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. Author manuscript; available in PMC: 2021 Jul 21.
Published in final edited form as: Expert Rev Anticancer Ther. 2020 Jul 21;20(7):551–561. doi: 10.1080/14737140.2020.1782201

Table 3.

Ongoing trials of novel antibody-drug conjugates in advanced urothelial cancer.

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