Phase II Open Label Study of IMMU-132 in Metastatic Urothelial Cancer

  • STATUS
    Recruiting
  • End date
    Sep 28, 2021
  • participants needed
    201
  • sponsor
    Immunomedics, Inc.
Updated on 28 October 2020
cancer
measurable disease
metastasis
carboplatin
pembrolizumab
metastatic urothelial carcinoma

Summary

This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 /PD-L1 based immunotherapy.

At least 201 patients are anticipated to be enrolled across approximately 40 sites from North America and Europe.

Description

This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen and/or anti-PD-1 / PD-L1 based immunotherapy.

The primary objective is Objective Response Rate (ORR) based on central review.

The secondary objectives for Cohorts 1 and 2 are Duration of Response (DOR) and Progression Free Survival (PFS) both based on central review and Overall Survival (OS).

The secondary objectives for Cohort 3 are Duration of Response (DOR),Clinical Benefit Rate (CBR), and Progression Free Survival (PFS) based on central review by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; Duration of Response (DOR),Clinical Benefit Rate (CBR), and Progression Free Survival (PFS) based on central review for Immune-based therapeutics (iRECIST) criteria, Overall Survival (OS), safety and tolerability of IMMU-132 in combination with pembrolizumab.

Subjects will receive IMMU-132 10 mg/kg administered intravenously on Days 1 and 8 of a 21-day cycle to be continued in the absence of unacceptable toxicity or disease progression. In Cohort 3, all subjects will first receive IMMU-132 on Days 1 and 8 of a 21-day cycle followed by pembrolizumab at the standard approved dose (200 mg) only on Day 1 of a 21-day cycle. After discontinuation of treatment, patients will have a 30-day safety follow-up after last dose and then will be followed every 12 weeks for survival for a maximum of 2 years.

Details
Treatment Sacituzumab govitecan, Sacituzumab govitecan and pembrolizumab
Clinical Study IdentifierNCT03547973
SponsorImmunomedics, Inc.
Last Modified on28 October 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Transitional cell carcinoma or Urothelial Carcinoma?
Patients with histologically confirmed urothelial cancer
ECOG Performance status score of 0 or 1
Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin)
Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease
Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression 12 months following completion of therapy
Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an anti-PD-1 /PD-L1 therapy
Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Subject may not have received any platinum for treatment of recurrent, metastatic or advanced disease
Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy
Adequate renal and hepatic function
Adequate hematologic parameters without transfusional support
Creatinine clearance 30mL/min as calculated by the Cockroft-Gault formula
Subjects must have a 3-month life expectancy
Have measurable disease by CT or MRI as per RECIST 1.1 criteria

Exclusion Criteria

Women who are pregnant or lactating
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., Grade 1 or at baseline) from adverse events due to a previously administered agent
Requires concomitant medication interfering with ABCA1 transporter or UGT1A1
Has an active second malignancy
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has known active Hepatitis B or Hepatitis C
Has other concurrent medical or psychiatric conditions
Cohort 3: Has active autoimmune disease requiring systemic treatment with steroids or other immunosuppressive agent or any condition that in the Investigator's judgment precludes treatment with pembrolizumab
Cohort 3: Has received a live vaccine within 30 days prior to the first dose of study drug(s)
Cohort 3: Has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis
Cohort 3: Has received anti-PD-1/PD-L1 therapy previously
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet