CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 104 enrolled
Drug / intervention
Durvalumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01975831
NCT01975831Phase 1Completed
CompareCT.gov

A Phase 1 Study to Evaluate the Safety and Tolerability of Anti-PD-L1, MEDI4736, in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Ludwig Institute for Cancer Research·interventional·Posted Nov 5, 2013·Updated Oct 12, 2022

In Brief

A Phase 1 clinical trial evaluating Durvalumab and Tremelimumab for Breast Cancer and 4 related conditions. Completed, enrolled 104 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Ovarian Cancer, Colorectal Cancer, Cervical Cancer, Renal Cell Carcinoma
CountriesUnited States
CollaboratorsMedImmune LLC, Cancer Research Institute, New York City

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartDec 19, 2013
Primary CompletionDec 1, 2019
Study CompletionJul 2, 2021
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 12.7 years ago

Interventions

Durvalumabdrug

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

Tremelimumabdrug

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