Clinical trial NCT02527434: Study of Tremelimumab in Patients With Advanced Solid Tumors
Official title: A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urothelial Bladder Cancer
Triple-negative Breast Cancer
Pancreatic Ductal Adenocarcinoma
Keywords: Urothelial bladder cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Advanced Solid Tumors, Tremelimumab, MEDI4736, ORR
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-08-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 150
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

Detailed description: This is an open-label, multi-center study to determine the efficacy and safety of tremelimumab in the treatment of different cohorts of patients with selected advanced solid tumors. If eligible and at the discretion of the Investigator, after confirmed disease progression on tremelimumab monotherapy or during follow-up, patients will have the option of being sequenced to MEDI4736 (MedImmune 4736) monotherapy or MEDI4736 + tremelimumab combination therapy, for up to 12 months or until disease progression, whichever comes sooner.

Eligibility criteria: Inclusion Criteria:

1. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements.

Exclusion criteria:

1. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient

Primary outcomes:
measure: Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase
timeFrame: From baseline to 12 months in the tremelimumab monotherapy phase
Secondary outcomes:
measure: Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase
timeFrame: From baseline to 12 months in the tremelimumab monotherapy phase
measure: Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase
timeFrame: From baseline to 12 months in the tremelimumab monotherapy phase
measure: Median PFS During Tremelimumab Monotherapy Phase
timeFrame: From baseline to 12 months in the tremelimumab monotherapy phase
measure: Best Objective Response (BoR) During Tremelimumab Monotherapy Phase
timeFrame: From baseline to 12 months in the tremelimumab monotherapy phase
measure: Median Overall Survival (OS) During Tremelimumab Monotherapy Phase
timeFrame: From baseline to final data cut-off date
measure: Percentage of Patients With Confirmed Overall Response During Retreatment Phase
timeFrame: From baseline to 12 months in retreatment phase
measure: Median DoR During Retreatment Phase
timeFrame: From baseline to 12 months in retreatment phase
measure: DCR During Retreatment Phase
timeFrame: From baseline to 4 months in retreatment phase
measure: Median PFS During Retreatment Phase
timeFrame: From baseline to 12 months in retreatment phase
measure: BoR During Retreatment Phase
timeFrame: From baseline to 12 months in retreatment phase
measure: Median OS During Retreatment Phase
timeFrame: From baseline in retreatment phase to final data cut-off date
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Research Site
state: California
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Brussels
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
Study officials:
affiliation: Anderson Cancer Center, the University of Texas
name: Sharma Padmanee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: