCT Number ) |
First Posted: | January 24, 2019 Key Record Dates |
Last Update Posted: | April 26, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Skin Neoplasms Neoplasms by Site Skin Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |