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A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab

NCT01975831 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-10-12

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Durvalumab

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

DRUG

Tremelimumab

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

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Jedd D Wolchok, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-19
Primary Completion
2019-12-31
Completion
2021-07-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975831 on ClinicalTrials.gov