A Study of The Safety and Pharmacology of MPDL3280A Administered in Combination With Vemurafenib (Zelboraf®) in Patients With Previously Untreated BRAFV600-Mutation Positive Metastatic Melanoma
This study is currently recruiting participants.
Verified April 2013 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01656642
First received: August 1, 2012
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of MPDL3280A in combination with Vemurafenib (Zelboraf®) in previously untreated patients with BRAFV600-mutation positive metastatic melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Melanoma |
Drug: MPDL3280A Drug: Vemurafenib (Zelboraf®) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib, Open-Label Study of The Safety and Pharmacology of MPDL3280A Administered in Combination With Vemurafenib (Zelboraf®) in Patients With Previously Untreated BRAFV600-Mutation Positive Metastatic Melanoma |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 21 days following the first administration of MPDL3280A ] [ Designated as safety issue: No ]
- Nature of dose-limiting toxicities (DLTs) [ Time Frame: 21 days following the first administration of MPDL3280A ] [ Designated as safety issue: No ]
- Incidence of adverse events and laboratory abnormalities graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
- Nature of adverse events and laboratory abnormalities graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
- Severity of adverse events and laboratory abnormalities graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of anti-MPDL3280A antibodies [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
- Change in vital signs, including electrocardiograms (ECGs) [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
- Change in clinical laboratory results [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
- Number of cycles and dose intensity of each component of the treatment regimen [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
MPDL3280A + Zelboraf (vemurafenib)
|
Drug: MPDL3280A
Intravenous repeating dose
Drug: Vemurafenib (Zelboraf®)
Oral repeating dose
|
|
Experimental: B
MPDL3280A + Zelboraf (vemurafenib)
|
Drug: MPDL3280A
Intravenous repeating dose
Drug: Vemurafenib (Zelboraf®)
Oral repeating dose
|
|
Experimental: C
MPDL3280A + Zelboraf (vemurafenib)
|
Drug: MPDL3280A
Intravenous repeating dose
Drug: Vemurafenib (Zelboraf®)
Oral repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologic or cytologic documentation of metastatic melanoma, with BRAFV600 mutation as assessed by cobas® 4800 BRAF V600 Mutation Test. Origin of the primary tumor must be known and may be of skin, mucosal, or acral locations but not of ocular origin.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and end organ function
- Measurable disease per RECIST v1.1
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for 6 months after discontinuation from the study
Exclusion Criteria:
- Receipt of prior systemic anti-cancer therapy for unresectable, locally advanced or metastatic melanoma
- Receipt of prior MAPK inhibitor pathway agents, including MEK kinase inhibitor and BRAF kinase inhibitor
- Major surgical procedure within 28 days prior to Day 1 or anticipation of need for a major surgical procedure during the course of the study
- Radiotherapy </= 14 days prior to Day 1
- Adverse events from prior anti-cancer therapy that have not resolved to Grade <= 1 except for alopecia
- Current severe, uncontrolled systemic disease excluding cancer
- Known clinically significant liver disease
- Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
- Any ongoing malignancy other than melanoma
- History or risk of autoimmune disease
- History of idiopathic pulmonary fibrosis, risk of pulmonary toxicity, or evidence of active pneumonitis on screening chest CT scan
- History of HIV or hepatitis C infection
- Active tuberculosis
- Severe infections within 4 weeks prior to Cycle 1 Day 1 or Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
- Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- History of clinically significant cardiac or pulmonary dysfunction
- Treatment with systemic immunosuppressive medications within 4 weeks prior to Cycle 1 Day 1
- Bisphosphonate therapy for symptomatic hypercalcemia
- Pregnant or lactating women
- Any vemurafenib-specific exclusion criteria
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656642
Contacts
| Contact: Please reference Study ID Number: GP28384 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, California | |
| Recruiting | |
| Los Angeles, California, United States, 90025 | |
| United States, Massachusetts | |
| Not yet recruiting | |
| Boston, Massachusetts, United States, 02215 | |
| Not yet recruiting | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Texas | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01656642 History of Changes |
| Other Study ID Numbers: | GP28384 |
| Study First Received: | August 1, 2012 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
PD-L1 PD-1 PDL1 antiPD-L1 |
MPDL3280A Melanoma BRAF MPDL320A |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on June 17, 2013