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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

Thank you

Trial Information

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


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose-limiting toxicities (DLTs)

Outcome Time Frame:

21 days following the first administration of MPDL3280A

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GP28384

NCT ID:

NCT01656642

Start Date:

August 2012

Completion Date:

April 2015

Related Keywords:

  • Malignant Melanoma
  • PD-L1
  • PD-1
  • PDL1
  • antiPD-L1
  • MPDL3280A
  • Melanoma
  • BRAF
  • MPDL320A
  • Melanoma

Name

Location

Fountain Valley, California  92708
Austin, Texas  78705
Boston, Massachusetts