A Study to Evaluate Enfortumab Vedotin in Subjects With Previously Treated Locally Advanced or Metastatic Malignant Solid Tumours (EV-202)

Official Title

An Open-label, Multicentre, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Previously Treated Locally Advanced or Metastatic Malignant Solid Tumours (EV-202)

Summary:

The primary purpose of this study is to determine the antitumour activity of enfortumab vedotin as measured by confirmed objective response rate (ORR). This study will also assess other measures of antitumour activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin.

Trial Description

Primary Outcome:

  • Confirmed Overall Response Rate (ORR) (Complete Response (CR) and Partial Response(PR)) per RECIST V1.1 per investigator assessment
Secondary Outcome:
  • Duration of Response (DOR) per RECIST V1.1 as per investigator assessment
  • Disease Control Rate (DCR) per RECIST V1.1 as per investigator assessment
  • Duration of Progression Free Survival (PFS) per RECIST V1.1 as per investigator assessment
  • Duration of Overall Survival (OS)
  • Number of participants with Adverse Events (AEs)
  • Number of participants with laboratory value abnormalities and/or adverse events (AEs)
  • Number of participants with vital sign abnormalities and /or adverse events (AEs)
  • Number of participants with routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
  • Number of participants at each grade of the Eastern Cooperative Oncology Group Performance Status (ECOG PS)

This study will consist of 3 periods: screening/baseline, treatment and follow-up.

Screening/baseline period will take place up to 28 days prior to the first dose of study treatment.

In the treatment period, starting at cycle 1, participants will receive enfortumab vedotin on days 1, 8, and 15 every 28-day cycle until one of the treatment discontinuation criteria are met. Disease assessment will be performed at screening/baseline and repeated every 8 weeks (56 days ± 7 days) from the first dose of study treatment throughout the study until the participant has radiologically confirmed disease progression, initiates a new subsequent anticancer therapy, dies, withdraws consent, is lost to follow-up or the study closes, whichever occurs first.

Participants who discontinue study treatment for reasons other than radiologically-confirmed disease progression by RECIST Version 1.1 will enter into a post treatment follow-up period and continue to receive imaging scans every 8 weeks (56 days ± 7 days) until the subject has radiologically confirmed disease progression, initiates a new anticancer therapy, dies, withdraws consent, is lost to follow-up or the study closes, whichever occurs first.

After 1 year on study treatment, the frequency of disease assessment will be reduced to every 12 weeks (84 days ± 7 days).

After radiologically-confirmed disease progression or initiation of subsequent anticancer therapy, whichever occurs first, participants will be contacted every 12 weeks in the long-term follow-up period for survival status until death, withdrawal of consent, lost to follow-up or study closure, whichever occurs first.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society