A Study of Sacituzumab Govitecan in People With Mesothelioma
Phase 2 Study of Sacituzumab Govitecan-hziy in Patients With Previously Treated Mesothelioma
1 other identifier
interventional
33
1 country
7
Brief Summary
Participants will receive sacituzumab govitecan until their disease gets worse (progresses), they have severe side effects and cannot continue study treatment, or the participants or the study doctor thinks it's in your best interest to stop treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2024
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2024
CompletedStudy Start
First participant enrolled
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 21, 2029
May 5, 2026
April 1, 2026
5 years
June 21, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Clinical efficacy of SG in participants with recurrent and/or unresectable/metastatic DPM treated past the Cycle 3 tumor assessment determined by overall response rate as primarily assessed by modified (m)RECIST. Overall response rate defined as participants who achieve complete response or partial response as best overall response by modified RECIST v1.1 criteria for mesothelioma.
2 years
Study Arms (1)
Participants with Mesothelioma
EXPERIMENTALParticipants will have pathologically confirmed diffuse pleural mesothelioma. Patients will undergo cross-sectional imaging after the first 2 cycles and subsequently after every 3 cycles until disease progression. Biopsies will take place at screening, prior to cycle 3, and an optional biopsy at the end of treatment if consent was obtained and deemed to be safe and feasible. Patients treated on study who are removed prior to the Cycle 3 tumor assessment will be evaluated for toxicity only and replaced. All patients treated past the Cycle 3 tumor assessment will be include in the toxicity and efficacy assessments.
Interventions
After enrollment, participants will receive SG until disease progression or intolerable toxicity.
Eligibility Criteria
You may qualify if:
- Patient, or legally authorized representative (LAR), willing and able to provide written informed consent for the trial
- Patient age ≥ 18 at time of consent
- Pathologically confirmed diffuse pleural mesothelioma
- Must have received at least one prior systemic therapy (platinum/pemetrexed, immunotherapy or a combination thereof)
- Measurable disease as defined primarily by the modified RECIST criteria for mesothelioma (at PI discretion RECIST v1.1 may be used)
- Consent to undergo a biopsy prior to Cycle 1 Day 1 and Cycle 3 Day 1 if deemed medically safe and feasible
- Eastern Cooperative Oncology Group (ECOG) score 0 or Karnofsky Performance Status ≥ 70%
- Adequate organ function, defined as
- Absolute neutrophil count ≥ 1.5K/mcL
- Platelet count ≥ 100K/mcL
- Adequate renal function defined as creatinine clearance ≥ 30ml/min (as calculated by Cockcroft-Gault Formula)
- Hemoglobin \> 9g/dL (prior transfusion permitted if not within 7 days of enrollment)
- Total bilirubin ≤1.5 x upper limit of normal (ULN) if no liver metastases or \<3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits
- AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN)
- If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 months after the end of active therapy
You may not qualify if:
- Currently participating in another study and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment
- Prior hypersensitivity to irinotecan or any components of sacituzumab govitecan-hziy
- Prior cytotoxic/immunologic systemic therapy within 3 weeks prior to study Day 1 or has not recovered (i.e., CTCAE v5 ≥ Grade 1 at baseline; from clinically significant adverse events due to a previously administered agent (excluding Grade 2 neuropathy)
- Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial within the opinion of the investigator
- Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, or in situ cervical cancer after definitive treatment
- Positive hepatitis B (hepatitis B virus \[HBV\]) surface antigen (HBsAg)
- o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Patients who fit these criteria must use Hep B prophylaxis during treatment. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing
- Positive hepatitis C antibody (anti-HCV)
- o NOTE: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible
- Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:
- Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment)
- CD4 count \< 350 cells/mm3 at screening
- AIDS-defining opportunistic infection within 6 months of start of screening
- Not agreeing to start ART and be on ART \> 4 weeks plus having HIV viral load \<400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIV controlled)
- Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or coronary/peripheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Sciencescollaborator
- Memorial Sloan Kettering Cancer Centerlead
Study Sites (7)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Offin, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2024
First Posted
June 27, 2024
Study Start
June 21, 2024
Primary Completion (Estimated)
June 21, 2029
Study Completion (Estimated)
June 21, 2029
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.