RECRUITING

A Study of Sacituzumab Govitecan in People With Mesothelioma

Conditions

Mesothelioma Mesotheliomas Pleural Mesothelioma; Pleura Diffuse Pleural Mesothelioma Sacituzumab 24-081 Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2 Study of Sacituzumab Govitecan-hziy in Patients With Previously Treated Mesothelioma

Quick Facts

Study Start:2024-06-21

Study Completion:2029-06-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06477419

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 by modified RECIST criteria for mesothelioma * 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	* 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) * Positive hepatitis C antibody (anti-HCV) * 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 * Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1 * Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)

Inclusion Criteria

Exclusion Criteria

* 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 by modified RECIST criteria for mesothelioma
* 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

* 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)
* Positive hepatitis C antibody (anti-HCV)
* 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
* Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1
* Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)

Contacts and Locations

Study Contact

Michael Offin, MD

CONTACT

646-608-3763

offinm@mskcc.org

Robert Daly, MD, MBA

CONTACT

646-608-3789

dalyr1@mskcc.org

Principal Investigator

Michael Offin, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Michael Offin, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-21

Study Completion Date2029-06-21

Study Record Updates

Study Start Date2024-06-21

Study Completion Date2029-06-21

Terms related to this study

Keywords Provided by Researchers

Mesothelioma
Mesotheliomas Pleural
Mesothelioma; Pleura
Diffuse Pleural Mesothelioma
Sacituzumab
24-081
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Mesothelioma
Mesotheliomas Pleural
Mesothelioma; Pleura