A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | January 8, 2019 |
| End Date: | July 22, 2022 |
| Contact: | Reference Study ID Number: GO40558 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global-roche-genentech-trials@gene.com |
| Phone: | 888-662-6728 (U.S. and Canada) |
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
This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported
outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients
with previously untreated advanced melanoma.
outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients
with previously untreated advanced melanoma.
Inclusion Criteria:
- 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 the exceptions
as specified in the protocol
- Tumor specimen availability
- Measurable disease per RECIST v1.1
Exclusion criteria:
- Ocular or acral melanoma
- Any anti cancer therapy with the exceptions as specified in the protocol
- Symptomatic, untreated, or actively progressing 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
We found this trial at
10
sites
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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