Durvalumab and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
John L. Villano, MD, PhD
Study ID
NCT03911557
Phase
PHASE2
Status
Completed

Conditions

  • Tumor, Solid

Eligibility Criteria

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

Interventions

  • Durvalumab and Tremelimumab — DRUG
    Durvalumab 1500mg + tremelimumab 75mg via IV infusion Q4W, starting on Week 1, for up to a maximum of 4 doses/cycles followed by durvalumab monotherapy 1500 mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination, for up to a maximum of 2 years of total therapy.

Study Details

This study will examine whether patients with relapsed/refractory solid tumors harboring evidence of somatic hypermutation (intermediate versus high tumor mutational burden) will exhibit improvement in disease progression-free survival with dual Tremelimumab and Durvalumab treatment.

Key Dates

Start date
Jun 8, 2019
Status verified
Nov 2025
Primary completion
Oct 10, 2025
Completion
Oct 10, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with moderate to high tumor mutational burden
    Patients with recurrent or refractory disease in solid tumors naïve to anti-PD-1/PD-L1 or anti-CTLA-4 immunotherapy and have moderate to high tumor mutational burden (TMB)

Primary Outcome Measure

Time-to-progression ratio (TTP) [ Time Frame: 2 years (baseline to follow-up) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Markey Cancer CenterLexingtonKentucky40536-

Find similar trials in Lexington, KY

By research site
Markey Cancer Center· Lexington, KY

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