At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed non-muscle invasive urothelial carcinoma (Ta, T1, or Tis) on TURBT within 60 days of registration
- ✓Mixed histologies permitted if urothelial carcinoma component present
- ✓Age ≥18 years at time of consent
- ✓ECOG performance status 0 or 1
- ✕Muscle-invasive (T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma
- ✕Another active second malignancy (except non-melanoma skin cancers and biochemical relapsed prostate cancer)
- ✕Anti-cancer therapy (chemotherapy, immunotherapy, monoclonal antibodies) ≤4 weeks prior to study drug start
- ✕Unresolved Grade ≥2 toxicity from prior anticancer therapy (except alopecia, vitiligo, laboratory values in inclusion criteria)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PhAse 1/2 StuDy of Modern ImmunotherApy in BCG-Unresponsive, BCG-RelaPsing, and High-Risk BCG-Naive Non-muscle Invasive UroThelial Carcinoma of the BLADDER
In Brief
A Phase 2 clinical trial evaluating Durvalumab (Cohort 1-3), External Beam Radiotherapy (EBRT), and 6 other interventions for Urothelial Carcinoma and Bladder Cancer. Currently recruiting, targeting 55 participants across 12 sites.
Detailed Summary
Upon successful screening and registration, enrollment to durvalumab monotherapy (cohort 1) will begin. If DLT criteria outlined in the protocol are exceeded with durvalumab monotherapy (cohort 1), the study will close. Provided the safety of durvalumab monotherapy is established, enrollment to combination regimen cohorts will proceed. Cohorts will simultaneously enroll in parallel to each other with patients assigned to cohorts based on patient slot availability and study site choice of radiation arm participation. Patient assignment to future phase 1 arms would proceed similarly. Within BCG-containing cohorts, treatment will begin at full-dose BCG. If DLT criteria outlined in Section 5.1.4 are exceeded with full-dose BCG, a one level dose reduction of BCG will be implemented. If DLT criteria outlined in Section 5.1.4 are exceeded with reduced-dose BCG, the BCG-containing cohort will not proceed to Phase 2 of the study. Similarly, if DLT criteria outlined in Section 5.1.4 are exceeded within non-BCG containing cohorts, the non-BCG containing cohort will not proceed to phase 2 of the study. Due to the prolonged half-life of antibody therapies, no dose adjustments are planned for durvalumab in any of the cohorts.
Study Details
Timeline
Interventions
Durvalumab 1120 mg intravenously Day 1 every 21 days x 8 cycles.
EBRT 6 Gy x 3; Cycle 1 Day 1, 3, and 5
Dose level 0 (starting dose) = Full-dose Dose level-1 = 1/3rd-dose BCG. Dose level -1 is expected to be utilized during the phase II portion of the study due to the ongoing and persistent shortage of BCG in the US.
Gemcitabine 1000 mg intravesical weekly (+/- 2 days) x 6 doses
Docetaxel 37.5 mg intravesical weekly (+/- 2 days) x 6 doses.
Tremelimumab 75 mg intravenously Day 1 (+/- 2 days) every 28 days x 4 cycles.
Durvalumab 1500 mg intravenously Day 1 (+/- 2 days) every 28 days x 6 cycles.
Other regimens to be determined