Phase 2
N=64
Study of Tremelimumab in Patients With Advanced Solid Tumors
Urothelial Bladder Cancer · Triple-negative Breast Cancer · Pancreatic Ductal Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02527434 ↗Enrolled (actual)
64
Serious AEs
49.4%
Results posted
Mar 2019
Primary outcome: Primary: Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase — 18.8; 8.3; 0.0 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tremelimumab monotherapy (Biological); MEDI4736 monotherapy (Biological); MEDI4736 + tremelimumab combination therapy (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase |
18.8; 8.3; 0.0 | — |
| SECONDARY Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase |
NA; 12.9; NA | — |
| SECONDARY Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase |
25.0; 8.3; 0.0; 21.9; 8.3; 0.0 | — |
| SECONDARY Median PFS During Tremelimumab Monotherapy Phase |
2.63; 3.58; 1.77 | — |
| SECONDARY Best Objective Response (BoR) During Tremelimumab Monotherapy Phase |
6.3; 0.0; 0.0; 12.5; 8.3; 0.0 | — |
| SECONDARY Median Overall Survival (OS) During Tremelimumab Monotherapy Phase |
10.32; 12.88; 3.98 | — |
| SECONDARY Percentage of Patients With Confirmed Overall Response During Retreatment Phase |
0.0; 0.0; 0.0; 25.0; 0.0 | — |
| SECONDARY Median DoR During Retreatment Phase |
NA; NA; NA; 7.3; NA | — |
| SECONDARY DCR During Retreatment Phase |
28.6; 20.0; 25.0; 25.0; 0.0 | — |
| SECONDARY Median PFS During Retreatment Phase |
2.83; 0.99; 2.86; 2.86; 1.84 | — |
| SECONDARY BoR During Retreatment Phase |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Median OS During Retreatment Phase |
11.86; 33.05; 7.18; 16.53; 4.14 | — |
Summary
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors
Eligibility Criteria
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; 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
- 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
Data sourced from ClinicalTrials.gov (NCT02527434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.