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 currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01988896
First received: November 14, 2013
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

A Phase Ib, open-label, multicenter study designed to assess the safety, tolerab ility, 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
Neoplasms
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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 90
Study Start Date: December 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988896

Contacts
Contact: Reference Study ID Number: GP28363 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, California
Not yet recruiting
Stanford, California, United States, 94305
United States, Colorado
Not yet recruiting
Denver, Colorado, United States, 80220
United States, Connecticut
Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Not yet recruiting
Port Saint Lucie, Florida, United States, 34952
United States, Maryland
Not yet recruiting
Kensignton, Maryland, United States, 20895
United States, Massachusetts
Not yet recruiting
Boston, Massachusetts, United States, 01770
Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Not yet recruiting
Novi, Michigan, United States, 48322
United States, New York
Recruiting
New York, New York, United States, 10065
United States, North Carolina
Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Not yet recruiting
Arlington, Texas, United States, 76012
Not yet recruiting
Houston, Texas, United States, 77030
Not yet recruiting
San Antonio, Texas, United States, 78229
Not yet recruiting
Tyler, Texas, United States, 75702
United States, Washington
Recruiting
Seattle, Washington, United States, 98195
Not yet recruiting
Vancouver, Washington, United States, 98684
Australia, Victoria
Not yet recruiting
East Melbourne, Victoria, Australia, 3002
Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Not yet recruiting
Parkville, Victoria, Australia, 3050
Canada, Ontario
Not yet recruiting
Hamilton, Ontario, Canada, L8V 5C2
Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Not yet recruiting
Montreal, Quebec, Canada, H3A 1A1
Not yet recruiting
Montréall, Quebec, Canada, H2L 4M1
Czech Republic
Not yet recruiting
Brno, Czech Republic, 656 53
Not yet recruiting
Ostrava - Poruba, Czech Republic, 708 52
France
Not yet recruiting
Marseille, France, 13385
Not yet recruiting
Toulouse, France, 31059
Not yet recruiting
Villejuif, France, 94805
Germany
Not yet recruiting
Berlin, Germany, 12200
Not yet recruiting
Dresden, Germany, 01307
Not yet recruiting
Freiburg, Germany, 79106
Not yet recruiting
Heidelberg, Germany, 69120
Korea, Republic of
Not yet recruiting
Seoul, Korea, Republic of, 110744
Not yet recruiting
Seoul, Korea, Republic of, 138-736
Singapore
Not yet recruiting
Singapore, Singapore, 188770
Not yet recruiting
Singapore, Singapore, 119074
Spain
Not yet recruiting
Barcelona, Spain, 08035
Not yet recruiting
Sevilla, Spain, 41013
Not yet recruiting
Valencia, Spain, 46010
Sweden
Not yet recruiting
Solna, Sweden, 17176
Not yet recruiting
Örebro, Sweden, 70185
United Kingdom
Not yet recruiting
Glasgow, United Kingdom, G12 0YN
Not yet recruiting
London, United Kingdom, EC1M 6BQ
Not yet recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014