A Phase 1b Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: November 14, 2013
Last updated: March 23, 2015
Last verified: March 2015

A Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of MPDL3280A and of cobimetinib in patients with metastatic or locally advanced cancer for which no standard of care exists.

Condition Intervention Phase
Drug: Cobimetinib
Drug: MPDL3280A
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 1b Study of the Safety and Pharmacology of MPDL3280A Administered With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events (AE) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Safety: Incidence of dose-limiting toxicities (DLT) [ Time Frame: 28 days following start of combination treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Maximum concentration (Cmax) of MPDL3280A [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Plasma Cmax of Cobimetinib [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: January 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-expansion: cobimetinib + MPDL3280A Drug: Cobimetinib
Fixed dose of cobimetinib adminstered orally
Drug: MPDL3280A
Fixed dose administered by IV
Experimental: Dose-finding: cobimetinib + MPDL3280A Drug: Cobimetinib
Escalating doses of cobimetinib administered orally
Drug: MPDL3280A
Fixed dose administered by IV


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >/= 18 years.
  • Solid tumor that is metastatic, locally advanced or recurrent.
  • ECOG performance status of 0 or 1.
  • Life expectancy >/= 12 weeks.
  • Measurable disease, as defined by RECIST v1.1.
  • Adequate blood and organ function.
  • Use of highly effective contraception.
  • Histological tumor tissue specimen.
  • Patients enrolling in the expansion cohorts in Stage 2 must consent to tumor biopsies and must have one of the following types of cancer:
  • KRAS-mutant metatastic colorectal cancer (mCRC)
  • Non-small cell lung cancer (NSCLC)
  • Melanoma

Exclusion Criteria:

  • Pregnant and lactating women.
  • History of autoimmune disease.
  • Patients with prior stem cell or organ transplant.
  • History of idiopathic pulmonary fibrosis.
  • History of HIV or hepatitis C infection; history of hepatitis B is allowed if infection has resolved (absence of HBsAG).
  • Severe infections within 4 weeks prior to study start; signs or symptoms of infection within 2 weeks prior to study start.
  • Oral or IV antibiotic therapy within 2 weeks prior to study start.
  • Significant cardiovascular disease.
  • Administration of a live, attenuated vaccine within 4 weeks before study start or until the end of the study.

Cancer-Specific Exclusions

  • Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to study start.
  • Active or untreated central nervous system (CNS) tumors.
  • Leptomeningeal disease.
  • Excess, uncontrolled calcium levels.
  • History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment.
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01988896

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01988896     History of Changes
Other Study ID Numbers: GP28363
Study First Received: November 14, 2013
Last Updated: March 23, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 30, 2015