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

November 14, 2013
August 26, 2014
December 2013
October 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01988896 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 1b Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1b Study of the Safety and Pharmacology of MPDL3280A Administered With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • Drug: Cobimetinib
    Fixed dose of cobimetinib adminstered orally
  • Drug: Cobimetinib
    Escalating doses of cobimetinib administered orally
  • Drug: MPDL3280A
    Fixed dose administered by IV
  • Experimental: Dose-expansion: cobimetinib + MPDL3280A
    Interventions:
    • Drug: Cobimetinib
    • Drug: MPDL3280A
  • Experimental: Dose-finding: cobimetinib + MPDL3280A
    Interventions:
    • Drug: Cobimetinib
    • Drug: MPDL3280A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
October 2016
October 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Reference Study ID Number: GP28363 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Australia,   Canada,   Czech Republic,   France,   Germany,   Korea, Republic of,   Singapore,   Spain,   Sweden,   United Kingdom
 
NCT01988896
GP28363
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP