A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 64
- Locations
- 14
- Primary Endpoint
- Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 150 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •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
- •Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment;
- •History of leptomeningeal carcinomatosis;
- •Active or prior documented autoimmune or inflammatory disorders;
- •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;
- •QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms;
- •Known allergy or hypersensitivity to IP or any IP excipient
Arms & Interventions
treme mono to be sequenced to MEDI4736 mono or combination
tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)
Intervention: Tremelimumab monotherapy (Biological)
treme mono to be sequenced to MEDI4736 mono or combination
tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)
Intervention: MEDI4736 monotherapy (Biological)
treme mono to be sequenced to MEDI4736 mono or combination
tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)
Intervention: MEDI4736 + tremelimumab combination therapy (Biological)
Outcomes
Primary Outcomes
Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase
Time Frame: From baseline to 12 months in the tremelimumab monotherapy phase
Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.
Secondary Outcomes
- Median OS During Retreatment Phase(From baseline in retreatment phase to final data cut-off date)
- Median DoR During Retreatment Phase(From baseline to 12 months in retreatment phase)
- Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase(From baseline to 12 months in the tremelimumab monotherapy phase)
- Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase(From baseline to 12 months in the tremelimumab monotherapy phase)
- Median Overall Survival (OS) During Tremelimumab Monotherapy Phase(From baseline to final data cut-off date)
- Percentage of Patients With Confirmed Overall Response During Retreatment Phase(From baseline to 12 months in retreatment phase)
- DCR During Retreatment Phase(From baseline to 4 months in retreatment phase)
- Median PFS During Retreatment Phase(From baseline to 12 months in retreatment phase)
- BoR During Retreatment Phase(From baseline to 12 months in retreatment phase)
- Median PFS During Tremelimumab Monotherapy Phase(From baseline to 12 months in the tremelimumab monotherapy phase)
- Best Objective Response (BoR) During Tremelimumab Monotherapy Phase(From baseline to 12 months in the tremelimumab monotherapy phase)