A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Ludwig Institute for Cancer Research
Study ID
NCT01975831
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab was administered as an intravenous (IV) infusion over 60 (± 5) minutes.
  • Tremelimumab — DRUG
    Tremelimumab was administered as an intravenous (IV) infusion over 60 (± 5) minutes.

Study Details

This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed standard treatment. The primary study objective was to determine the maximum tolerated dose (MTD) and safety profile of the durvalumab and tremelimumab combination. Secondary objectives were to evaluate the pharmacokinetics (PK) and immunogenicity of durvalumab and tremelimumab, and the antitumor activity (tumor response, progression-free survival \[PFS\], and overall survival \[OS\]) of the durvalumab and tremelimumab combination. (Note: Collection of PK and immunogenicity samples was removed by amendment; analysis was not done.) Exploratory objectives were to evaluate the biological activity of the durvalumab and tremelimumab combination.

Key Dates

Start date
Dec 19, 2013
Status verified
Oct 2022
Primary completion
Dec 31, 2019
Completion
Jul 2, 2021

Study Design

Enrollment
104 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
    Subjects received durvalumab (0.3 mg/kg every 2 weeks \[Q2W\] for 13 cycles) and tremelimumab (3 mg/kg every 4 weeks \[Q4W\] for 6 cycles, then every 12 weeks \[Q12W\]). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
  • Experimental: Escalation: 1 mg/kg Durva + 3 mg/kg Treme
    Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
  • Experimental: Escalation: 3 mg/kg Durva + 3 mg/kg Treme
    Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
  • Experimental: Escalation: 3 mg/kg Durva + 1 mg/kg Treme
    Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
  • Experimental: Expansion: Ovarian Cancer
    Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
  • Experimental: Expansion: Colorectal Cancer
    Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
  • Experimental: Expansion: Non-triple Negative Breast Cancer
    Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
  • Experimental: Expansion: Renal Cell Carcinoma
    Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
  • Experimental: Expansion: Cervical Cancer
    Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.

Primary Outcome Measure

Number of Subjects With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 36 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06510-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Roswell Park Cancer InstituteBuffaloNew York14203-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Mary Crowley Cancer Research CenterDallasTexas75230-
University of Virginia Division of Hematology and OncologyCharlottesvilleVirginia22903-

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By research site
Yale Cancer Center· New Haven, CTDana-Farber Cancer Institute· Boston, MARoswell Park Cancer Institute· Buffalo, NYMemorial Sloan Kettering Cancer Center· New York, NYMary Crowley Cancer Research Center· Dallas, TXUniversity of Virginia Division of Hematology and Oncology· Charlottesville, VA

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