Table 3.
Trial | Design | Setting | Arm(s) / Cohort(s) | Primary Endpoint(s) | |
---|---|---|---|---|---|
Nectin-4 / Enfortumab vedotin | EV-302 (NCT04223856) | Randomized Phase III | Front-line, Cisplatin-Eligible | 1) EV + Pembro 2) Gem/Cis or Gem/Carbo 3) EV + Pembro + Cis or Carbo |
PFS & OS |
EV-201 (Cohort 2) (NCT03219333) | Single-Arm Phase II | Platinum-Naïve and Cisplatin-ineligible | EV monotherapy | ORR | |
EV-301 (NCT03474107) | Randomized Phase III | Platinum- and Checkpoint Blockade-Refractory | 1) EV monotherapy 2) Chemotherapy (docetaxel, vinflunine, or paclitaxel) |
OS | |
EV-103 (NCT03288545) | Multicohort Phase I/II | Multiple* | 1) EV monotherapy 2) EV + Pembro 3) EV + Pembro + (Cis or Carbo) 4) EV + Cis 5) EV + Carbo 6) EV + Gem |
Safety & ORR | |
MORPHEUS mUC (NCT03869190) | Multicohort Phase I/II | Platinum-Refractory | Atezo + EV | ORR | |
Trop-2 / Sacituzumab govitecan | TROPHY-U-01 (NCT03547973) | Single-Arm Multicohort Phase II | Checkpoint Blockade Refractory and Platinum-Refractory or Ineligible | Sacituzumab Govitecan | ORR |
Her-2 | NCT03523572 | Multicohort Phase Ib | Platinum-Refractory | Trastuzumab Deruxtecan + Nivo | Safety & ORR |
NCT04073602 | Single Arm Phase II | Chemotherapy- Refractory | RC48-ADC monotherapy | ORR |
Two cohorts of MIBC will assess pCR rate