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Clinical Trials in Germany / NCT04835805
Active, not recruiting Phase 1

A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.

NCT04835805 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1
Started
2021-05-13
Last updated
2026-07-01

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Belvarafenib →Cobimetinib →Nivolumab →

Belvarafenib: Twice daily (BID), continuous dosing

Cobimetinib: Once daily (QD) or three times weekly (TIW) for 21 days, 7 days off

Nivolumab: Once every 4 weeks (Q4W)

Study summary

This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * ECOG Performance Status of 0 or 1 * Histologically confirmed, metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage III) cutaneous melanoma, that has progressed on or after treatment with anti-PD-1 or anti-PD-L1 therapy. Patients may have received up to two lines of systemic cancer therapy. Treatment with anti-PD-1/PD-L1 in the adjuvant setting is acceptable. Patients must have progressed disease at study entry * Documentation of NRAS mutation-positive within 5 years prior to screening * Tumor specimen availability * Adequate hematologic and end-organ function * Measurable disease per RECIST v1.1 Exclusion Criteria: * Prior treatment with a pan-RAF inhibitor * Treatment with systemic immunotherapy agents (e.g., anti-CTLA4, anti-PD(L)1, cytokine therapy, investigational therapy, etc.) within 28 days prior to C1D1 * Symptomatic, untreated, or actively progressing CNS metastases * History or signs/symptoms of clinically significant cardiovascular disease * Known clinically significant liver disease * History of autoimmune disease or immune deficiency * Prior treatment with a MEK inhibitor (cobimetinib arm) * History of or evidence of retinal pathology on ophthalmologic examination (cobimetinib arm) * History of immune-related AE attributed to prior anti-PD(L)1 therapy that resulted in permanent discontinuation of anti-PD(L)1 therapy (nivolumab arm)

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
California Pacific Medical Center Research Institute San Francisco California
UCSF Helen Diller Family CCC San Francisco California
University of Colorado Cancer Center Aurora Colorado
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
Washington University School of Medicine St Louis Missouri
Memorial Sloan Kettering New York New York
Calvary Mater Newcastle Waratah New South Wales
Peter MacCallum Cancer Centre-East Melbourne Melbourne Victoria
Linear Clinical Research Ltd Nedlands Western Australia
Ottawa Hospital Regional Cancer Centre Ottawa Ontario
Princess Margaret Hospital Toronto Ontario
Charité - Universitätsmedizin Berlin Berlin Germany
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany
Klinikum Mannheim GmbH Universitätsklinikum Mannheim Germany
Universitatsklinikum Tubingen Tübingen Germany
Universitätsklinikum Würzburg Würzburg Germany
Asan Medical Center - PPDS Seoul South Korea
Samsung Medical Center - PPDS Seoul South Korea

On this site

📄 Opdivo (nivolumab) drug profile →

More Genentech, Inc. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04835805 on ClinicalTrials.gov ↗ ← All trials in Germany