Metastatic Urothelial Cancer Clinical Trial
Official title:
Randomized Phase 2 Trial of Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer
This is a randomized phase 2 trial of gemcitabine + carboplatin + nivolumab or gemcitabine + oxaliplatin + nivolumab for the treatment of cisplatin-ineligible patients with metastatic urothelial cancer. Randomization will be stratified on the lymph node only (and/or unresectable primary) metastatic status.
Patients will be randomized to Arm A: gemcitabine plus carboplatin plus nivolumab versus Arm B: gemcitabine plus oxaliplatin plus nivolumab. Randomization will be stratified on the metastasis status (lymph node only vs. the rest). Patients on both treatment arms will receive up to 6 cycles of combination therapy in the absence of prohibitive adverse effects or disease progression. Patients with at least stable disease at the completion of 6 cycles of treatment may continue "maintenance" single agent nivolumab for up to 12 cycles. Patients who require discontinuation of chemotherapy (i.e., gemcitabine plus carboplatin or gemcitabine plus oxaliplatin) prior to Cycle 6, but who have at least stable disease, may be considered for ongoing treatment with single-agent nivolumab on the "maintenance" phase after discussion with the sponsor-investigator. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03682068 -
Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
|
Phase 3 | |
| Recruiting |
NCT05101096 -
Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT02826564 -
Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer
|
Phase 1 | |
| Completed |
NCT01963052 -
ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT05390645 -
A Study of MFA-370 in Patients With Metastatic Urothelial Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03745911 -
Paclitaxel and TAK-228 in Urothelial Carcinoma
|
Phase 2 | |
| Completed |
NCT03390595 -
Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT04995419 -
A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy
|
Phase 2 | |
| Completed |
NCT03679767 -
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
|
Phase 2 | |
| Recruiting |
NCT06225596 -
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
|
Phase 2/Phase 3 | |
| Completed |
NCT02240017 -
A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03547973 -
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
|
Phase 2 | |
| Completed |
NCT03070990 -
A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
|
Phase 1 | |
| Completed |
NCT03448718 -
Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations
|
Phase 2 |