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Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)

Primary Purpose

Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lurbinectedin
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor focused on measuring Lurbinectedin, Monotherapy, Urothelial cancer, Poorly differentiated neuroendocrine carcinomas, Homologous recombination deficient-positive malignancies agnostic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent
  2. ≥ 18 years of age
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Adequate organ and bone marrow function
  5. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  6. Have advanced (metastatic/unresectable) cancers in one of the following:

    1. Histologically or cytologically confirmed urothelial cancer
    2. Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma
    3. Histologically or cytologically confirmed homologous recombination deficient-positive malignancies agnostic, which may include endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation
  7. Adequate contraceptive precautions

Exclusion Criteria:

  1. Known symptomatic central nervous system (CNS) metastasis requiring steroids
  2. History of prior malignancy within 2 years of enrollment
  3. Clinically significant cardiovascular disease
  4. Active infection requiring systemic therapy
  5. Significant non-neoplastic liver disease
  6. Prior treatment with trabectedin or lurbinectedin
  7. Treatment with an investigational agent within 4 weeks of enrollment
  8. Received live vaccine with 4 weeks of first dose
  9. Prior allogeneic bone marrow or solid organ transplant
  10. Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
  11. Positive human immunodeficiency virus (HIV) infection at screening

Sites / Locations

  • Stanford Cancer Center
  • Eastern Connecticut Hematology and Oncology
  • Florida Cancer Specialist
  • Sarah Cannon, Florida Cancer Specialist
  • Moffit Cancer Center
  • Pikeville Medical Center
  • Dana Farber
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • Icahn School of Medicine at Mount Sinai
  • Levine Cancer Institute
  • Sarah Cannon, Zangmeister Cancer Center
  • University of Pennsylvania
  • UPMC Hillman Cancer Center Investigational Drug Service
  • Bon Secours Hematology and Oncology
  • Sarah Cannon, Tennesse Oncology
  • MD Anderson
  • Inova Schar Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Urothelial Cancer Cohort

Poorly Differentiated Neuroendocrine Carcinomas Cohort

Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort

Arm Description

Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Outcomes

Primary Outcome Measures

Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first.

Secondary Outcome Measures

Investigator-Assessed Progression Free Survival (PFS) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
PFS is defined as the time from the first dosing date to the date of first documented disease progression or death due to any cause, whichever occurs first.
Investigator-Assessed Time-To-Response (TTR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
TTR is defined as the time from the first dosing date to the date of the first confirmed response (complete response [CR] or partial response [PR]), as assessed by the investigators.
Investigator-Assessed Duration of response (DOR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
DOR is defined as the time from the first confirmed response (complete response [CR] or partial response [PR]) to the date of the first documented tumor progression as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first.
Investigator-assessed Disease Control Rate (DCR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed complete response (CR), or partial response (PR), or stable disease (SD) using the RECIST v1.1 criteria.
Overall Survival (OS) in Participants Treated with Lurbinectedin
OS is defined as the time from the first dosing date to the date of death from any cause. A participant who has not died will be censored at the last known alive date.

Full Information

First Posted
November 8, 2021
Last Updated
August 2, 2023
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05126433
Brief Title
Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
Acronym
EMERGE-201
Official Title
EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
November 23, 2023 (Anticipated)
Study Completion Date
June 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
Detailed Description
This phase 2, multicenter, open-label study is designed to assess the safety and efficacy of lurbinectedin monotherapy in 3 cohorts of participants with high-unmet medical need: advanced (metastatic and/or unresectable) urothelial cancer (UC), poorly differentiated neuroendocrine carcinomas (PD-NEC), and a homologous recombination deficient-positive malignancies agnostic cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Cancer, Poorly Differentiated Neuroendocrine Carcinomas, Homologous Recombination Deficient-Positive Malignancies Agnostic
Keywords
Lurbinectedin, Monotherapy, Urothelial cancer, Poorly differentiated neuroendocrine carcinomas, Homologous recombination deficient-positive malignancies agnostic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urothelial Cancer Cohort
Arm Type
Experimental
Arm Description
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
Arm Title
Poorly Differentiated Neuroendocrine Carcinomas Cohort
Arm Type
Experimental
Arm Description
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
Arm Title
Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort
Arm Type
Experimental
Arm Description
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
Intervention Type
Drug
Intervention Name(s)
Lurbinectedin
Intervention Description
Lurbinectedin 3.2 mg/m^2 intravenous (IV) every 3 weeks (Q3W)
Primary Outcome Measure Information:
Title
Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Description
The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first.
Time Frame
Baseline to disease progression or death, up to 36 weeks.
Secondary Outcome Measure Information:
Title
Investigator-Assessed Progression Free Survival (PFS) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Description
PFS is defined as the time from the first dosing date to the date of first documented disease progression or death due to any cause, whichever occurs first.
Time Frame
Baseline to disease progression or death, up to 36 weeks.
Title
Investigator-Assessed Time-To-Response (TTR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Description
TTR is defined as the time from the first dosing date to the date of the first confirmed response (complete response [CR] or partial response [PR]), as assessed by the investigators.
Time Frame
Baseline to disease progression or death, up to 36 weeks.
Title
Investigator-Assessed Duration of response (DOR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Description
DOR is defined as the time from the first confirmed response (complete response [CR] or partial response [PR]) to the date of the first documented tumor progression as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first.
Time Frame
Baseline to disease progression or death, up to 36 weeks.
Title
Investigator-assessed Disease Control Rate (DCR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Description
DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed complete response (CR), or partial response (PR), or stable disease (SD) using the RECIST v1.1 criteria.
Time Frame
Baseline to disease progression or death, up to 36 weeks.
Title
Overall Survival (OS) in Participants Treated with Lurbinectedin
Description
OS is defined as the time from the first dosing date to the date of death from any cause. A participant who has not died will be censored at the last known alive date.
Time Frame
Baseline and every 3 months, up to 16 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ and bone marrow function Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Have advanced (metastatic/unresectable) cancers in one of the following: Histologically or cytologically confirmed urothelial cancer Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma Histologically or cytologically confirmed homologous recombination deficient-positive malignancies agnostic, which may include endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation Adequate contraceptive precautions Exclusion Criteria: Known symptomatic central nervous system (CNS) metastasis requiring steroids History of prior malignancy within 2 years of enrollment Clinically significant cardiovascular disease Active infection requiring systemic therapy Significant non-neoplastic liver disease Prior treatment with trabectedin or lurbinectedin Treatment with an investigational agent within 4 weeks of enrollment Received live vaccine with 4 weeks of first dose Prior allogeneic bone marrow or solid organ transplant Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening Positive human immunodeficiency virus (HIV) infection at screening
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Eastern Connecticut Hematology and Oncology
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Florida Cancer Specialist
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Sarah Cannon, Florida Cancer Specialist
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Pikeville Medical Center
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Facility Name
Dana Farber
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Sarah Cannon, Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Hillman Cancer Center Investigational Drug Service
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Bon Secours Hematology and Oncology
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Sarah Cannon, Tennesse Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

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