Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bl⦠(NCT04383743) | Clinical Trial Compass
CompletedPhase 2
Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer
United States17 participantsStarted 2020-11-24
Plain-language summary
This pilot study is evaluating how well pembrolizumab and combination chemotherapy before surgery work for the treatment of specific types of muscle-invasive bladder cancer that have unusual appearance (variants). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, adriamycin, and cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and combination chemotherapy before surgery may work better in treating patients with these muscle invasive bladder cancer variants compared to chemotherapy alone.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically confirmed diagnosis of muscle invasive bladder cancer (cT2-T4a, N0-N1, M0 clinical stage per American Joint Commission on Cancer \[AJCC\]). Clinical node-positive (N1) patients are eligible provided the lymph nodes (LNs) are confined to the true pelvis and are within the planned surgical LN dissection template
* Histology must be either pure or predominant non-urothelial histology (noted on any TURBT)
* Participants must be deemed eligible for cisplatin-based chemotherapy, radical cystectomy (RC) and pelvic lymph node dissection (PLND) by urologist and medical oncologist
* Patients must agree to undergo curative intent surgery
* TURBT that showed muscularis propria invasion should be within 12 weeks prior to beginning study therapy. Patients must have available tumor tissue from either initial or repeat TURBT, prior to starting study therapy. Archival tumor tissue sample of a tumor lesion (TURBT specimen) should be provided and must contain muscle invasive component, at least \>= T2 tumor. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory, preferably within 14 days from the date slides are cut if possible. Patient must be willing to provide tumor tissue for research. Research samples will not be used for any studies unrelated to this trial
* Must have clinical non-metastatic bladder cancerā¦
What they're measuring
1
Pathologic Complete Response Rate
Timeframe: At time of radical cystectomy at approximately within 10 weeks of last neoadjuvant infusion