Phase 2
N=36
Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer
Urothelial Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03240016 ↗Enrolled (actual)
36
Serious AEs
47.2%
Results posted
Jan 2025
Primary outcome: Primary: Percentage of Patients That Respond to Treatment — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pembrolizumab (Drug); Abraxane (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients That Respond to Treatment |
18 | — |
| SECONDARY Duration of Response |
4.4 | — |
| SECONDARY Progression Free Survival Time |
6.8 | — |
| SECONDARY Median Number of Patients Alive at 12 and 24 Months |
0.83; 0.77 | — |
| SECONDARY Median Duration of Therapy |
157 | — |
| SECONDARY Percentage of Patients That Completely Respond to Treatment |
3 | — |
Summary
This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1 (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer.
Each cycle last 21-days. All subjects will receive pembrolizumab via IV on day 1, and abraxane via IV on Day 1 and Day 8 of each cycle. Subjects may continue to receive the study regimen until they experience disease progression or unacceptable toxicity.
Eligibility Criteria
Inclusion Criteria
- Patients with recurrent unresectable locally advanced or metastatic urothelial carcinoma (aka transitional cell carcinoma).
- Patients may be either cisplatin-ineligible or platinum-refractory.
- Histological or cytologically proven urothelial carcinoma.
- Have measurable disease based on RECIST 1.1
- Has urothelial cancer that is not suitable for local therapy administered with curative intent if not already administered.
- Must have recovered (i.e., AE 1 peripheral neuropathy is NOT permitted
- If subjects received major surgery they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting trial therapy
- Has a known additional malignancy that is progressing or requires active treatment
- Has a history of severe hypersensitivity reaction to nab-paclitaxel or anti-PD1/PDL1
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Pregnancies:
- Females: nab-paclitaxel can cause harm to an unborn child if given to a pregnant woman. Females may not take part in this study if pregnant or breast-feeding for 6 months after last dose of study drug.
- Males: Male subjects should avoid fathering a child while receiving study medication and for 6 months after the last dose of study medication. Males must agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication.
- Subjects (both males and female) should practice effective contraception during study and for 6 months after the last dose of study medication (Section 3.1.8 i, ii).
- Patients with biliary obstruction or biliary stent are excluded.
Data sourced from ClinicalTrials.gov (NCT03240016). 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.